{"id":452,"date":"2017-01-27T07:58:31","date_gmt":"2017-01-27T07:58:31","guid":{"rendered":"http:\/\/wwwro.anm.ro\/?page_id=452"},"modified":"2017-04-28T08:03:19","modified_gmt":"2017-04-28T08:03:19","slug":"comunicate-de-presa","status":"publish","type":"page","link":"https:\/\/www.anm.ro\/en\/agentie\/comunicate-de-presa\/","title":{"rendered":"Press releases"},"content":{"rendered":"<div class=\"comunicate\"><ul class=\"display-posts-listing\"><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-27-03-2026\/\">Press release<\/a><div class=\"content\"><p><strong>27.03.2026<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA recommends withdrawal of marketing authorisations for levamisole medicines<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/referral\/levamisole-containing-medicinal-products-article-31-referral-ema-recommends-withdrawal-marketing-authorisations-levamisole-medicines_en.pdf-0\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-13-03-2026\/\">Press release<\/a><div class=\"content\"><p><strong>13.03.2026 <\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nMeeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 &#8211; 12 March 2026: PRAC warns about known risk of aseptic meningitis with chikungunya vaccine Ixchiq<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-9-12-march-2026\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-05-03-2026\/\">Press release<\/a><div class=\"content\"><p><strong>05.03.2026<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nNew guidance on the conduct of clinical trials during public health emergencies in the EU<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/new-guidance-conduct-clinical-trials-during-public-health-emergencies-eu\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-13-02-2026-2\/\">Press release<\/a><div class=\"content\"><p><strong>13.02.2026<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA recommends withdrawal of marketing authorisations for levamisole medicines<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-recommends-withdrawal-marketing-authorisations-levamisole-medicines#related-content-83416\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-13-02-2026\/\">Press release<\/a><div class=\"content\"><p><strong>13.02.2026<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nMeeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 &#8211; 12 February 2026<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-9-12-february-2026\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-05-12-2025\/\">Press release<\/a><div class=\"content\"><p><strong>05.12.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\n<strong>The online platform facilitating the access to clinical trials in Romania has been launched<\/strong><br \/>\nPatients in Romania, their relatives, the medical community and the general public can access information about ongoing clinical trials in Romania, through a new online platform, in Romanian, which is connected to the European Union database.<br \/>\nThe National Agency for Medicines and Medical Devices of Romania (NAMMDR) together with the Health Innovation Hub have developed and launched the online platform facilitating the access to clinical trials in Romania, available at <a href=\"https:\/\/studiiclinice.anm.ro\/\" target=\"_blank\">https:\/\/studiiclinice.anm.ro\/<\/a>.<br \/>\n<a href=\"https:\/\/www.anm.ro\/en\/_\/COMUNICATE DE PRESA\/Comunicat ANMDMR - HUB DE INOVATIE_EN.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-31-10-2025\/\">Press release<\/a><div class=\"content\"><p><strong>31.10.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nMeeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27 &#8211; 30 October 2025<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-27-30-october-2025\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-23-09-2025\/\">Press release<\/a><div class=\"content\"><p><strong>23.09.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nUse of paracetamol during pregnancy unchanged in the EU<br \/>\n<a href=\"\/_\/COMUNICATE DE PRESA\/Press release EMA - Paracetamol - 23 sept 2025.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-19-09-2025\/\">Press release<\/a><div class=\"content\"><p><strong>19.09.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nFirst treatment recommended for rare immunoglobulin-related autoimmune disease<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/first-treatment-recommended-rare-immunoglobulin-related-autoimmune-disease\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-05-09-2025-2\/\">Press release<\/a><div class=\"content\"><p><strong>05.09.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nPRAC starts safety review of levamisole, a medicine used to treat parasitic worm infections<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/prac-starts-safety-review-levamisole-medicine-used-treat-parasitic-worm-infections\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-05-09-2025\/\">Press release<\/a><div class=\"content\"><p><strong>05.09.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nMeeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 1 \u2013 4 September 2025<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-1-4-september-2025\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-03-09-2025\/\">Press release<\/a><div class=\"content\"><p><strong>03.09.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nWarning about sharp rise in illegal medicines sold in the EU<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/warning-about-sharp-rise-illegal-medicines-sold-eu\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-29-08-2025\/\">Press release<\/a><div class=\"content\"><p><strong>29.08.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\n<strong>NAMMDR \u2013 Specifications on establishing the level of compensation of some medicinal products<\/strong><br \/>\nThe National Agency for Medicines and Medical Devices of Romania (NAMMDR) has, according to the law, the responsibility to carry out the technical evaluation of medicinal products in order to establish, among other things, their level of compensation. This process is carried out according to the criteria provided by the legislative framework in force and follows the efficient use of the allocated funds, while ensuring patient access to safe and effective treatments.<br \/>\nThe detailed reports issued by the NAMMDR are made public on the institution&#8217;s website and contain items which are necessary for the evaluation of the measures considered appropriate by the Ministry of Health and the National Health Insurance House (NHIH). Please note that NAMMDR evaluations represent a technical stage, scientifically and legally based, and that the practical implementation of any change in compensation levels shall be carried out as a result of an analysis which also involves a social-economic impact component, through decision of the Ministry of Health, with the consultation of the partners involved.<br \/>\nAn analysis based on the updated data for year 2025 is currently unavailable; it is currently being developed.<br \/>\nThe NAMMDR shall continue to offer its entire specialised support and to collaborate with the Ministry of Health and the National Health Insurance House, in order to ensure the fair access of patients to treatments and transparent and efficient use of the resources of the healthcare system.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-26-08-2025\/\">Press release<\/a><div class=\"content\"><p><strong>26.08.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\n<strong>Information regarding the misuse of the name of the National Agency for Medicines and Medical Devices of Romania (NAMMDR) in misleading advertisements<\/strong><br \/>\nThe National Agency for Medicines and Medical Devices of Romania draws the public&#8217;s attention to the appearance of advertisements erroneously claiming that certain products are &#8220;authorised&#8221;, &#8220;certified&#8221; or &#8220;recommended&#8221; by the NAMMDR, or displaying the institution&#8217;s logo.<br \/>\nThe NAMMDR states that it does not promote or recommend any medicinal product for human use or medical device. The Agency&#8217;s role is to evaluate, authorise and monitor the safety and quality of medicinal products for human use and medical devices placed on the Romanian market.<br \/>\nOfficial and accurate information about the medicinal products for human use authorised for marketing in Romania is available on the Agency&#8217;s website, <a href=\"http:\/\/www.anm.ro\" target=\"_blank\" rel=\"noopener\">www.anm.ro<\/a>, under the <a href=\"https:\/\/nomenclator.anm.ro\/medicamente\" target=\"_blank\" rel=\"noopener\">Index of medicinal products for human use authorised for marketing in Romania<\/a> section.<br \/>\nThe NAMMDR recommends that everyone obtain information exclusively from official sources and seek the advice of a healthcare professional. Also, it is necessary to consult a specialist before starting any new treatment.<br \/>\nThe NAMMDR remains firmly committed to protecting public health and ensuring patients&#8217; access to safe, effective and quality medicinal products for human use.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-01-08-2025\/\">Press release<\/a><div class=\"content\"><p><strong>01.08.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nRybelsus: Risk of medication error due to new tablet formulation<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/medication-error\/rybelsus-risk-medication-error-due-new-tablet-formulation_en.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-25-07-2025-2\/\">Press release<\/a><div class=\"content\"><p><strong>25.07.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nFirst reformulation of an inhaled medicine with environmentally friendly gas propellant<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/first-reformulation-inhaled-medicine-environmentally-friendly-gas-propellant\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-25-07-2025\/\">Press release<\/a><div class=\"content\"><p><strong>25.07.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nNew treatment for Niemann-Pick type C disease; Aqneursa significantly improves neurological signs, symptoms and functioning<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/new-treatment-niemann-pick-type-c-disease\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-11-07-2025\/\">Press release<\/a><div class=\"content\"><p><strong>11.07.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nMeeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7 \u2013 10 July 2025<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-7-10-july-2025\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-20-06-2025-4\/\">Press release<\/a><div class=\"content\"><p><strong>20.06.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nNew stem cell therapy to treat patients with blood cancers<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/new-stem-cell-therapy-treat-patients-blood-cancers\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-20-06-2025-3\/\">Press release<\/a><div class=\"content\"><p><strong>20.06.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nFirst treatment against liver scarring caused by a type of \u2018fatty liver disease\u2019<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/first-treatment-against-liver-scarring-caused-type-fatty-liver-disease\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-20-06-2025-2\/\">Press release<\/a><div class=\"content\"><p><strong>20.06.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nMeasures to minimise risk of suicidal thoughts with finasteride and dutasteride medicines<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/referral\/finasteride-dutasteride-containing-medicinal-products-article-31-referral-measures-minimise-risk-suicidal-thoughts-finasteride-dutasteride-medicines_en.pdf-0\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-20-06-2025\/\">Press release<\/a><div class=\"content\"><p><strong>20.06.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA starts review of sodium oxybate in alcohol dependence<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-starts-review-sodium-oxybate-alcohol-dependence\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-06-06-2025-2\/\">Press release<\/a><div class=\"content\"><p><strong>06.06.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nMeeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 June 2025<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-2-5-june-2025\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-06-06-2025\/\">Press release<\/a><div class=\"content\"><p><strong>06.06.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nPRAC concludes eye condition NAION is a very rare side effect of semaglutide medicines Ozempic, Rybelsus and Wegovy<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/prac-concludes-eye-condition-naion-very-rare-side-effect-semaglutide-medicines-ozempic-rybelsus-wegovy\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-23-05-2025-3\/\">Press release<\/a><div class=\"content\"><p><strong>23.05.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nNew treatment for adults with acute lymphoblastic leukaemia<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/new-treatment-adults-acute-lymphoblastic-leukaemia\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-23-05-2025-2\/\">Press release<\/a><div class=\"content\"><p><strong>23.05.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nChanges to the use of antibiotic azithromycin<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/changes-use-antibiotic-azithromycin\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-23-05-2025\/\">Press release<\/a><div class=\"content\"><p><strong>23.05.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA starts review of ipidacrine-containing medicines<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-starts-review-ipidacrine-containing-medicines\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-08-05-2025\/\">Press release<\/a><div class=\"content\"><p><strong>08.05.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nMeasures to minimise risk of suicidal thoughts with finasteride and dutasteride medicines<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/measures-minimise-risk-suicidal-thoughts-finasteride-dutasteride-medicines\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-07-05-2025\/\">Press release<\/a><div class=\"content\"><p><strong>07.05.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA starts review of Ixchiq (live attenuated chikungunya vaccine)<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-starts-review-ixchiq-live-attenuated-chikungunya-vaccine\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-17-01-2025\/\">Press release<\/a><div class=\"content\"><p><strong>17.01.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nMeeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 January 2025<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-13-16-january-2025\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-13-12-2024\/\">Press release<\/a><div class=\"content\"><p><strong>13.12.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nAlofisel withdrawn from the EU market<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/alofisel-withdrawn-eu-market\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-09-12-2024\/\">Press release<\/a><div class=\"content\"><p><strong>09.12.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nETF statement on the loss of activity of anti-spike protein monoclonal antibodies due to emerging SARS-CoV-2 variants &#8211; An update<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/other\/etf-statement-loss-activity-anti-spike-protein-monoclonal-antibodies-due-emerging-sars-cov-2-variants-december-2024-update_en.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-29-11-2024\/\">Press release<\/a><div class=\"content\"><p><strong>29.11.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nMeeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 November 2024<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-25-28-november-2024\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-15-11-2024\/\">Press release<\/a><div class=\"content\"><p><strong>15.11.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nUpdated advice to minimise risks of interaction between weight loss medicine Mysimba and opioids<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/updated-advice-minimise-risks-interaction-between-weight-loss-medicine-mysimba-opioids\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-14-11-2024\/\">Press release<\/a><div class=\"content\"><p><strong>14.11.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nLeqembi recommended for treatment of early Alzheimer\u2019s disease<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/leqembi-recommended-treatment-early-alzheimers-disease\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-18-10-2024\/\">Press release<\/a><div class=\"content\"><p><strong>18.10.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nTranslarna: EMA re-confirms non-renewal of authorisation of Duchenne muscular dystrophy medicine<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/translarna-ema-re-confirms-non-renewal-authorisation-duchenne-muscular-dystrophy-medicine\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-04-10-2024\/\">Press release<\/a><div class=\"content\"><p><strong>04.10.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA starts safety review of medicines containing finasteride and dutasteride<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/referral\/finasteride-dutasteride-containing-medicinal-products-article-31-referral-review-started_en.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-20-09-2024\/\">Press release<\/a><div class=\"content\"><p><strong>20.09.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA recommends measures to minimise serious outcomes of known side effect with painkiller metamizole<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/referral\/metamizole-containing-medicinal-products-article-107i-referral-ema-recommends-measures-minimise-serious-outcomes-known-side-effect-painkiller-metamizole_en.pdf-0\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-06-09-2024\/\">Press release<\/a><div class=\"content\"><p><strong>06.09.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA recommends measures to minimise serious outcomes of known side effect with painkiller metamizole<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-recommends-measures-minimise-serious-outcomes-known-side-effect-painkiller-metamizole\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-26-07-2024\/\">Press release<\/a><div class=\"content\"><p><strong>26.07.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA advises about risks of using weight loss medicine Mysimba with opioids<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-advises-about-risks-using-weight-loss-medicine-mysimba-opioids\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-24-07-2024\/\">Press release<\/a><div class=\"content\"><p><strong>24.07.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA confirms its recommendation to update the antigenic composition of authorised COVID-19 vaccines for 2024-2025<br \/>\n<a href=\"https:\/\/www.anm.ro\/en\/_\/COMUNICATE DE PRESA\/Comunicat EMA ENG.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-12-07-2024\/\">Press release<\/a><div class=\"content\"><p><strong>12.07.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nMeeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July 2024<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-july-2024\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-28-06-2024-3\/\">Press release<\/a><div class=\"content\"><p><strong>28.06.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nHydroxyprogesterone caproate medicines to be suspended from the EU market<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/referral\/hydroxyprogesterone-containing-medicinal-products-article-31-referral-opinion-following-cmdh-position_en.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-28-06-2024-2\/\">Press release<\/a><div class=\"content\"><p><strong>28.06.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA recommends revoking conditional marketing authorisation for Ocaliva<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-recommends-revoking-conditional-marketing-authorisation-ocaliva\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-28-06-2024\/\">Press release<\/a><div class=\"content\"><p><strong>28.06.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-recommends-non-renewal-authorisation-duchenne-muscular-dystrophy-medicine-translarna-0\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-26-06-2024\/\">Press release<\/a><div class=\"content\"><p><strong>26.06.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEU actions to tackle shortages of GLP-1 receptor agonists<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/eu-actions-tackle-shortages-glp-1-receptor-agonists\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-14-06-2024\/\">Press release<\/a><div class=\"content\"><p><strong>14.06.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nReview of painkiller metamizole started<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/review-painkiller-metamizole-started\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-12-06-2024\/\">Press release<\/a><div class=\"content\"><p><strong>12.06.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nRecommendations of the Executive Steering Group on Shortages and Safety of Medicinal Products on shortage of Glucagon-Like Peptide-1 (GLP-1) receptor agonists<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/other\/recommendations-executive-steering-group-shortages-safety-medicinal-products-shortage-glucagon-peptide-1-glp-1-receptor-agonists_en.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-16-05-2024\/\">Press release<\/a><div class=\"content\"><p><strong>16.05.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nHydroxyprogesterone caproate medicines to be suspended from the EU market.<br \/>\nMedicinal products containing 17-hydroxyprogesterone caproate (17-OHPC) are not authorised for marketing in Romania.<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/hydroxyprogesterone-caproate-medicines-be-suspended-eu-market\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-12-04-2024\/\">Press release<\/a><div class=\"content\"><p><strong>12.04.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nMeeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2024: GLP-1 receptor agonists: available evidence not supporting link with suicidal and self-injurious thoughts and actions<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-april-2024\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-22-03-2024\/\">Press release<\/a><div class=\"content\"><p><strong>22.03.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nSynapse Labs Pvt. Ltd: re-examination confirms suspension of medicines over flawed studies<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/referral\/synapse-article-31-referral-synapse-labs-pvt-ltd-re-examination-confirms-suspension-medicines-over-flawed-studies_en.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-12-03-2024\/\">Press release<\/a><div class=\"content\"><p><strong>12.03.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nMeeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 March 2024<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-4-7-march-2024\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-12-01-2024\/\">Press release<\/a><div class=\"content\"><p><strong>12.01.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nPotential risk of neurodevelopmental disorders in children born to men treated with valproate medicines: PRAC recommends precautionary measures<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/potential-risk-neurodevelopmental-disorders-children-born-men-treated-valproate-medicines-prac-recommends-precautionary-measures\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-12-12-2023-2\/\">Press release<\/a><div class=\"content\"><p><strong>12.12.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nFirst version of the Union list of critical medicines agreed to help avoid potential shortages in the EU<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/first-version-union-list-critical-medicines-agreed-help-avoid-potential-shortages-eu\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-12-12-2023\/\">Press release<\/a><div class=\"content\"><p><strong>12.12.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nQuestions and answers on the Union list of critical medicines<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/other\/questions-and-answers-union-list-critical-medicines_en.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-01-12-2023\/\">Press release<\/a><div class=\"content\"><p><strong>01.12.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nMeeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2023<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-27-30-november-2023\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-31-10-2023\/\">Press release<\/a><div class=\"content\"><p><strong>31.10.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA recommends approval of adapted Nuvaxovid COVID-19 vaccine targeting Omicron XBB.1.5<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-recommends-approval-adapted-nuvaxovid-covid-19-vaccine-targeting-omicron-xbb15\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-18-10-2023\/\">Press release<\/a><div class=\"content\"><p><strong>18.10.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA alerts EU patients and healthcare professionals to reports of falsified Ozempic pens<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-alerts-eu-patients-healthcare-professionals-reports-falsified-ozempic-pens\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-06-10-2023\/\">Press release<\/a><div class=\"content\"><p><strong>06.10.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nRevised transparency rules for the EU Clinical Trials Information System (CTIS)<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/revised-transparency-rules-eu-clinical-trials-information-system-ctis\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-25-09-2023\/\">Press release<\/a><div class=\"content\"><p><strong>26.09.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nThe Ministry of Health and the National Agency for Medicines and Medical Devices of Romania (NAMMDR) continue to carry out controls at the premises of units authorised to perform activities concerning narcotic and psychotropic medicinal products.<br \/>\nCollaboration with the competent institutions in carrying out the investigation related to the suspicion of crimes of trafficking or illicit consumption of narcotic medicinal products is a priority of the Ministry of Health and its subordinated institutions.<br \/>\nAs early as September the 18th this year, NAMMDR inspectors began assessing compliance with the legality of the release of medicinal products containing oxycodone and fentanyl. The inspectors have thus identified more than 500 pharmaceutical units (pharmacies) that carry out operations with these medicinal products. These shall all be inspected over the next period.<br \/>\nThe checks will also aim at the supervision and control of the fulfilment of legal procedures regarding the return and destruction of narcotic and psychotropic medicinal products which no longer correspond from a quality viewpoint, whose shelf life has expired or coming from patients who no longer use them.<br \/>\nMoreover, the Ministry of Health, according to the yearly inspection plan, has started inspection actions, prior to the investigation in question and which will continue over the following period. The subject of these inspections shall be expanded, in order to ensure that all stages of the destruction process provided by law are observed.<br \/>\nIn the immediate future, the Ministry of Health, together with the NAMMDR and other institutions involved in this field, shall initiate a project to amend the regulatory documents in force, with a view to much stricter regulations regarding activities related to psychotropic and narcotic medicinal products.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-14-09-2023\/\">Press release<\/a><div class=\"content\"><p><strong>14.09.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nSpikevax: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/spikevax-ema-recommends-approval-adapted-covid-19-vaccine-targeting-omicron-xbb15\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-01-09-2023\/\">Press release<\/a><div class=\"content\"><p><strong>01.09.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nPRAC recommends new measures to avoid topiramate exposure in pregnancy<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/prac-recommends-new-measures-avoid-topiramate-exposure-pregnancy\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-30-08-2023\/\">Press release<\/a><div class=\"content\"><p><strong>30.08.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nComirnaty: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/comirnaty-ema-recommends-approval-adapted-covid-19-vaccine-targeting-omicron-xbb15\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-16-08-2023\/\">Press release<\/a><div class=\"content\"><p><strong>16.08.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA review of data on paternal exposure to valproate<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-review-data-paternal-exposure-valproate\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-21-07-2023\/\">Press release<\/a><div class=\"content\"><p><strong>21.07.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nStart of a review concerning the conduct of studies at Synapse Labs Pvt. Ltd, India<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/referral\/synapse-article-31-referral-review-started_en.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-19-07-2023\/\">Press release<\/a><div class=\"content\"><p><strong>19.07.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nReflection paper on the use of artificial intelligence in the lifecycle of medicines<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/reflection-paper-use-artificial-intelligence-lifecycle-medicines\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-11-07-2023\/\">Press release<\/a><div class=\"content\"><p><strong>11.07.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA statement on ongoing review of GLP-1 receptor agonists<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-statement-ongoing-review-glp-1-receptor-agonists\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-27-06-2023\/\">Press release<\/a><div class=\"content\"><p><strong>27.06.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nWithdrawal of application for the marketing authorisation of Lagevrio (molnupiravir)<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/medicine-qa\/questions-answers-withdrawal-application-marketing-authorisation-lagevrio-molnupiravir_en.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-23-06-2023\/\">Press release<\/a><div class=\"content\"><p><strong>23.06.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nRefusal of the marketing authorisation for Albrioza (sodium phenylbutyrate \/ ursodoxicoltaurine)<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/smop-initial\/questions-answers-refusal-marketing-authorisation-albrioza-sodium-phenylbutyrate\/ursodoxicoltaurine_en.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-26-05-2023\/\">Press release<\/a><div class=\"content\"><p><strong>26.05.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA recommends revocation of authorisation for sickle cell disease medicine Adakveo<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/referral\/adakveo-article-20-procedure-ema-recommends-revocation-authorisation-sickle-cell-disease-medicine_en.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-12-05-2023-2\/\">Press release<\/a><div class=\"content\"><p><strong>12.05.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nFluoroquinolone antibiotics: reminder of measures to reduce the risk of long-lasting, disabling and potentially irreversible side effects<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/fluoroquinolone-antibiotics-reminder-measures-reduce-risk-long-lasting-disabling-potentially\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-12-05-2023\/\">Press release<\/a><div class=\"content\"><p><strong>12.05.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nReview of hydroxyprogesterone started.<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/referral\/hydroxyprogesterone-containing-medicinal-products-article-31-referral-review-started_en.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-30-03-2023\/\">Press release<\/a><div class=\"content\"><p><strong>30.03.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA recommends approval of Bimervax as a COVID-19 booster vaccine.<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-recommends-approval-bimervax-covid-19-booster-vaccine\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-10-02-2023\/\">Press release<\/a><div class=\"content\"><p><strong>10.02.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nPRAC starts safety review of pseudoephedrine-containing medicines<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/prac-starts-safety-review-pseudoephedrine-containing-medicines\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-27-01-2023-2\/\">Press release<\/a><div class=\"content\"><p><strong>27.01.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nReview of sickle cell disease medicine Adakveo started<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/referral\/adakveo-article-20-procedure-review-sickle-cell-disease-medicine-adakveo-started_en.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-27-01-2023\/\">Press release<\/a><div class=\"content\"><p><strong>27.01.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA confirms measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/referral\/janus-kinase-inhibitors-jaki-article-20-procedure-ema-confirms-measures-minimise-risk-serious-side_en.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-13-01-2023-2\/\">Press release<\/a><div class=\"content\"><p><strong>13.01.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nWithdrawal of marketing authorisations for amfepramone medicines within the EU.<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/referral\/amfepramone-containing-medicinal-products-article-31-referral-withdrawal-marketing-authorisations_en.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-13-01-2023\/\">Press release<\/a><div class=\"content\"><p><strong>13.01.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nMeeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 &#8211; 12 January 2023<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-9-12-january-2023\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-16-12-2022\/\">Press release<\/a><div class=\"content\"><p><strong>16.12.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA recommends withdrawal of pholcodine medicines\u00a0from EU market<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/referral\/ema-recommends-withdrawal-pholcodine-medicines-eu-market_en.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-06-12-2022-2\/\">Press release<\/a><div class=\"content\"><p><strong>06.12.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nETF concludes that bivalent original\/Omicron BA.4-5 mRNA vaccines may be used for primary vaccination<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/etf-concludes-bivalent-original-omicron-ba4-5-mrna-vaccines-may-be-used-primary-vaccination\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-06-12-2022\/\">Press release<\/a><div class=\"content\"><p><strong>06.12.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nETF statement on the use of the EMA approved bivalent original\/Omicron BA.4-5 mRNA vaccines for primary series<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/other\/etf-statement-use-ema-approved-bivalent-original\/omicron-ba4-5-mrna-vaccines-primary-series_en.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-02-12-2022-2\/\">Press release<\/a><div class=\"content\"><p><strong>02.12.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nMeeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 November &#8211; 1 December 2022<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-28-november-1-december-2022\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-02-12-2022\/\">Press release<\/a><div class=\"content\"><p><strong>02.12.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA recommends withdrawal of pholcodine medicines from EU market<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-recommends-withdrawal-pholcodine-medicines-eu-market\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-30-11-2022\/\">Press release<\/a><div class=\"content\"><p><strong>30.11.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nStatus update: Implementation of the Clinical Trials Regulation<br \/>\n<a href=\"https:\/\/euclinicaltrials.eu\/about-this-website\/#about-main\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-11-11-2022-2\/\">Press release<\/a><div class=\"content\"><p><strong>11.11.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA confirms measures to minimise risk of serious side\u00a0effects with Janus kinase inhibitors for chronic\u00a0inflammatory disorders<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/referral\/janus-kinase-inhibitors-jaki-article-20-referral-ema-confirms-measures-minimise-risk-serious-side_en-0.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-11-11-2022\/\">Press release<\/a><div class=\"content\"><p><strong>11.11.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA confirms recommendation to withdraw marketing\u00a0authorisations for amfepramone medicines<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/referral\/amfepramone-containing-medicinal-products-article-31-referral-ema-confirms-recommendation-withdraw_en.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-10-11-2022\/\">Press release<\/a><div class=\"content\"><p><strong>10.11.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA recommends approval of VidPrevtyn Beta as a COVID 19 booster vaccine<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-recommends-approval-vidprevtyn-beta-covid-19-booster-vaccine\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-28-10-2022-2\/\">Press release<\/a><div class=\"content\"><p><strong>28.10.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA recommends measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/referral\/janus-kinase-inhibitors-jaki-article-20-referral-ema-recommends-measures-minimise-risk-serious-side_en.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-28-10-2022\/\">Press release<\/a><div class=\"content\"><p><strong>28.10.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/referral\/amfepramone-containing-medicinal-products-article-31-referral-ema-recommends-withdrawal-marketing_en.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-30-09-2022\/\">Press release<\/a><div class=\"content\"><p><strong>30.09.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nNew recommendations for terlipressin-containing medicines in the treatment of hepatorenal syndrome<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/new-recommendations-terlipressin-containing-medicines-treatment-hepatorenal-syndrome\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-12-09-2022\/\">Press release<\/a><div class=\"content\"><p><strong>12.09.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nAdapted vaccine targeting BA.4 and BA.5 Omicron variants and original SARS-CoV-2 recommended for approval<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/adapted-vaccine-targeting-ba4-ba5-omicron-variants-original-sars-cov-2-recommended-approval\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-02-09-2022-3\/\">Press release<\/a><div class=\"content\"><p><strong>02.09.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nPRAC starts review of topiramate use in pregnancy and women of childbearing potential<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/prac-starts-review-topiramate-use-pregnancy-women-childbearing-potential\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-02-09-2022-2\/\">Press release<\/a><div class=\"content\"><p><strong>02.09.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nReview of pholcodine medicines started<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/review-pholcodine-medicines-started\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-02-09-2022\/\">Press release<\/a><div class=\"content\"><p><strong>07.03.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nNew measures to minimise risk of meningioma with medicines containing nomegestrol or chlormadinone<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/new-measures-minimise-risk-meningioma-medicines-containing-nomegestrol-chlormadinone\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-2\/\">Press release<\/a><div class=\"content\"><p><strong>03.08.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nCOVID-19 vaccines safety update<br \/>\n<a href=\"\/\/www.ema.europa.eu\/\" target=\"_blank\" rel=\"noopener noreferrer\">descarc\u0103 documentul &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-12-07-2022\/\">Press release<\/a><div class=\"content\"><p><strong>12.07.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nUpdated joint statement from ECDC and EMA on additional booster doses of COVID-19 vaccines<br \/>\n<a href=\"\/en\/_\/COMUNICATE DE PRESA\/ECDC-EMA Statement Vaccine Fourth Dose.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-08-07-2022\/\">Press release<\/a><div class=\"content\"><p><strong>08.07.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nMedicines containing nomegestrol or chlormadinone: PRAC recommends new measures to minimise risk of meningioma<br \/>\n<a href=\"\/en\/_\/COMUNICATE DE PRESA\/Nomegestrol chlormadinone products_art 31 outcome.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-10-06-2022\/\">Press release<\/a><div class=\"content\"><p><strong>10.06.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA recommends withdrawal of marketing authorisation for amfepramone medicines<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-recommends-withdrawal-marketing-authorisation-amfepramone-medicines\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-06-05-2022\/\">Press release<\/a><div class=\"content\"><p><strong>06.05.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nMeeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 May 2022<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-2-5-may-2022\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-12-04-2022\/\">Press release<\/a><div class=\"content\"><p><strong>12.04.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nTHE NAMMDR encourages the reporting of adverse effects of medicines for human use and vaccines by citizens coming from Ukraine to Romania, through healthcare professionals<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/COMUNICATE DE PRESA\/flyer ANMDMR - side effects reporting_Ukraina - 4 pagini.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-08-04-2022\/\">Press release<\/a><div class=\"content\"><p><strong>08.04.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nMeeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4 \u2013 7 April 2022<br \/>\n<a href=\"https:\/\/www.anm.ro\/en\/_\/COMUNICATE DE PRESA\/Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4 \u2013 7 April 2022.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-07-03-2022-2\/\">Press release<\/a><div class=\"content\"><p><strong>07.03.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nECDC and EMA issue advice on fourth doses of mRNA COVID-19 vaccines<br \/>\n<a href=\"\/en\/_\/COMUNICATE DE PRESA\/ECDC and EMA issue advice on fourth doses of mRNA COVID-19 vaccines.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-07-03-2022\/\">Press release<\/a><div class=\"content\"><p><strong>07.03.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nCOVID-19: Joint statement from ECDC and EMA on the administration of a fourth dose of mRNA vaccines<br \/>\n<a href=\"\/en\/_\/COMUNICATE DE PRESA\/COVID-19-Joint statement from ECDC and EMA on the administration of a fourth dose of mRNA vaccines.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-11-03-2022\/\">Press release<\/a><div class=\"content\"><p><strong>11.03.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nMeeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 March 2022<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-7-10-march-2022\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-02-03-2022\/\">Press release<\/a><div class=\"content\"><p><strong>02.03.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nStarting with Tuesday, 1 March 2022, Mr. R\u0103zvan Mihai Prisada is the new president of the National Agency for Medicines and Medical Devices of Romania, following promotion of the competition organised by the Ministry of Health for filling the vacant management position for an indefinite period.<br \/>\nR\u0103zvan Mihai Prisada is a pharmacist and a Doctor of Pharmacy and has occupied the position of Vice President of the Romanian College of Pharmacists since 2016.<br \/>\nIn 2019, having extensive experience in the pharmaceutical field and in national and European medicinal product policies, R\u0103zvan Mihai Prisada coordinated, as chair, the activity of the Working Group on Pharmaceuticals and Medical Devices within the Council of the European Union.<br \/>\n\u201cThis is a time when the Agency, through its essential role in the Romanian healthcare system and at European level, together with the other national agencies, must ensure efficient management of medicinal products and medical devices on the Romanian market. Particularly in the context of the global crisis we are all experiencing, patients\u2019 right to access to appropriate medical treatment is mandatory, and healthcare institutions must assess the risks and find effective solutions as soon as possible. There are many things that need to be put back on a normal track, so that the institution regains its prestige and its specialists are valued once again&#8221;, says R\u0103zvan Mihai Prisada, the new president of the NAMMDR.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-01-03-2022\/\">Press release<\/a><div class=\"content\"><p><strong>01.03.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nRegulation on EMA\u2019s extended mandate becomes applicable<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/regulation-emas-extended-mandate-becomes-applicable\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-24-02-2022\/\">Press release<\/a><div class=\"content\"><p><strong>24.02.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA recommends approval of Spikevax for children aged 6 to 11<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-recommends-approval-spikevax-children-aged-6-11\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-28-01-2022\/\">Press release<\/a><div class=\"content\"><p><strong>28.01.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nStart of a review concerning the conduct of studies at Synchron Research Services, India<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/referral\/synchron-article-31-referral-review-started_en.pdf\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-27-01-2022\/\">Press release<\/a><div class=\"content\"><p><strong>27.01.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nCOVID-19: EMA recommends conditional marketing authorisation for Paxlovid<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/covid-19-ema-recommends-conditional-marketing-authorisation-paxlovid\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-14-01-2022\/\">Press release<\/a><div class=\"content\"><p><strong>14.01.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nMeeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 &#8211; 13 January 2022<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-10-13-january-2022\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-11-01-2022\/\">Press release<\/a><div class=\"content\"><p><strong>11.01.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nPreliminary data indicate COVID-19 vaccines remain effective against severe disease and hospitalisation caused by the Omicron variant<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/preliminary-data-indicate-covid-19-vaccines-remain-effective-against-severe-disease-hospitalisation\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-10-01-2022\/\">Press release<\/a><div class=\"content\"><p><strong>10.01.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA receives application for conditional marketing authorisation for Paxlovid (PF-07321332 and ritonavir) for treating patients with COVID-19<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-receives-application-conditional-marketing-authorisation-paxlovid-pf-07321332-ritonavir-treating\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-17-12-2021\/\">Press release<\/a><div class=\"content\"><p><strong>17.12.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nMeeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 2021<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-committee-medicinal-products-human-use-chmp-13-16-december-2021\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-20-12-2021\/\">Press release<\/a><div class=\"content\"><p><strong>20.12.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nNuvaxovid &#8211; COVID-19 Vaccine (recombinant, adjuvanted)<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/nuvaxovid\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-16-12-2021\/\">Press release<\/a><div class=\"content\"><p><strong>16.12.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA recommends approval for use of Kineret in adults with COVID-19<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-recommends-approval-use-kineret-adults-covid-19\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-13-12-2021\/\">Press release<\/a><div class=\"content\"><p><strong>13.12.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nHealth Technology Assessment: Commission welcomes the adoption of new rules to improve access to innovative technologies<br \/>\n<a href=\"https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/ip_21_6771\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-07-12-2021\/\">Press release<\/a><div class=\"content\"><p><strong>07.12.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA and ECDC recommendations on heterologous vaccination courses against COVID-19<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-ecdc-recommendations-heterologous-vaccination-courses-against-covid-19\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-06-12-2021\/\">Press release<\/a><div class=\"content\"><p><strong>06.12.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA recommends approval for use of RoActemra in adults with severe COVID-19<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-recommends-approval-use-roactemra-adults-severe-covid-19\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-03-12-2021\/\">Press release<\/a><div class=\"content\"><p><strong>03.12.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nMeeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 November &#8211; 2 December 2021.<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-29-november-2-december-2021\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-25-11-2021\/\">Press release<\/a><div class=\"content\"><p><strong>25.11.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nComirnaty COVID-19 vaccine: EMA recommends approval for children aged 5 to 11<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/comirnaty-covid-19-vaccine-ema-recommends-approval-children-aged-5-11\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-23-11-2021\/\">Press release<\/a><div class=\"content\"><p><strong>23.11.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA receives application for marketing authorisation for Lagevrio (molnupiravir) for treating patients with COVID-19<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-receives-application-marketing-authorisation-lagevrio-molnupiravir-treating-patients-covid-19\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-22-11-2021\/\">Press release<\/a><div class=\"content\"><p><strong>22.11.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA evaluating data on booster dose of COVID-19 Vaccine Janssen<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-evaluating-data-booster-dose-covid-19-vaccine-janssen\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-19-11-2021\/\">Press release<\/a><div class=\"content\"><p><strong>19.11.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA starts review of Paxlovid for treating patients with COVID-19<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-starts-review-paxlovid-treating-patients-covid-19\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-18-11-2021\/\">Press release<\/a><div class=\"content\"><p><strong>18.11.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA receives application for marketing authorisation for Xevudy (sotrovimab) for treating patients with COVID-19<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-receives-application-marketing-authorisation-xevudy-sotrovimab-treating-patients-covid-19\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-17-11-2021\/\">Press release<\/a><div class=\"content\"><p><strong>17.11.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA receives application for conditional marketing authorisation of Novavax\u2019s COVID-19 vaccine, Nuvaxovid<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-receives-application-conditional-marketing-authorisation-novavaxs-covid-19-vaccine-nuvaxovid\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-10-11-2021\/\">Press release<\/a><div class=\"content\"><p><strong>10.11.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA starts evaluating use of COVID-19 vaccine Spikevax in children aged 6 to 11<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-starts-evaluating-use-covid-19-vaccine-spikevax-children-aged-6-11\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-08-11-2021\/\">Press release<\/a><div class=\"content\"><p><strong>08.11.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nCOVID-19: EMA and Heads of Medicines Agencies update on molnupiravir; EMA starts review to support possible national decisions on early use<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/covid-19-ema-heads-medicines-agencies-update-molnupiravir\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-02-11-2021-2\/\">Press release<\/a><div class=\"content\"><p><strong>02.11.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA ends rolling review of the antibodies bamlanivimab and etesevimab for COVID-19 following withdrawal by Lilly<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-ends-rolling-review-antibodies-bamlanivimab-etesevimab-covid-19-following-withdrawal-lilly\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-02-11-2021\/\">Press release<\/a><div class=\"content\"><p><strong>02.11.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nQuestions and answers on end of rolling review for antibodies bamlanivimab and etesevimab for COVID-19.<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/medicine-qa\/questions-answers-end-rolling-review-antibodies-bamlanivimab-etesevimab-covid-19_en.pdf\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-29-10-2021\/\">Press release<\/a><div class=\"content\"><p><strong>29.10.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nMeeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 October 2021<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-25-28-october-2021\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-25-10-2021-2\/\">Press release<\/a><div class=\"content\"><p><strong>25.10.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nSpikevax: EMA recommendation on booster<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/spikevax-ema-recommendation-booster\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-25-10-2021\/\">Press release<\/a><div class=\"content\"><p><strong>25.10.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nCOVID-19: EMA starts rolling review of molnupiravir<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/covid-19-ema-starts-rolling-review-molnupiravir\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-12-10-2021-2\/\">Press release<\/a><div class=\"content\"><p><strong>12.10.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nQuestions and answers on end of rolling review for CureVac\u2019s COVID-19 vaccine (CVnCoV)<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/medicine-qa\/questions-answers-end-rolling-review-curevacs-covid-19-vaccine-cvncov_en.pdf\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-14-10-2021\/\">Press release<\/a><div class=\"content\"><p><strong>14.10.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA starts rolling review of Evusheld (tixagevimab and cilgavimab)<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-starts-rolling-review-evusheld-tixagevimab-cilgavimab\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-12-10-2021\/\">Press release<\/a><div class=\"content\"><p><strong>12.10.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA ends rolling review of CVnCoV COVID-19 vaccine following withdrawal by CureVac AG<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-ends-rolling-review-cvncov-covid-19-vaccine-following-withdrawal-curevac-ag\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-11-10-2021\/\">Press release<\/a><div class=\"content\"><p><strong>11.10.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA receives application for marketing authorisation for Ronapreve (casirivimab \/ imdevimab) for treatment and prevention of COVID-19<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-receives-application-marketing-authorisation-ronapreve-casirivimab-imdevimab-treatment\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-07-10-2021\/\">Press release<\/a><div class=\"content\"><p><strong>07.10.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nAdditional manufacturing site for COVID-19 Vaccine Janssen<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/additional-manufacturing-site-covid-19-vaccine-janssen-0\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-04-10-2021-2\/\">Press release<\/a><div class=\"content\"><p><strong>04.10.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nComirnaty and Spikevax: EMA recommendations on extra doses and boosters<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/comirnaty-spikevax-ema-recommendations-extra-doses-boosters\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-04-10-2021\/\">Press release<\/a><div class=\"content\"><p><strong>04.10.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA receives application for marketing authorisation for Regkirona (regdanvimab) for treating patients with COVID-19<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-receives-application-marketing-authorisation-regkirona-regdanvimab-treating-patients-covid-19\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-01-10-2021-2\/\">Press release<\/a><div class=\"content\"><p><strong>01.10.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nMeeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 September 2021<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-27-30-september-2021\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-01-10-2021\/\">Press release<\/a><div class=\"content\"><p><strong>01.10.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA starts review of meningioma risk with nomegestrol- and chlormadinone-containing medicines<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-starts-review-meningioma-risk-nomegestrol-chlormadinone-containing-medicines\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-27-09-2021\/\">Press release<\/a><div class=\"content\"><p><strong>27.09.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA evaluating data on booster dose of COVID-19 vaccine Spikevax<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-evaluating-data-booster-dose-covid-19-vaccine-spikevax\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-09-09-2021\/\">Press release<\/a><div class=\"content\"><p><strong>09.09.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nIncrease in manufacturing capacity for COVID-19 vaccine from BioNTech\/Pfizer<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/increase-manufacturing-capacity-covid-19-vaccine-biontechpfizer\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-06-09-2021\/\">Press release<\/a><div class=\"content\"><p><strong>06.09.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA evaluating data on booster dose of COVID-19 vaccine Comirnaty.<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-evaluating-data-booster-dose-covid-19-vaccine-comirnaty\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-03-09-2021\/\">Press release<\/a><div class=\"content\"><p><strong>03.09.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nShortage of RoActemra (tocilizumab)<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/shortage\/roactemra-tocilizumab-supply-shortage_en.pdf\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-02-09-2021\/\">Press release<\/a><div class=\"content\"><p><strong>02.09.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nECDC and EMA highlight considerations for additional and booster doses of COVID-19 vaccines<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ecdc-ema-highlight-considerations-additional-booster-doses-covid-19-vaccines\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-24-08-2021\/\">Press release<\/a><div class=\"content\"><p><strong>24.08.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nIncrease in vaccine manufacturing capacity for COVID-19 vaccines from BioNTech \/ Pfizer and Moderna<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/increase-vaccine-manufacturing-capacity-covid-19-vaccines-biontech-pfizer-moderna\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-06-08-2021\/\">Press release<\/a><div class=\"content\"><p><strong>06.08.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nMeeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 August 2021<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-5-august-2021\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-04-08-2021\/\">Press release<\/a><div class=\"content\"><p><strong>04.08.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nECDC and EMA update on COVID-19: Full vaccination is key to protecting against serious COVID-19, including disease caused by the Delta variant<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ecdc-ema-update-covid-19\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-23-07-2021\/\">Press release<\/a><div class=\"content\"><p><strong>23.07.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nCOVID-19 vaccine Spikevax approved for children aged 12 to 17 in EU<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/covid-19-vaccine-spikevax-approved-children-aged-12-17-eu\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-22-07-2021\/\">Press release<\/a><div class=\"content\"><p><strong>22.07.2021 <\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nCOVID-19 Vaccine Janssen: Guillain-Barr\u00e9 syndrome listed as a very rare side effect<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/covid-19-vaccine-janssen-guillain-barre-syndrome-listed-very-rare-side-effect\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-20-07-2021\/\">Press release<\/a><div class=\"content\"><p><strong>20.07.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA starts rolling review of COVID-19 vaccine Vidprevtyn<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-starts-rolling-review-covid-19-vaccine-vidprevtyn\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-19-07-2021\/\">Press release<\/a><div class=\"content\"><p><strong>19.07.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA starts evaluating the use of Kineret in adult COVID-19 patients at increased risk of severe respiratory failure<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-starts-evaluating-use-kineret-adult-covid-19-patients-increased-risk-severe-respiratory-failure\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-09-07-2021-3\/\">Press release<\/a><div class=\"content\"><p><strong>09.07.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA finds no evidence linking viral vector in Zynteglo to blood cancer.<br \/>\n<a href=\"\/en\/_\/COMUNICATE DE PRESA\/EMA finds no evidence linking viral vector in Zynteglo to blood cancer.pdf\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-09-07-2021-2\/\">Press release<\/a><div class=\"content\"><p><strong>09.07.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA advises against use of COVID-19 Vaccine Janssen in people with history of capillary leak syndrome.<br \/>\n<a href=\"\/en\/_\/COMUNICATE DE PRESA\/EMA advises against use of COVID-19 Vaccine Janssen in people with history of capillary leak syndrome.pdf\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-09-07-2021\/\">Press release<\/a><div class=\"content\"><p><strong>09.07.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nComirnaty and Spikevax: possible link to very rare cases of myocarditis and pericarditis.<br \/>\n<a href=\"\/en\/_\/COMUNICATE DE PRESA\/Comirnaty and Spikevax - possible link to very rare cases of myocarditis and pericarditis.pdf\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-11-06-2021-3\/\">Press release<\/a><div class=\"content\"><p><strong>11.06.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nCOVID-19 Vaccine Janssen: authorities in EU take steps to safeguard vaccine quality<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/covid-19-vaccine-janssen-authorities-eu-take-steps-safeguard-vaccine-quality\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-11-06-2021-2\/\">Press release<\/a><div class=\"content\"><p><strong>11.06.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nCOVID-19 vaccines: update on ongoing evaluation of myocarditis and pericarditis.<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/covid-19-vaccines-update-ongoing-evaluation-myocarditis-pericarditis\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-11-06-2021\/\">Press release<\/a><div class=\"content\"><p><strong>11.06.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nVaxzevria: EMA advises against use in people with history of capillary leak syndrome<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/vaxzevria-ema-advises-against-use-people-history-capillary-leak-syndrome\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-08-06-2021\/\">Press release<\/a><div class=\"content\"><p><strong>08.06.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA evaluating the use of COVID-19 Vaccine Moderna in young people aged 12 to 17<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-evaluating-use-covid-19-vaccine-moderna-young-people-aged-12-17\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-07-06-2021\/\">Press release<\/a><div class=\"content\"><p><strong>07.06.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA raises awareness of clinical care recommendations to manage suspected thrombosis with thrombocytopenia syndrome.<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-raises-awareness-clinical-care-recommendations-manage-suspected-thrombosis-thrombocytopenia\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-01-06-2021\/\">Press release<\/a><div class=\"content\"><p><strong>01.06.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nAdditional manufacturing capacity for BioNTech\/Pfizer\u2019s COVID-19 vaccine.<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/additional-manufacturing-capacity-biontechpfizers-covid-19-vaccine\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-28-05-2021\/\">Press release<\/a><div class=\"content\"><p><strong>28.05.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nFirst COVID-19 vaccine approved for children aged 12 to 15 in EU.<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/first-covid-19-vaccine-approved-children-aged-12-15-eu\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-27-05-2021\/\">Press release<\/a><div class=\"content\"><p><strong>27.05.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nInsufficient data on use of inhaled corticosteroids to treat COVID-19<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/insufficient-data-use-inhaled-corticosteroids-treat-covid-19\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-21-05-2021-2\/\">Press release<\/a><div class=\"content\"><p><strong>21.05.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA issues advice on use of sotrovimab (VIR-7831) for treating COVID-19.<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-issues-advice-use-sotrovimab-vir-7831-treating-covid-19\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-21-05-2021\/\">Press release<\/a><div class=\"content\"><p><strong>21.05.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nVaxzevria: further advice on blood clots and low blood platelets.<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/vaxzevria-further-advice-blood-clots-low-blood-platelets\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-07-05-2021-2\/\">Press release<\/a><div class=\"content\"><p><strong>07.05.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nMeeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 May 2021.<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-3-6-may-2021\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-07-05-2021\/\">Press release<\/a><div class=\"content\"><p><strong>07.05.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA starts rolling review of sotrovimab (VIR-7831) for COVID-19.<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-starts-rolling-review-sotrovimab-vir-7831-covid-19\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-04-05-2021\/\">Press release<\/a><div class=\"content\"><p><strong>04.05.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA starts evaluating use of Olumiant in hospitalised COVID-19 patients requiring supplemental oxygen.<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-starts-evaluating-use-olumiant-hospitalised-covid-19-patients-requiring-supplemental-oxygen\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-28-04-2021-2\/\">Press release<\/a><div class=\"content\"><p><strong>28.04.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nAstraZeneca\u2019s COVID-19 vaccine: benefits and risks in context.<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/astrazenecas-covid-19-vaccine-benefits-risks-context\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-28-04-2021\/\">Press release<\/a><div class=\"content\"><p><strong>28.04.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nAnnex to Vaxzevria Art.5.3 &#8211; Visual risk contextualisation.<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/chmp-annex\/annex-vaxzevria-art53-visual-risk-contextualisation_en.pdf\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-21-04-2021\/\">Press release<\/a><div class=\"content\"><p><strong>21.04.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nCOVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets:<br \/>\nEMA confirms overall benefit-risk remains positive.<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/covid-19-vaccine-janssen-ema-finds-possible-link-very-rare-cases-unusual-blood-clots-low-blood\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-15-04-2021-2\/\">Press release<\/a><div class=\"content\"><p><strong>15.04.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nCOVID-19 Vaccine Janssen: assessment of very rare cases of unusual blood clots with low platelets continues.<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/covid-19-vaccine-janssen-assessment-very-rare-cases-unusual-blood-clots-low-platelets-continues\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-15-04-2021\/\">Press release<\/a><div class=\"content\"><p><strong>15.04.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nAstraZeneca\u2019s COVID-19 vaccine: EMA to provide further context on risk of very rare blood clots with low blood platelets.<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/astrazenecas-covid-19-vaccine-ema-provide-further-context-risk-very-rare-blood-clots-low-blood\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-09-04-2021\/\">Press release<\/a><div class=\"content\"><p><strong>09.04.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nMeeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 April 2021<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-6-9-april-2021\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-07-04-2021\/\">Press release<\/a><div class=\"content\"><p><strong>07.04.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nAstraZeneca\u2019s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/astrazenecas-covid-19-vaccine-ema-finds-possible-link-very-rare-cases-unusual-blood-clots-low-blood\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-31-03-2021\/\">Press release<\/a><div class=\"content\"><p><strong>31.03.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nAstraZeneca COVID-19 vaccine: review of very rare cases of unusual blood clots continues<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/astrazeneca-covid-19-vaccine-review-very-rare-cases-unusual-blood-clots-continues\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-25-03-2021\/\">Press release<\/a><div class=\"content\"><p><strong>25.03.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: COVID-19 Vaccine AstraZeneca \u2013 Update on ongoing evaluation of blood clot cases<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/covid-19-vaccine-astrazeneca-update-ongoing-evaluation-blood-clot-cases\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-22-03-2021\/\">Press release<\/a><div class=\"content\"><p><strong>22.03.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: EMA advises against use of ivermectin for the prevention or treatment of COVID-19 outside randomised clinical trials.<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-advises-against-use-ivermectin-prevention-treatment-covid-19-outside-randomised-clinical-trials\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-18-03-2021\/\">Press release<\/a><div class=\"content\"><p><strong>18.03.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: COVID-19 Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to rare blood clots with low blood platelets<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/covid-19-vaccine-astrazeneca-benefits-still-outweigh-risks-despite-possible-link-rare-blood-clots\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-15-03-2021-2\/\">Press release<\/a><div class=\"content\"><p><strong>15.03.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: Review of thalassaemia medicine Zynteglo started.<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/referrals\/zynteglo\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-15-03-2021\/\">Press release<\/a><div class=\"content\"><p><strong>15.03.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: EMA\u2019s safety committee continues investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events \u2013 further update<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/emas-safety-committee-continues-investigation-covid-19-vaccine-astrazeneca-thromboembolic-events\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-11-03-2021-5\/\">Press release<\/a><div class=\"content\"><p><strong>11.03.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: EMA recommends COVID-19 Vaccine Janssen for authorisation in the EU.<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-recommends-covid-19-vaccine-janssen-authorisation-eu\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-11-03-2021-4\/\">Press release<\/a><div class=\"content\"><p><strong>11.03.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: COVID-19 Vaccine Janssen (COVID-19 vaccine (Ad26.COV2-S [recombinant])).<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/smop-initial\/chmp-summary-positive-opinion-covid-19-vaccine-janssen_en.pdf\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-11-03-2021-3\/\">Press release<\/a><div class=\"content\"><p><strong>11.03.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: EMA starts rolling review of Eli Lilly antibodies bamlanivimab and etesemivab for COVID-19.<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-starts-rolling-review-eli-lilly-antibodies-bamlanivimab-etesemivab-covid-19\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-11-03-2021-2\/\">Press release<\/a><div class=\"content\"><p><strong>11.03.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: COVID-19 Vaccine AstraZeneca: PRAC preliminary view suggests no specific issue with batch used in Austria (ABV5300) \u2013 Batch number ABV5300 of COVID-19 Vaccine AstraZeneca has not been distributed in Romania.<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/covid-19-vaccine-astrazeneca-prac-preliminary-view-suggests-no-specific-issue-batch-used-austria\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-11-03-2021\/\">Press release<\/a><div class=\"content\"><p><strong>11.03.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: Reflection paper on the regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2.<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/reflection-paper-regulatory-requirements-vaccines-intended-provide-protection-against-variant_en.pdf\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-04-03-2021-2\/\">Press release<\/a><div class=\"content\"><p><strong>04.03.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: EMA review of regdanvimab for COVID-19 to support national decisions on early use<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-review-regdanvimab-covid-19-support-national-decisions-early-use\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-08-03-2021\/\">Press release<\/a><div class=\"content\"><p><strong>08.03.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: EMA issues advice on use of antibody combination (bamlanivimab \/ etesevimab)<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-issues-advice-use-antibody-combination-bamlanivimab-etesevimab\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-04-03-2021-3\/\">Press release<\/a><div class=\"content\"><p><strong>04.03.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: EMA starts rolling review of the Sputnik V COVID-19 vaccine<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-starts-rolling-review-sputnik-v-covid-19-vaccine\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-04-03-2021\/\">Press release<\/a><div class=\"content\"><p><strong>04.03.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nThe NAMMDR took note of the existence in the public space of some statements announcing the intention to conduct a clinical study in Romania in order to investigate the efficacy of ivermectin in preventing and treating the Sars-CoV-2 infection.<br \/>\nThe NAMMDR states that, so far, no application has been submitted for authorisation of a clinical trial for investigation of ivermectin.<br \/>\nPlease note that, in Romania, according to the provisions of Article 7011 of Law no. 95\/2006 on healthcare reform, republished, as amended, the NAMMDR authorises and controls clinical trials with medicinal products for human use by assessing compliance with good practices in clinical trials with or without therapeutic benefit, as well as the clinical trial site.<br \/>\nThus, clinical trials are conducted in compliance with the principles and detailed guidelines on good clinical practice, the Rules on the implementation of good clinical practice rules conducted with medicinal products for human use approved by Order of the Minister of Health no. 904\/2006 for approval of Norms relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use and Scientific Council Decision no.2 \/ 22.04.2014 on approval of Regulations for authorisation of sites for conduct of clinical trials on medicinal products for human use \u2013 as amended through Scientific Council Decision no. 24\/03.07.2015.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-03-03-2021\/\">Press release<\/a><div class=\"content\"><p><strong>03.03.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: Adapting COVID-19 vaccines to SARS-CoV-2 variants: guidance for vaccine manufacturers<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/adapting-covid-19-vaccines-sars-cov-2-variants-guidance-vaccine-manufacturers\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-23-02-2021-2\/\">Press release<\/a><div class=\"content\"><p><strong>23.02.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: EMA starts evaluating use of Veklury in COVID-19 patients not requiring supplemental oxygen<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-starts-evaluating-use-veklury-covid-19-patients-not-requiring-supplemental-oxygen\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-23-02-2021\/\">Press release<\/a><div class=\"content\"><p><strong>23.02.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: Precautionary marketing suspension of thalassaemia medicine Zynteglo<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/precautionary-marketing-suspension-thalassaemia-medicine-zynteglo\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-18-02-2021\/\">Press release<\/a><div class=\"content\"><p><strong>18.02.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: EMA receives application for conditional marketing authorisation of COVID-19 Vaccine Janssen<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-receives-application-conditional-marketing-authorisation-covid-19-vaccine-janssen\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-16-02-2021\/\">Press release<\/a><div class=\"content\"><p><strong>16.02.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: Review of amfepramone medicines started<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/referral\/amfepramone-containing-medicinal-products-article-31-referral-review-started_en.pdf\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-12-02-2021\/\">Press release<\/a><div class=\"content\"><p><strong>12.02.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: EMA starts rolling review of CureVac\u2019s COVID-19 vaccine (CVnCoV)<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-starts-rolling-review-curevacs-covid-19-vaccine-cvncov\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-11-02-2021\/\">Press release<\/a><div class=\"content\"><p><strong>11.02.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: Clarification on Sputnik V vaccine in the EU approval process<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/clarification-sputnik-v-vaccine-eu-approval-process\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-08-02-2021-2\/\">Press release<\/a><div class=\"content\"><p><strong>08.02.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: EMA reviewing data on monoclonal antibody use for COVID-19<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-reviewing-data-monoclonal-antibody-use-covid-19\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-08-02-2021\/\">Press release<\/a><div class=\"content\"><p><strong>08.02.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: COVID-19 Vaccine AstraZeneca<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/smop-initial\/chmp-summary-positive-opinion-covid-19-vaccine-astrazeneca_en.pdf\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-05-02-2021-2\/\">Press release<\/a><div class=\"content\"><p><strong>05.02.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: EMA recommends COVID-19 Vaccine AstraZeneca for authorisation in the EU<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-recommends-covid-19-vaccine-astrazeneca-authorisation-eu\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-05-02-2021\/\">Press release<\/a><div class=\"content\"><p><strong>05.02.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: EMA starts rolling review of Novavax\u2019s COVID-19 vaccine (NVX-CoV2373)<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-starts-rolling-review-novavaxs-covid-19-vaccine-nvx-cov2373\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-02-02-2021-3\/\">Press release<\/a><div class=\"content\"><p><strong>02.02.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: EMA starts rolling review of REGN-COV2 antibody combination (casirivimab \/ imdevimab)<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-starts-rolling-review-regn-cov2-antibody-combination-casirivimab-imdevimab\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-02-02-2021-2\/\">Press release<\/a><div class=\"content\"><p><strong>02.02.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: First COVID-19 vaccine safety update published<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/first-covid-19-vaccine-safety-update-published\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-02-02-2021\/\">Press release<\/a><div class=\"content\"><p><strong>02.02.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: COVID-19 vaccine safety update (COMIRNATY BioNTech Manufacturing GmbH)<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/covid-19-vaccine-safety-update\/covid-19-vaccine-safety-update-comirnaty-january-2021_en.pdf\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-01-02-2021\/\">Press release<\/a><div class=\"content\"><p><strong>01.02.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: Clarification of Comirnaty dosage interval<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/clarification-comirnaty-dosage-interval\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-29-01-2021\/\">Press release<\/a><div class=\"content\"><p><strong>29.01.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\n<strong>Notice on administration of ivermectin as prophylaxis and treatment in Covid-19<\/strong><br \/>\nFollowing the information published in the media concerning the use of ivermectin as prophylaxis and treatment in Covid-19, the NAMMDR makes the following clarifications:<br \/>\n1. Ivermectin is an antiparasitic chemotherapy medicinal product, being used in the treatment of parasitic diseases in both veterinary and human medicine. It is similarly used in the treatment of parasitic skin diseases, scabies and pediculosis included.<br \/>\n2. In Romania, only one medicinal product for human use is approved, containing ivermectin, namely a cream administered in rosacea.<br \/>\n3. There are several medicinal products containing ivermectin for antiparasitic indications as well as for rosacea, available in Europe.<br \/>\n4. Several controlled clinical trials are currently being conducted, both in Europe and globally, including patients with COVID-19 or their contacts in order to demonstrate possible benefits in this condition. Based on in vitro studies which have shown that ivermectin has an anti-inflammatory and antiviral effect, these in vivo studies in humans have been designed and are available online at: <a href=\"https:\/\/clinicaltrials.gov\/\" target=\"_blank\" rel=\"noopener\">https:\/\/clinicaltrials.gov\/<\/a>.<br \/>\n5. In the most recent protocol for treatment of the SARS-CoV-2 infection (Order of the Ministry of Health No. 2054 of 27 November 2020, published in the Official Gazette no. 1167\/3 December 2020 amending the Annex to Order of the Minister of Health no. 487 \/ 2020), ivermectin is not mentioned as an effective mediicnal product in this disease.<br \/>\nPatients are thus advised not to use ivermectin outside of therapeutic indications, since no final data on its efficacy in Covid-19 is currently available.<br \/>\n6. So far, the NAMMDR has not received any request for assessment in order to approve the conduct of clinical trials with ivermectin in Romania.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-19-01-2021\/\">Press release<\/a><div class=\"content\"><p><strong>19.01.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\n<strong>Appointment of a new NAMMD President<\/strong><br \/>\nStarting today, 19 January 2021, Ms. Roxana Stroe regains the status of President of the National Agency for Medicines and Medical Devices. Ms. Roxana Stroe, MD, is a Senior Physician in Clinical Pharmacology and has been working for the NAMMD for 11 years. Since 2014, she has been a member of the European Medicines Agency\u2019s (EMA) Pharmacovigilance Risk Assessment Committee. She has been Coordinator of the Agency\u2019s Pharmacovigilance and Risk Management Directorate, being actively involved, together with the Agency\u2019s and the Ministry of Health\u2019s team, in the actions organised on the occasion of Romania&#8217;s mandate at the presidency of the Council of the European Union.<br \/>\n\u201cThe Covid-19 pandemic is a difficult period for all of us, but together with the Ministry of Health, the NAMMDR team of professionals will continue to promptly address the inherent challenges in the pandemic and provide fast and efficient solutions for the benefit of the Romanian patient. The Agency&#8217;s experts are an active part of the most important EMA working groups and contribute to the implementation of the European strategy for handling the crisis caused by the SARS-Cov-2 virus.&#8221;<br \/>\nEnlarging the team of experts, increasing the degree of transparency of activities carried out in a professional manner, contributing, together with the Ministry of Health, the National Health Insurance House (NHIH) and other relevant institutions to various projects in order to increase patients&#8217; access to medicinal products are some of the immediate objectives of the new President, Ms. Stroe.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-12-01-2021\/\">Press release<\/a><div class=\"content\"><p><strong>12.01.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-receives-application-conditional-marketing-authorisation-covid-19-vaccine-astrazeneca\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-08-01-2021-2\/\">Press release<\/a><div class=\"content\"><p><strong>08.01.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: EMA recommends COVID-19 Vaccine Moderna for authorisation in the EU<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-recommends-covid-19-vaccine-moderna-authorisation-eu\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-08-01-2021\/\">Press release<\/a><div class=\"content\"><p><strong>08.01.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: COVID-19 Vaccine Moderna<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/covid-19-vaccine-moderna\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-06-01-2021\/\">Press release<\/a><div class=\"content\"><p><strong>06.01.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: Update on rolling review of AstraZeneca\u2019s COVID-19 vaccine<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/update-rolling-review-astrazenecas-covid-19-vaccine\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-05-01-2021\/\">Press release<\/a><div class=\"content\"><p><strong>05.01.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: EMA public stakeholder meeting on COVID-19<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/ANUNTURI%20IMPORTANTE\/EMA%20Public%20stakeholders%20meeting_Agenda.pdf\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/events\/public-stakeholder-meeting-development-authorisation-safe-effective-covid-19-vaccines-eu#event-summary-section\" target=\"_blank\" rel=\"noopener\">download document \u2026<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-16-11-2020\/\">Press release<\/a><div class=\"content\"><p><strong>16.11.2020<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nNitrosamines: EMA aligns recommendations for sartans with those for other medicinal products<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/COMUNICATE%20DE%20PRESA\/Sartans%20press%20release_revised%20AP.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-22-10-2020\/\">Press release<\/a><div class=\"content\"><p><strong>22.10.2020<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEU authorities are investigating the presence of a nitrosamine impurity, 1-Nitroso-4-methyl piperazine (MeNP), in some batches of active substances used in medicinal products containing rifampicin<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/COMUNICATE%20DE%20PRESA\/Comunicat%20de%20presa%20-%20Rifampicina.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-20-10-2020\/\">Press release<\/a><div class=\"content\"><p><strong>20.10.2020<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEU regulators require testing for nitrosamine impurities in metformin-containing medicinal products<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/COMUNICATE%20DE%20PRESA\/Traducere%20comunicat%20de%20presa%20nitrozamine%2016.10.2020.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-09-07-2020\/\">Press release<\/a><div class=\"content\"><p><strong>09.07.2020<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on the finalization of the opinion on the presence of nitrosamine impurities in medicinal products<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/COMUNICATE%20DE%20PRESA\/Nitrozamine_art%205(3).pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-16-01-2020\/\">Press release<\/a><div class=\"content\"><p><strong>16.01.2020<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nFollowing the suspension by the EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINES (EDQM) of Certificates of Suitability (CEP) to the Monographs of the European Pharmacopoeia for the active substance ranitidine hydrochloride, resulting from detection of nitrosamine impurities (NDMA), the National Agency for Medicines and Medical Devices of Romania (ANMDMR) has requested the barring from sale at pharmacy level of pharmaceutical forms for both oral administration and solution for injection of ranitidine containing medicinal products. This is a precautionary measure pending the European Commission decision on ranitidine containing medicines affected by this quality nonconformity.<br \/>\nIn this respect, the NAMMDR has requested Marketing Authorisation Holders for these medicines to submit the following:<br \/>\n\u2013 an evidence of valid manufactured batches currently both held in their own warehouse and already distributed within the pharmaceutical network (warehouses and pharmacies), as well as of the batches manufactured and not yet released for sale;<br \/>\n\u2013 an inventory of distributors to whom the ranitidine containing batches have been distributed and the evidence of their notification on the barring from sale measure;<br \/>\n\u2013 an evidence of the quantities held in their own warehouse of the active substance ranitidine hydrochloride from manufacturers with suspended CEPs.<br \/>\nUnder the circumstances, the NAMMDR advises healthcare professionals on the market availability of alternative treatments and recommends that patients see their doctor in this regard.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-15-01-2020\/\">Press release<\/a><div class=\"content\"><p><strong>15.01.2020<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nMinister of Health Dr. Victor Costache, has appointed Ms. Roxana Stroe, MD, as President of the National Agency for Medicines and Medical Devices of Romania (NAMMDR) as of January 14, 2020.<br \/>\nMs. Roxana Stroe, MD, is a Senior Physician in Clinical Pharmacology She has been working in the Agency since the end of 2010 and has been Coordinator of the Agency\u2019s Pharmacovigilance and Risk Management Directorate. Since 2014, she has been a member of the European Medicines Agency\u2019s (EMA) Pharmacovigilance Risk Assessment Committee, and an alternate member of the EMA\u2019s Management Board since March 2019.<br \/>\nAccording to the appointing Minister of Health Order, Dr. Roxana Stroe\u2019s position as President is temporary, pending the contest for the President position or revocation, according to legislation in force.<br \/>\nThe duties of the newly appointed President are both achievement of objectives within the NAMMDD scope and development of the strategy for transparent and fair conduct of competitions for filling the Agency\u2019s President and Vice President positions, in line with a competition methodology validated by reputable specialists in the field.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-20-12-2019\/\">Press release<\/a><div class=\"content\"><p><strong>20.12.2019<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nQUESTIONS AND ANSWERS regarding the document &#8220;Information on nitrosamines, to the attention of marketing authorisation holders&#8221; &#8211; Consolidated version, December 2019.<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/COMUNICATE%20DE%20PRESA\/INTREBARI%20SI%20RASPUNSURI_nitrozamine_consolidat_dec2019.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-18-10-2019\/\">Press release<\/a><div class=\"content\"><p><strong>18.10.2019<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nQuestion and Answer Document for marketing authorisation holders in the process of evaluating the potential presence of nitrosamine impurities in manufactured medicinal products for human use and analysing medicinal products at risk<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/COMUNICATE%20DE%20PRESA\/Update_nitrozamine_18%20oct2019.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-30-09-2019\/\">Press release<\/a><div class=\"content\"><p><strong>30.09.2019<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nQUESTIONS AND ANSWERS regarding the document &#8220;Information on nitrosamines, to the attention of marketing authorisation holders&#8221;<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/COMUNICATE%20DE%20PRESA\/Comunicat%20EMA%20Nitrozamine_Qand%20A_ro.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-27-09-2019\/\">Press release<\/a><div class=\"content\"><p><strong>27.09.2019<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release \u2013 INFORMATION ON NITROSAMINES to the attention of marketing authorisation holders<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/COMUNICATE%20DE%20PRESA\/comunicat%20EMA_%20INFORMA%C8%9AII%20despre%20NITROZAMINE%20pt%20DAPP_SEPT2019.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-17-09-2019\/\">Press release<\/a><div class=\"content\"><p><strong>17.09.2019<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on initiating the re-evaluation of ranitidine-containing medicinal products following the detection of the impurity N-nitrosodimethylamine (NDMA) impurity<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/COMUNICATE%20DE%20PRESA\/Comunicat%20EMA%20_ranitidina%20NDMA_ro.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-26-09-2019\/\">Press release<\/a><div class=\"content\"><p><strong>26.09.2019<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on EMA recommendation to companies about taking measures to avoid the occurrence of nitrosamine impurities in medicinal products for human use<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/COMUNICATE%20DE%20PRESA\/Comunicat%20EMA%20catre%20companii%20ref%20impuritati%20nitroz_sept2019.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-13-09-2019\/\">Press release<\/a><div class=\"content\"><p><strong>13.09.2019<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on EMA&#8217;s decision to provide guidance on avoiding the presence of nitrosamine impurities in medicinal products for human use<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/COMUNICATE%20DE%20PRESA\/COMUNICAT%20EMA%20ref%20decizia%20EMA%20de%20a%20oferi%20%C3%AEndrum%C4%83ri%20pt%20evitarea%20prezentei%20nitrozaminelor%20in%20medicamente.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-03-05-2019\/\">Press release<\/a><div class=\"content\"><p><strong>03.05.2019<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on updating information on nitrosamine impurities and continuing EMA actions to prevent the appearance of impurities in medicinal products<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/COMUNICATE%20DE%20PRESA\/actualizare_nitrozamine_ro_apr_2019.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-03-02-2019\/\">Press release<\/a><div class=\"content\"><p><strong>03.02.2019<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on the request addressed to pharmaceutical companies that manufacture medicinal products containing sartans, to review manufacturing processes in order to avoid the presence of nitrosamine impurities<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/COMUNICATE%20DE%20PRESA\/sartani_1%20feb2019.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-10-07-2018\/\">Press release<\/a><div class=\"content\"><p><strong>10.07.2018<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nThe National Agency for Medicines and Medical Devices has requested precautionary recall from the Romanian market of all medicinal products containing valsartan manufactured by the Zhejiang Huahai Pharmaceuticals manufacturers in China, pursuant to recent identification of impurities introduced by the active substance manufacturing process.<br \/>\n<a href=\"\/en\/_\/COMUNICATE DE PRESA\/Comunicat de presa ANMDM valsartan 10.07.2018_en.pdf\" target=\"_blank\" rel=\"noopener\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-13-03-2018\/\">Press release<\/a><div class=\"content\"><p><strong>13.03.2018<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: Prostate cancer medicine Xofigo must not be used with Zytiga and prednisone\/prednisolone.<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2018\/03\/WC500245412.pdf\" target=\"_blank\" rel=\"noopener\">http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2018\/03\/WC500245412.pdf<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-09-03-2018\/\">Press release<\/a><div class=\"content\"><p><strong>09.03.2018<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nPress release: EMA recommends immediate suspension and recall of multiple sclerosis medicine Zinbryta.<br \/>\nNAMMD mention: Zinbryta (daclizumab) is not marketed in Romania on publication of this press release.<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2018\/03\/news_detail_002920.jsp&amp;mid=WC0b01ac058004d5c1\" target=\"_blank\" rel=\"noopener\">http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2018\/03\/news_detail_002920.jsp&amp;mid=WC0b01ac058004d5c1<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-07-03-2018\/\">Press release<\/a><div class=\"content\"><p><strong>07.03.2018<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nGiven the current immunoglobulin crisis on the Romanian market and publication in the press of erroneous information about the application submitted by supplier Torus Pharma, in view of release of a special needs authorisation for human immunoglobulin, the NAMMD hereby states the following:<br \/>\nThe initial application, submitted on 28.12.2017, was not compliant with the provisions of Order of the Minister of Health no. 85\/2013 on approval of the Norms for implementation of provisions of Article 699 (1) and (2) of Law No. 95\/2006 on healthcare reform concerning medicinal products for special needs, referring to, among others, the lack of medical justification issued by special commissions\/directorates of the Ministry of Health, thus prompting the NAMMD to require supplementations in January 2018.<br \/>\nIn the beginning of February 2018, supplier Torus Pharma sent supplementations to the authorisation dossier, on behalf of two Ministry of Health advisory commissions, which have highlighted the fact that the product, manufactured in India, has a composition \u201eslightly inferior as opposed to that of similar products previously available on the pharmaceutical market, due to a smaller IgG and a bigger IgA content\u201d.<br \/>\nMoreover, the NAMMD states that this category of medicinal products \u2013 blood or plasma-derived medicinal products \u2013 involves particular risks in terms of viral safety. Since the respective product is authorised in a non-EU country, rigorous manufacturing and control according to European standards cannot be ensured, as regards: the system of donor selection, authorisation of collecting centres, testing of individual donations, the standard of sensitivity of employed methods, their validation, the traceability system of donations until finished product, also involving maintenance of donation data for a 30-year period, viral safety trials conducted during the manufacturing process, with assessment of the ability of viral elimination\/inactivation, etc. All these issues, detailed in the context of EMA guidelines which should be observed by blood-derived product manufacturers, are corroborated with the existence of a non-EU GMP certificate.<br \/>\nConsidering the aforementioned issues, the NAMMD considers that the non-EU origin of the product cannot guarantee the safety and quality criteria imposed for EU products, and the authorisation for special needs does not allow, in this case (see Order of the Minister of Health no. 85\/2013), neither sufficient assessment in terms of safety and quality of the plasma used in the manufacturing process, nor that of the product\u2019s manufacturing process. Moreover, the NAMMD states that, in this case, a punctual testing of the finished product could not cover all previously mentioned aspects and could not fully guarantee the product\u2019s quality.<br \/>\nThe NAMMD wishes to assure its patients and the public that it strictly adheres to its mission to promote and protect public health by ensuring marketing of medicinal products compliant with top quality, safety and efficacy standards.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-16-02-2018\/\">Press release<\/a><div class=\"content\"><p><strong>16.02.2018<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nThe National Agency for Medicines and Medical Devices (NAMMD) had the honour to host the first workday of the 4th edition of the Patients\u2019 School Masterclass, organised by the Health Policies Magazine and by the the Coalition of Organisations of patients with chronic diseases (COPAC).<br \/>\nThe following participants have replied to questions and manifested total openness toward efficient and constructive communication with patient associations:<br \/>\nConf. Univ. Dr. Diana Paun \u2013 State Counsellor, Presidential Administration<br \/>\nSorina Pintea \u2013 Minister of Health<br \/>\nDr. Octavian Alexandrescu \u2013 Secretary of State \u2013 Ministry of Health<br \/>\nDr. Alexandru Velicu \u2013 NAMMD President<br \/>\nRazvan Vulcanescu \u2013 NHIH President<br \/>\nConf. Univ. Dr. Florin Buicu \u2013 President of the Health and Family Commission, Chamber of Deputies<br \/>\nEmanuel-Gabriel Botnariu \u2013 member of the Commission for Public Health, Senate<br \/>\nRomana Furtuna \u2013 Counsellor of the Minister of Health on the relationship with patient associations and NGOs.<br \/>\nThe NAMMD President has enforced the idea expressed by Sorina Pintea, the Minister of Health, stating the fact that the Agency is ruled by a young team, which has already identified most of the issues for which it is entitled to find solutions.<br \/>\nOnce again, Dr. Velicu highlighted the fact that the role of the NAMMD, as highlighted by Conf. Univ. Dr. Diana Paun as well, is well defined and assumed by all Agency specialists.<br \/>\nThe NAMMD is currently facing a real issue, mentioned by Conf. Univ. Dr. Buicu, a well-known situation which should be discussed publicly (reduced staff, implementation of the Unitary Pay Law, as well as the wish to avoid medicinal product recall or discontinuation in supply of the pharmaceutical market).<br \/>\nAs regards the cooperation with the NHIH, the President said he had met President Razvan Vulcanescu several times, which has led to setup of a working group aiming to identify possibilities for reduction of bureaucracy between the two institutions, which he had noticed back in the days when he was the NAMMD Vice-President.<br \/>\nTo conclude, Dr. Velicu reaffirmed his openness toward proactive communication with patient associations with whom, as he has already discussed with Radu Ganescu, the COPAC President, is about to sign a collaboration protocol, in view of establishing a partnership for identification of the association\u2019s specific issues and of practical solutions for their resolution, and in order to promote an ethical, correct and transparent environment for communication.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-13-02-2018-4\/\">Press release<\/a><div class=\"content\"><p><strong>13.02.2018<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: PRAC recommends that the marketing authorisation of the painkiller flupirtine be withdrawn.<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Flupirtine-containing_medicines\/Recommendation_provided_by_Pharmacovigilance_Risk_Assessment_Committee\/WC500243553.pdf\" target=\"blank\">download document &#8230;<\/a> <\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-13-02-2018-5\/\">Press release<\/a><div class=\"content\"><p><strong>13.02.2018<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nThe EMA Pharmacovigilance Risk Assessment Committee recommends new measures to avoid valproate exposure in pregnancy.<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2018\/02\/news_detail_002901.jsp&#038;mid=WC0b01ac058004d5c1\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-13-02-2018-3\/\">Press release<\/a><div class=\"content\"><p><strong>13.02.2018<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nPRAC recommends updating measures for pregnancy prevention during retinoid use.<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Retinoids_31\/Recommendation_provided_by_Pharmacovigilance_Risk_Assessment_Committee\/WC500243544.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-13-02-2018-2\/\">Press release<\/a><div class=\"content\"><p><strong>13.02.2018<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing.<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Esmya_20\/Under_evaluation\/WC500243545.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-13-02-2018\/\">Press release<\/a><div class=\"content\"><p><strong>13.02.2018<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nThe NAMMD has the pleasure to notify all its stakeholders on receipt of the final assessment reports of the Agency\u2019s audit in the context of the HMA\/EMA Joint Audit Program. The audit was conducted during 17-21 October 2016, together with the audit scheduled by the competent authority of Canada, as a state with which the EU has signed a Mutual Recognition Agreement (MRA), in view of assessment of the legislation implemented in Romania and of the GMP inspection system observed by the NAMMD, as a national competent authority in the field of the medicinal product for human use. Two auditors on behalf of the FDA (the US competent authority) have participated in this audit, as observers, and have surveyed the specific objectives established for the pharmaceutical sector, within the Transatlantic Trade and Investment Partnership.<br \/>\nThe final assessment reports received from Health Canada (the Canadian authority) confirms the conclusion of an equivalence between the GMP-related national legislation and the GMP-related Canadian legislation, as well as between the inspection systems in this field. This is a result of the NAMMD activity and, by reciprocal recognition of GMP inspections, represents not only the reaffirmation of the efforts of NAMMD specialists, but also an access of Romanian medicinal product manufacturers to the Canadian market.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-09-02-2018\/\">Press release<\/a><div class=\"content\"><p><strong>09.02.2018<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nA working meeting has taken place today at the site of the National Agency for Medicines and Medical Devices (NAMMD), with the participation of Sorina Pintea, Octavian Alexandrescu, Secretary of State within the Ministry of Health, Dr. Alexandru Velicu, NAMMD President, representatives of wholesale distributors of immunoglobulins and CN Unifarm SA, representatives of the NAMMD.<br \/>\nThe Meeting\u2019s theme was the crisis generated by the discontinuity in supply of the pharmaceutical market with immunoglobulins, medicinal products addressing the primary immunodeficiency disease, considering that manufacturers have benefitted from exemption from the clawback tax for two years.<br \/>\nThe Minister of Health, Mrs. Sorina Pintea, has demanded accurate information about these medicinal products, as regards the possibility of ensuring the supply of immunoglobulins, in the coming period and hereinafter, in 2018.<br \/>\nConsidering the extension of this crisis situation, MH representatives have announced the scheduling in February of a meeting with immunoglobulin manufacturers, who represent the first link in the supply chain of patients with such products.<br \/>\nAccording to the discussions, a certain amount of three types of immunoglobulins (IG Vena, Intratect and Gammanorm) is about to be marketed during the 1st quarter of 2018, with the possibility of ongoing supplementation.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-30-01-2018\/\">Press release<\/a><div class=\"content\"><p><strong>30.01.2018<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nHydroxyethyl-starch solutions for infusion to be suspended \u2013 CMDh endorses PRAC recommendation.<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2018\/01\/WC500242423.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-18-01-2018-2\/\">Press release<\/a><div class=\"content\"><p><strong>18.01.2018<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nPRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market.<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Hydroxyethyl_starch_107i\/Recommendation_provided_by_Pharmacovigilance_Risk_Assessment_Committee\/WC500241325.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-18-01-2018\/\">Press release<\/a><div class=\"content\"><p><strong>18.01.2018<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nThe National Agency for Medicines and Medical Devices (NAMMD) joined the Ministry of Health in expressing, via a letter addressed to the Medical Directorate of the National Defence Ministry, its satisfaction concerning the perspective of relaunching of the Cantacuzino Institute and of recommencing vaccine manufacturing in Romania, given the official subordination of the institute to the National Defence Ministry.<br \/>\nNAMMD specialists reiterate their full willingness and openness to communication and sharing of expertise for implementation of EU regulations in the field of the medicinal product for human use. Thus, supporting the relaunching of such a strategically important institute represents is, for the Agency, both an honour and a duty to support the Romanian institute in order to once again become a European centre for vaccine manufacturing.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-16-01-2018\/\">Press release<\/a><div class=\"content\"><p><strong>16.01.2018<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nAs a reply to the recent press article (<a href=\"https:\/\/www.hotnews.ro\/stiri-esential-22223144-vlad-mixich-fost-vicepresedinte-agentiei-nationale-medicamentului-anm-sunt-42-paznici-operatori-dar-doar-4-oameni-decid-daca-medicament-merita-sau-nu-fie-compensat.htm\" target=\"_blank\" rel=\"noopener\">https:\/\/www.hotnews.ro\/stiri-esential-22223144-vlad-mixich-fost-vicepresedinte-agentiei-nationale-medicamentului-anm-sunt-42-paznici-operatori-dar-doar-4-oameni-decid-daca-medicament-merita-sau-nu-fie-compensat.htm<\/a>), the NAMMD wishes to inform its collaborators, partners, patients, public and all interested persons that it has the priority, for the upcoming period, of making amendments related to the organisation, operation, wage levels of employees and other issues, so as to ensure optimisation of the Agency\u2019s activity.<br \/>\nBoth specialists involved in assessment and authorisation of medicinal products for human use, in pharmaceutical inspection, pharmacovigilance, medical technologies assessment, authorisation of clinical trials conducted in Romania, in all issues related to medical devices, or in proposition of profile regulations, as well as the supporting staff of the Agency, perform and develop their professional expertise under specific conditions, unique at national level. The appropriate amendment of the regulatory framework of the NAMMD organisation and operation is entitled to allow implementation of certain working conditions, comparable to those of other competent authorities in the field, without which the Agency\u2019s mission within the EU network of specific national authorities cannot be optimally fulfilled.<br \/>\nGiven its good relationship with the Ministry of Health, the NAMMD expresses its belief according to which its ongoing approaches shall have a happy end, thus leading to a good performance of the NAMMD activity, whose main purpose is the safeguard of public health.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-12-01-2018\/\">Press release<\/a><div class=\"content\"><p><strong>12.01.2018<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nIn the context of recent press articles, the National Agency for Medicines and Medical Devices (NAMMD) reminds the importance of appropriate use of ibuprofen-containing medicinal products.<br \/>\n<a href=\"\/en\/_\/COMUNICATE DE PRESA\/ANMDM_ibuprofen.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-20-12-2017\/\">Press release<\/a><div class=\"content\"><p><strong>20.12.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nModified-release paracetamol-containing products to be suspended from EU market.<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2017\/12\/WC500240441.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-20-12-2017-2\/\">Press release<\/a><div class=\"content\"><p><strong>20.12.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on updated recommendations for contraception in men and women taking mycophenolate medicines.<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2017\/12\/news_detail_002871.jsp&#038;mid=WC0b01ac058004d5c1\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-11-12-2017-3\/\">Press release<\/a><div class=\"content\"><p><strong>11.12.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nPRAC confirms that modified-release paracetamol should be suspended from market.<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Paracetamol_31\/Recommendation_provided_by_Pharmacovigilance_Risk_Assessment_Committee\/WC500239709.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-11-12-2017-2\/\">Press release<\/a><div class=\"content\"><p><strong>11.12.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA starts review of Esmya for uterine fibroids.<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Esmya_20\/Procedure_started\/WC500239713.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-11-12-2017\/\">Press release<\/a><div class=\"content\"><p><strong>11.12.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nWarning about use of prostate cancer medicine Xofigo in combination with Zytiga and prednisone or prednisolone.<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Xofigo_20\/Procedure_started\/WC500239721.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-20-11-2017\/\">Press release<\/a><div class=\"content\"><p><strong>20.11.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\n<strong>Contribute to better medicinal product safety by reporting suspected adverse drug reactions!<\/strong><br \/>\nThe National Agency for Medicines and Medical Devices (NAMMD) is launching the second social media campaign for the general public.<br \/>\n<a href=\"\/en\/_\/COMUNICATE DE PRESA\/Contribute to better medicinal product safety by reporting suspected adverse drug reactions.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-15-11-2017\/\">Press release<\/a><div class=\"content\"><p><strong>15.11.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA concludes review of Zinbryta and confirms further restrictions to reduce risk of liver damage.<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2017\/11\/WC500238075.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-03-11-2017\/\">Press release<\/a><div class=\"content\"><p><strong>03.11.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nReview of flupirtine-containing medicines started.<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2017\/10\/news_detail_002838.jsp&#038;mid=WC0b01ac058004d5c1\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-01-11-2017-2\/\">Press release<\/a><div class=\"content\"><p><strong>01.11.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA starts new review of hydroxyethyl-starch containing medicines.<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2017\/10\/news_detail_002836.jsp&#038;mid=WC0b01ac058004d5c1\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-01-11-2017\/\">Press release<\/a><div class=\"content\"><p><strong>01.11.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nPRAC recommends further restrictions for multiple sclerosis medicine Zinbryta due to risk of serious liver damage.<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2017\/10\/WC500237824.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-30-10-2017\/\">Press release<\/a><div class=\"content\"><p><strong>30.10.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nNAMMD position in response to recent press allegations<br \/>\nThe National Agency for Medicines and Medical Devices (NAMMD) is surprised to find from the media that it allegedly had refused donations in the aftermath of the Collective Club related tragedy: &#8220;To address the NMA and the ministry and to be sent home and be advised not to make a stir with one\u2019s donations\u2026. And it was not just our company to be turned down&#8230;&#8221;<br \/>\nFor proper information of the general public, of patients and media representatives who give due regard to their own calling by upholding the truth, the NAMMD would like to hereby make the following clarifications on:<br \/>\n&#8211; the legal basis of donations: Order of the Minister of Health no. 1032\/2011 for approval of Rules on donations of medicinal products, sanitation supplies, medical devices, vaccines, sera and related supplies<br \/>\n&#8211; issue on 6 November 2015 of Order of the Minister of Health no. 1409\/2015 for waiver from provisions of Article 10 of the Rules on donations of medicinal products, sanitation supplies, medical devices, vaccines, sera and related supplies, approved through Order of the Minister of Health no. 1032\/2011, regarding healthcare facilities with beds delivering medical services to in-patient casualties of the Collective Club and the Vel Pitar Brasov factory incidents.<br \/>\nAccordingly, donations have been accepted of medication containing psychotropic and narcotic drugs, necessary for fire in-patients.<br \/>\n&#8211; emergency grant by the NAMMD from 4 November to 12 December 2015 of 10 approvals for donation, all concerning medications intended for major burn patients, hospitalised in various Bucharest hospitals;<br \/>\n&#8211; emergency grant by the NAMMD, on request by the Ministry of Health Advisory Commission for Plastic Surgery, Aesthetic and Reconstructive Microsurgery of Authorisations for special needs medicines for two products.<br \/>\nThe NAMMD hereby points out its deep regret at the defamation of its work, ultimately so often unjustifiably engendering patients and the general public\u2019s confusion and mistrust!! In this regard, the NAMMD would like to require the former Minister of Health, Mr. Vlad Voiculescu, to provide actual data on the company\/companies whose messages he relays in his Facebook page, thus enabling the Agency to perform all verifications necessary.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-10-10-2017\/\">Press release<\/a><div class=\"content\"><p><strong>10.10.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nCountdown to launch of new EudraVigilance System: final preparations for change-over to new system underway for go live date on 22 November 2017<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2017\/10\/news_detail_002820.jsp&#038;mid=WC0b01ac058004d5c1\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-06-10-2017\/\">Press release<\/a><div class=\"content\"><p><strong>06.10.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: PRAC recommends modified-release paracetamol be removed from market (update: 29 September 2017)<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Paracetamol_31\/Recommendation_provided_by_Pharmacovigilance_Risk_Assessment_Committee\/WC500234111.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-25-09-2017\/\">Press release<\/a><div class=\"content\"><p><strong>25.09.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA concludes review of human factor VIII medicines authorised in EU<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2017\/09\/WC500234822.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-11-09-2017\/\">Press release<\/a><div class=\"content\"><p><strong>11.09.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: PRAC recommends modified-release paracetamol be removed from market<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Paracetamol_31\/Recommendation_provided_by_Pharmacovigilance_Risk_Assessment_Committee\/WC500234111.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-07-09-2017\/\">Press release<\/a><div class=\"content\"><p><strong>07.09.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nPRAC confirms its previous conclusion on risk of inhibitor development with factor VIII medicines<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Factor_VIII_31\/Recommendation_provided_by_Pharmacovigilance_Risk_Assessment_Committee\/WC500234110.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-16-08-2017\/\">Press release<\/a><div class=\"content\"><p><strong>16.08.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA seeks views of public during its safety review of valproate Registration opens for first public hearing<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2017\/07\/WC500231106.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-04-08-2017\/\">Press release<\/a><div class=\"content\"><p><strong>04.08.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nCMDh confirms that methylprednisolone injections containing lactose must not be given to patients allergic to cow&#8217;s milk proteins<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2017\/07\/WC500232679.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-31-07-2017\/\">Press release<\/a><div class=\"content\"><p><strong>31.07.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA&#8217;s final opinion confirms restrictions on use of linear gadolinium agents in body scans &#8211; Recommendations conclude EMA&#8217;s scientific review of gadolinium deposition in brain and other tissues<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/gadolinium_contrast_agents_31\/Opinion_provided_by_Committee_for_Medicinal_Products_for_Human_Use\/WC500231824.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-11-07-2017-2\/\">Press release<\/a><div class=\"content\"><p><strong>11.07.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA restricts use of multiple sclerosis medicine Zinbryta<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2017\/07\/WC500230922.pdf \" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-11-07-2017\/\">Press release<\/a><div class=\"content\"><p><strong>11.07.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nPRAC recommends that injectable methylprednisolone products containing lactose must not be given to patients allergic to cow&#8217;s milk proteins<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Lactose_of_bovine_origin_31\/Recommendation_provided_by_Pharmacovigilance_Risk_Assessment_Committee\/WC500230921.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-10-07-2017\/\">Press release<\/a><div class=\"content\"><p><strong>10.07.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nPRAC confirms restrictions on the use of linear gadolinium agents<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/gadolinium_contrast_agents_31\/Recommendation_provided_by_Pharmacovigilance_Risk_Assessment_Committee\/WC500230928.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-29-06-2017\/\">Press release<\/a><div class=\"content\"><p><strong>29.06.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA recommends that Symbioflor 2 can continue to be used for irritable bowel syndrome<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2017\/06\/WC500229911.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-14-06-2017\/\">Press release<\/a><div class=\"content\"><p><strong>14.06.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nPRAC concludes there is no evidence of a change in known risk of neutropenic enterocolitis with docetaxel<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2017\/06\/WC500229321.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-13-06-2017\/\">Press release<\/a><div class=\"content\"><p><strong>13.06.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA reviews multiple sclerosis medicine Zinbryta<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Zinbryta_20\/Procedure_started\/WC500229330.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-12-06-2017\/\">Press release<\/a><div class=\"content\"><p><strong>12.06.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nPRAC concludes there is no clear and consistent evidence of a difference in inhibitor development between classes of factor VIII medicines<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Factor_VIII_31\/Recommendation_provided_by_Pharmacovigilance_Risk_Assessment_Committee\/WC500226901.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-23-05-2017-2\/\">Press release<\/a><div class=\"content\"><p><strong>25.05.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nAnnouncement of the EMA Management Board &#8211; Confirmation of full functionality of the EudraVigilance database<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2017\/05\/news_detail_002752.jsp&#038;mid=WC0b01ac058004d5c1\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-23-05-2017\/\">Press release<\/a><div class=\"content\"><p><strong>23.05.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA recommends changes to prescribing information for vancomycin antibiotics<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Vancomycin_31\/WC500228064.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-12-05-2017-2\/\">Press release<\/a><div class=\"content\"><p><strong>12.05.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nThe NAMMD hereby informs on publication of the EMA annual report for 2016<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Annual_report\/2017\/05\/WC500227334.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-12-05-2017\/\">Press release<\/a><div class=\"content\"><p><strong>12.05.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nThe National Agency for Medicines and Medical Devices would like to invite all stakeholders to take part in the survey launched by the European Medicines Agency.<br \/>\n<a href=\"\/en\/_\/COMUNICATE DE PRESA\/The NAMMD would  like to invite all stakeholders to take part in the survey launched by the EMA.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-09-05-2017\/\">Press release<\/a><div class=\"content\"><p><strong>09.05.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: PRAC concludes there is no clear and consistent evidence of a difference in inhibitor development between classes of factor VIII medicines<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Factor_VIII_31\/Recommendation_provided_by_Pharmacovigilance_Risk_Assessment_Committee\/WC500226901.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-12-04-2017-2\/\">Press release<\/a><div class=\"content\"><p><strong>12.04.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA concludes safety review of Uptravi<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2017\/04\/WC500225352.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-12-04-2017\/\">Press release<\/a><div class=\"content\"><p><strong>12.04.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nPRAC concludes assessment of gadolinium agents used in body scans and recommends regulatory actions, including suspension for some marketing authorisations \u2013 Update of 7 Aprilie 2017<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/gadolinium_contrast_agents_31\/Recommendation_provided_by_Pharmacovigilance_Risk_Assessment_Committee\/WC500223161.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-27-03-2017\/\">Press release<\/a><div class=\"content\"><p><strong>27.03.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2017\/03\/WC500224392.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-14-03-2017-3\/\">Press release<\/a><div class=\"content\"><p><strong>14.03.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: PRAC concludes assessment of gadolinium agents used in body scans and recommends regulatory actions, including suspension for some marketing authorisations<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2017\/03\/WC500223209.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-14-03-2017-2\/\">Press release<\/a><div class=\"content\"><p><strong>14.03.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on new review of valproate use in pregnancy and women of childbearing age<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Valproate_2017_31\/Procedure_started\/WC500223242.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-14-03-2017\/\">Press release<\/a><div class=\"content\"><p><strong>14.03.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA reviewing cancer medicine docetaxel<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2017\/03\/WC500223211.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-06-03-2017\/\">Press release<\/a><div class=\"content\"><p><strong>06.03.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nThe National Agency for Medicines and Medical Devices (NAMMD), member of the European network of National Competent Authorities (NCAs) coordinated by the European Medicines Agency (EMA) expresses its satisfaction due to the agreement signed between regulatory authorities in the EU and the US, concerning mutual recognition of inspections conducted at medicinal product manufacturing sites.<br \/>\nThe agreement will enable both the EU authorities and the FDA to make better use of their inspection resources to help them to focus on other parts of the world where active pharmaceutical ingredients and medicinal products for the EU or US markets are manufactured. This will ensure that patients can rely on the quality, safety and efficacy of all medicinal products, no matter where they have been produced.<br \/>\nThe agreement is underpinned by robust evidence that the EU and the US have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines. In this context, it is worth mentioning that the NAMMD complies with the procedural framework imposed by EU legislation for pharmaceutical inspections.<br \/>\nTeams from the European Commission, NCA, EMA and FDA have been audited and assessing the respective supervisory systems since May 2014, and have worked closely together to reach this agreement.<br \/>\nThe Agreement is an Annex to the EU-US Mutual Recognition Agreement which was signed in 1998, but is not yet implemented. Many provisions of the agreement have already entered into force and others will enter into force on 1 November 2017. The text of the Agreement is now published on the website of the European Commission\u2019s Directorate General for Trade.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-27-02-2017\/\">Press release<\/a><div class=\"content\"><p><strong>27.02.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEma press release on SGLT2 inhibitors: information on potential risk of toe amputation to be included in prescribing information<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2017\/02\/WC500222191.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-14-02-2017-3\/\">Press release<\/a><div class=\"content\"><p><strong>14.02.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA to review persistence of side effects known to occur with quinolone and fluoroquinolone antibiotics<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Quinolone_fluoroquinolone_31\/Procedure_started\/WC500221432.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-14-02-2017-2\/\">Press release<\/a><div class=\"content\"><p><strong>14.02.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA reviewing safety of Uptravi for pulmonary arterial hypertension<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2017\/02\/WC500221423.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-14-02-2017\/\">Press release<\/a><div class=\"content\"><p><strong>14.02.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: PRAC concludes that diabetes medicine canagliflozin may contribute to risk of toe amputation<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/SGLT2_inhibitors_Canagliflozin_20\/Recommendation_provided_by_Pharmacovigilance_Risk_Assessment_Committee\/WC500221431.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-01-02-2017\/\">Press release<\/a><div class=\"content\"><p><strong>01.02.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: Dienogest\/ethinylestradiol can be used for acne after certain other treatments have failed<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2017\/01\/news_detail_002685.jsp&#038;mid=WC0b01ac058004d5c1\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-18-01-2017\/\">Press release<\/a><div class=\"content\"><p><strong>18.01.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nConsidering the obligation, in accordance with legislation in force, of declaring sponsoring by manufacturers, MAHs or their representatives in Romania, wholesale and retail distributors of medicinal products in Romania, as well as by respective recipients, before 31 March 2017, the NAMMD recommends the use of electronic declaration forms and the Guidelines on completion of declaration forms, online for recipients and by e-mail for sponsors, available on the NAMMD website, at <a href=\"http:\/\/www.anm.ro\/en\/medicamente-de-uz-uman\/publicitate\/sponsorizari-medicamente-de-uz-uman\/\">http:\/\/www.anm.ro\/en\/medicamente-de-uz-uman\/publicitate\/sponsorizari-medicamente-de-uz-uman\/<\/a>.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-21-12-2016-2\/\">Press release<\/a><div class=\"content\"><p><strong>21.12.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2016\/12\/WC500218204.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-21-12-2016\/\">Press release<\/a><div class=\"content\"><p><strong>21.12.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on start of a review concerning the conduct of studies at Micro Therapeutic Research Labs, India<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Micro_Therapeutic_Research_31\/WC500218191.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-08-12-2016-2\/\">Press release<\/a><div class=\"content\"><p><strong>08.12.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nThe National Agency for Medicines and Medical Devices (NAMMD) would like to announce the launch of the online Form for reporting suspected adverse reactions to medicinal products, the fastest and most up-to-date manner of reporting. The online form has been elaborated with support from colleagues from the fellow medicinal product competent authority of the United Kingdom , in the context of the Joint action project \u201eStrengthening Collaboration for Operating Pharmacovigilance in Europe \u2013SCOPE Joint Action\u201d, financed by the European Union Health Programme.<br \/>\nReporting of suspected adverse reaction to medicinal products is important; it is the only way you can contribute to better medicinal product safety. <\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-08-12-2016\/\">Press release<\/a><div class=\"content\"><p><strong>08.12.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: PRAC warns of risk of hepatitis B re-activation with direct-acting antivirals for hepatitis C<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2016\/12\/WC500217496.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-20-10-2016\/\">Press release<\/a><div class=\"content\"><p><strong>20.10.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nPress release: EMA recommends measures to ensure safe use of Keppra oral solution<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/contacts\/not_yet_available.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-19-10-2016\/\">Press release<\/a><div class=\"content\"><p><strong>19.10.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: Use of metformin to treat diabetes now expanded to patients with moderately reduced kidney function<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2016\/10\/WC500214248.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-21-09-2016\/\">Press release<\/a><div class=\"content\"><p><strong>21.09.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: Pharmaceutics International Inc., US: supply of noncritical medicines to EU to be stopped due to manufacturing failings<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Pharmaceutics_International_31\/WC500212902.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-09-08-2016-2\/\">Press release<\/a><div class=\"content\"><p><strong>09.08.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: Adaptive pathways: key learnings and next steps EMA publishes report on pilot project and will organise workshop in December to further explore concept<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2016\/08\/WC500211522.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-09-08-2016\/\">Press release<\/a><div class=\"content\"><p><strong>09.08.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: EU collaboration strengthens safety monitoring of medicines<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2016\/08\/news_detail_002588.jsp&#038;mid=WC0b01ac058004d5c1\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-26-07-2016-2\/\">Press release<\/a><div class=\"content\"><p><strong>26.07.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: CHMP confirms recommendations for use of Zydelig<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2016\/07\/WC500210868.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-26-07-2016\/\">Press release<\/a><div class=\"content\"><p><strong>26.07.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA recommends suspension of medicines over flawed studies at Semler Research Centre<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2016\/07\/WC500210870.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-17-07-2016\/\">Press release<\/a><div class=\"content\"><p><strong>17.07.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: Proposals to revise guidance on first-in-human clinical trials<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2016\/07\/WC500210845.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-11-07-2016-4\/\">Press release<\/a><div class=\"content\"><p><strong>11.07.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: Review of factor VIII medicines and risk of developing inhibitors in patients starting treatment for haemophilia A<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Factor_VIII_31\/Procedure_started\/WC500209984.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-11-07-2016-3\/\">Press release<\/a><div class=\"content\"><p><strong>11.07.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: EMA starts review of retinoid medicines<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Retinoids_31\/Procedure_started\/WC500209971.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-11-07-2016-2\/\">Press release<\/a><div class=\"content\"><p><strong>11.07.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: EMA to review modified-release paracetamol<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Paracetamol_31\/Procedure_started\/WC500209980.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-11-07-2016\/\">Press release<\/a><div class=\"content\"><p><strong>11.07.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: PRAC concludes review of Zydelig and issues updated recommendations for use<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2016\/07\/WC500209936.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-29-06-2016-4\/\">Press release<\/a><div class=\"content\"><p><strong>29.06.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on start of review of medicines manufactured at Pharmaceutics International Inc., USA<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2016\/06\/WC500209328.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-29-06-2016-3\/\">Press release<\/a><div class=\"content\"><p><strong>29.06.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2016\/06\/WC500209303.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-29-06-2016-2\/\">Press release<\/a><div class=\"content\"><p><strong>29.06.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA warns that Noxafil tablets and oral suspension have different doses and are not interchangeable<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2016\/06\/WC500209313.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-29-06-2016\/\">Press release<\/a><div class=\"content\"><p><strong>29.06.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: Adempas not for use in patients with pulmonary hypertension caused by idiopathic interstitial pneumonia<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2016\/06\/WC500209316.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-15-06-2016\/\">Press release<\/a><div class=\"content\"><p><strong>15.06.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: Single, central platform now mandatory for all periodic safety update reports<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2016\/06\/news_detail_002547.jsp&#038;mid=WC0b01ac058004d5c1\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-30-05-2016\/\">Press release<\/a><div class=\"content\"><p><strong>30.05.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: Improving safety of first-in-human clinical trials<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2016\/05\/WC500207280.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-18-05-2016\/\">Press release<\/a><div class=\"content\"><p><strong>18.05.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on inhibitor development in previously untreated patients with severe haemophilia A treated with recombinant factor VIII products<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Report\/2016\/05\/WC500206411.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-05-05-2016-2\/\">Press release<\/a><div class=\"content\"><p><strong>05.05.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on start of a review on the conduct of studies at Semler Research Centre Private Ltd, Bangalore, India<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2016\/04\/WC500205577.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-05-05-2016\/\">Press release<\/a><div class=\"content\"><p><strong>05.05.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on completion of review of inhaled corticosteroids for chronic obstructive pulmonary disease<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2016\/04\/WC500205577.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-20-04-2016-2\/\">Press release<\/a><div class=\"content\"><p><strong>20.04.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: Listening to the public\u2019s views on the safety of medicines<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2016\/04\/WC500204898.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-20-04-2016\/\">Press release<\/a><div class=\"content\"><p><strong>20.04.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nPress release: EMA reviews direct-acting antivirals for hepatitis C<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Direct-acting_antivirals_for_hepatitis_C_20\/Procedure_started\/WC500204893.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-19-04-2016\/\">Press release<\/a><div class=\"content\"><p><strong>19.04.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nPress release: EMA reviews diabetes medicine canagliflozin<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/contacts\/not_yet_available.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-04-04-2016-3\/\">Press release<\/a><div class=\"content\"><p><strong>04.04.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on start of a review concerning the conduct of studies at the Alkem Laboratories Ltd site, Taloja, India<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Alkem_31\/WC500204157.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-04-04-2016-2\/\">Press release<\/a><div class=\"content\"><p><strong>04.04.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: Review of Symbioflor 2 started<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Symbioflor_2_31\/WC500204152.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-04-04-2016\/\">Press release<\/a><div class=\"content\"><p><strong>04.04.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: CMDh endorses revocation of authorisations for fusafungine sprays used to treat airway infections<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2016\/03\/news_detail_002500.jsp&#038;mid=WC0b01ac058004d5c1\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-01-04-2016\/\">Press release<\/a><div class=\"content\"><p><strong>01.04.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: Review of vancomycin-containing medicines started<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Vancomycin_31\/WC500204131.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-22-03-2016-2\/\">Press release<\/a><div class=\"content\"><p><strong>22.03.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on review of gadolinium contrast agents used in MRI scans<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/gadolinium_contrast_agents_31\/Procedure_started\/WC500203487.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-22-03-2016\/\">Press release<\/a><div class=\"content\"><p><strong>22.03.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: PRAC reviews known risk of pneumonia with inhaled corticosteroids for chronic obstructive pulmonary disease<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Inhaled_corticosteroids_Article_31\/Recommendation_provided_by_Pharmacovigilance_Risk_Assessment_Committee\/WC500203472.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-21-03-2016-2\/\">Press release<\/a><div class=\"content\"><p><strong>21.03.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on review of direct-acting antivirals for hepatitis C<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Direct-acting_antivirals_for_hepatitis_C_20\/Procedure_started\/WC500203479.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-21-03-2016\/\">Press release<\/a><div class=\"content\"><p><strong>21.03.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on recommendation of new safety measures for Zydelig<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2016\/03\/WC500203474.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-02-03-2016-3\/\">Press release<\/a><div class=\"content\"><p><strong>02.03.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA confirms recommendations to minimise risk of brain infection PML with Tysabri<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2016\/02\/news_detail_002476.jsp&#038;mid=WC0b01ac058004d5c1\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-02-03-2016-2\/\">Press release<\/a><div class=\"content\"><p><strong>02.03.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA confirms recommendations to minimise ketoacidosis risk with SGLT2 inhibitors for diabetes<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2016\/02\/news_detail_002477.jsp&#038;mid=WC0b01ac058004d5c1\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-02-03-2016\/\">Press release<\/a><div class=\"content\"><p><strong>02.03.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on start of review of medicines containing dienogest 2 mg and ethinylestradiol 0.03 mg for acne<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Dienogest_Ethinylestradiol_31\/Opinion_provided_by_Committee_for_Medicinal_Products_for_Human_Use\/WC500202427.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-17-02-2016-2\/\">Press release<\/a><div class=\"content\"><p><strong>17.02.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on SGLT2 inhibitors: PRAC makes recommendations to minimise risk of diabetic ketoacidosis<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2016\/02\/news_detail_002470.jsp&#038;mid=WC0b01ac058004d5c1\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-17-02-2016\/\">Press release<\/a><div class=\"content\"><p><strong>17.02.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on updated recommendations to minimise the risk of the rare brain infection PML with Tysabri<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2016\/02\/news_detail_002471.jsp&#038;mid=WC0b01ac058004d5c1\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-16-02-2016\/\">Press release<\/a><div class=\"content\"><p><strong>16.02.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: PRAC recommends that fusafungine nose and mouth sprays are no longer marketed<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2016\/02\/news_detail_002469.jsp&#038;mid=WC0b01ac058004d5c1\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-09-02-2016-2\/\">Press release<\/a><div class=\"content\"><p><strong>09.02.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nPress release: EMA concludes defective device in ROCKET study does not impact Xarelto\u2019s safety<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2016\/02\/news_detail_002465.jsp&#038;mid=WC0b01ac058001d126\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-09-02-2016\/\">Press release<\/a><div class=\"content\"><p><strong>09.02.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nPress release: EMA sets up task force on Zika virus<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2016\/02\/news_detail_002466.jsp&#038;mid=WC0b01ac058004d5c1\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-02-02-2016\/\">Press release<\/a><div class=\"content\"><p><strong>02.02.2016<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: Review of metformin-containing medicines started<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Metformin_31\/WC500200713.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-29-12-2015\/\">Press release<\/a><div class=\"content\"><p><strong>29.12.2015<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on new recommendations to minimise risks of the rare brain infection PML (Progressive multifocal leukoencephalopathy) and a type of skin cancer with Gilenya (fingolimod)<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2015\/12\/WC500199041.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-24-11-2015\/\">Press release<\/a><div class=\"content\"><p><strong>24.11.2015<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on HPV vaccines: EMA confirms evidence does not support that they cause CRPS or POTS<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2015\/11\/news_detail_002436.jsp&#038;mid=WC0b01ac058004d5c1\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-06-11-2015\/\">Press release<\/a><div class=\"content\"><p><strong>06.11.2015<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: review concludes evidence does not support that HPV vaccines cause CRPS or POTS<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2015\/11\/news_detail_002429.jsp&#038;mid=WC0b01ac058004d5c1\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-28-10-2015-4\/\">Press release<\/a><div class=\"content\"><p><strong>28.10.2015<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on recommendation of additional measures to prevent use of mycophenolate in pregnancy<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2015\/10\/WC500195985.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-28-10-2015-3\/\">Press release<\/a><div class=\"content\"><p><strong>28.10.2015<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: Inductos to be suspended in the EU<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2015\/10\/WC500195992.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-28-10-2015-2\/\">Press release<\/a><div class=\"content\"><p><strong>28.10.2015<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on Updated recommendations to minimise the risk of the rare brain infection PML with Tecfidera<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2015\/10\/WC500196017.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-28-10-2015\/\">Press release<\/a><div class=\"content\"><p><strong>28.10.2015<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on updated advice on body fat changes and lactic acidosis with HIV medicines<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2015\/10\/WC500195982.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-14-09-2015\/\">Press release<\/a><div class=\"content\"><p><strong>14.09.2015<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on start of review of nasal and mouth sprays containing fusafungine<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Fusafungine_31\/Procedure_started\/WC500193294.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-29-07-2015\/\">Press release<\/a><div class=\"content\"><p><strong>29.07.2015<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nPress release: EMA to review Inductos<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2015\/07\/WC500190479.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-14-07-2015\/\">Press release<\/a><div class=\"content\"><p><strong>14.07.2015<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: EMA to further clarify safety profile of human papillomavirus (HPV) vaccines<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2015\/07\/WC500189481.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-07-07-2015\/\">Press release<\/a><div class=\"content\"><p><strong>07.07.2015<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on improving safety of medicines across Europe<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2015\/07\/news_detail_002361.jsp&#038;mid=WC0b01ac058004d5c1\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-30-06-2015\/\">Press release<\/a><div class=\"content\"><p><strong>30.06.2015<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on better training tools recommended to support patients using adrenaline auto-injectors<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2015\/06\/WC500188786.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-16-06-2015\/\">Press release<\/a><div class=\"content\"><p><strong>16.06.2015<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on review of diabetes medicines called SGLT2 inhibitors started<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/SGLT2_inhibitors__20\/Procedure_started\/WC500187926.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-27-05-2015\/\">Press release<\/a><div class=\"content\"><p><strong>27.05.2015<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on updated advice on use of high-dose ibuprofen<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2015\/05\/WC500187108.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-13-05-2015-2\/\">Press release<\/a><div class=\"content\"><p><strong>13.05.2015<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: review of Tysabri started<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Tysabri_20\/Procedure_started\/WC500186685.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-13-05-2015\/\">Press release<\/a><div class=\"content\"><p><strong>13.05.2015<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on start of review of inhaled corticosteroids for chronic obstructive pulmonary disease<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Inhaled_corticosteroids_Article_31\/Procedure_started\/WC500186690.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-28-04-2015-2\/\">Press release<\/a><div class=\"content\"><p><strong>28.04.2015<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: Codeine not to be used in children below 12 years for cough and cold<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2015\/04\/WC500186162.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-28-04-2015\/\">Press release<\/a><div class=\"content\"><p><strong>28.04.2015<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA recommends avoidance of certain hepatitis C medicines and amiodarone together<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2015\/04\/WC500186152.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-16-04-2015\/\">Press release<\/a><div class=\"content\"><p><strong>16.04.2015<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on PRAC recommends updating advice on use of high-dose ibuprofen<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2015\/04\/WC500185426.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-31-03-2015-2\/\">Press release<\/a><div class=\"content\"><p><strong>31.03.2015<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on further measures to minimise risk of osteonecrosis of the jaw with bisphosphonate medicine<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2015\/03\/WC500184865.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-31-03-2015\/\">Press release<\/a><div class=\"content\"><p><strong>31.03.2015<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on new restrictions to minimise the risks of effects on heart rhythm with hydroxyzine-containing medicines<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2015\/03\/WC500184902.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-17-03-2015-2\/\">Press release<\/a><div class=\"content\"><p><strong>17.03.2015<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: PRAC recommends restrictions on the use of codeine for cough and cold in children<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2015\/03\/WC500184258.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-17-03-2015\/\">Press release<\/a><div class=\"content\"><p><strong>17.03.2015<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release: PRAC recommends further measures to minimise risk of osteonecrosis of the jaw with bisphosphonate medicine<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2015\/03\/WC500184259.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-04-03-2015\/\">Press release<\/a><div class=\"content\"><p><strong>04.03.2015<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nThe National Agency for Medicines and Medical Devices (NAMMD) hereby informs on availability of a form for reporting of adverse reactions to medicinal products, including vaccines, by patients, patient relatives or caregivers. The form for reporting adverse reactions available to patients, by means of which patients, their relatives or caregivers can notify adverse reactions following administration of medicinal products, vaccines included. The suspected adverse reaction reporting form is posted on the NAMMD website, together with a number of related clarifications and pieces of information&#8230;<br \/>\n<a href=\"\/en\/_\/Important%20notification%20adverse%20reaction%2004.03.2015.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-02-03-2015\/\">Press release<\/a><div class=\"content\"><p><strong>02.03.2015<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release: Ambroxol and bromhexine expectorants: safety information to be updated<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Ambroxol_and_bromhexine_31\/Position_provided_by_CMDh\/WC500183250.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-24-02-2015\/\">Press release<\/a><div class=\"content\"><p><strong>24.02.2015<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\n<strong>The NAMMD hereby informs<\/strong> on results of tests conducted in NAMMD laboratories on samples of <strong>Imovax dT<\/strong> (marketing authorisation holder: Sanofi Pasteur SA, France), sampled from batches for which potential adverse reactions have been reported after vaccination in children aged 14, in accordance with the approved vaccination schedule in Romania.<br \/>\nNo quality non-compliances have been detected and <strong>laboratory test results are compliant<\/strong> with manufacturer\u2019s product specifications for the finished product and corresponding PhEur monograph from the European Pharmacopoeia.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-18-02-2015\/\">Press release<\/a><div class=\"content\"><p><strong>18.02.2015<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release: PRAC recommends new measures to minimise known heart risks of hydroxyzine-containing medicines<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2015\/02\/WC500182462.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-27-01-2015-3\/\">Press release<\/a><div class=\"content\"><p><strong>27.01.2015<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release on GVK Biosciences: European Medicines Agency recommends suspending medicines over flawed studies<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2015\/01\/WC500180902.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-27-01-2015-2\/\">Press release<\/a><div class=\"content\"><p><strong>27.01.2015<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nQuestions and answers on public consultation on implementation of transparency requirements of the European Clinical Trial Regulation<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Other\/2015\/01\/WC500180632.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-27-01-2015\/\">Press release<\/a><div class=\"content\"><p><strong>27.01.2015<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release on CHMP summary of positive opinion for Vantobra (tobramycin)<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Summary_of_opinion_-_Initial_authorisation\/human\/002633\/WC500167424.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-23-01-2015\/\">Press release<\/a><div class=\"content\"><p><strong>23.01.2015<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release on public consultation on application of transparency rules of EU Clinical Trial Regulation<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2015\/01\/WC500180636.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-16-12-2014\/\">Press release<\/a><div class=\"content\"><p><strong>16.12.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release: Experimental Ebola treatments still at early stage of  development<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/12\/WC500179060.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-09-12-2014\/\">Press release<\/a><div class=\"content\"><p><strong>09.12.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release on GVK Biosciences review: some Member States suspend marketing authorisations for concerned medicines<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/12\/WC500178489.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release\/\">Press release<\/a><div class=\"content\"><p><strong>02.12.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release: No evidence that Fluad vaccine caused deaths in Italy<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/12\/WC500177992.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-02-12-2014\/\">Press release<\/a><div class=\"content\"><p><strong>02.12.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release on Investigation into reports of serious adverse events following use of Fluad<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2014\/11\/news_detail_002226.jsp&#038;mid=WC0b01ac058004d5c1\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-26-11-2014\/\">Press release<\/a><div class=\"content\"><p><strong>26.11.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release: No consistent evidence of an increased risk of heart problems with testosterone medicines<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/11\/WC500177618.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-25-11-2014\/\">Press release<\/a><div class=\"content\"><p><strong>25.11.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release: CMDh agrees to strengthen warnings on the use of valproate medicines in women and girls<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/11\/WC500177638.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-12-11-2014\/\">Press release<\/a><div class=\"content\"><p><strong>12.11.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release: PRAC recommends measures to reduce risk of heart problems with Corlentor\/Procoralan (ivabradine)<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/11\/WC500177104.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-04-11-2014\/\">Press release<\/a><div class=\"content\"><p><strong>04.11.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release: European Medicines Agency recommends further measures to minimise risk of blood vessel blockage with Iclusig<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Iclusig_20\/Opinion_provided_by_Committee_for_Medicinal_Products_for_Human_Use\/WC500176328.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-29-10-2014\/\">Press release<\/a><div class=\"content\"><p><strong>29.10.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release: European Medicines Agency completes review of polymyxin-based medicines<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/10\/WC500176334.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-16-10-2014-2\/\">Press release<\/a><div class=\"content\"><p><strong>16.10.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release: PRAC recommends further measures to minimise risk of blood vessel blockage with Iclusig<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/10\/WC500175206.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-16-10-2014\/\">Press release<\/a><div class=\"content\"><p><strong>16.10.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release: PRAC recommends strengthening the restrictions on the use of valproate in women and girls<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/10\/WC500175208.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-14-10-2014\/\">Press release<\/a><div class=\"content\"><p><strong>14.10.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release: PRAC review does not confirm increase in heart problems with testosterone medicines<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/10\/WC500175207.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-08-10-2014\/\">Press release<\/a><div class=\"content\"><p><strong>08.10.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release: Information on suspected side effects of nationally authorised medicines now available through a single website<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/10\/WC500174806.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-03-10-2014-5\/\">Press release<\/a><div class=\"content\"><p><strong>03.10.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA confirms positive benefit-risk for antidepressant Valdoxan\/Thymanax (agomelatine)<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/09\/WC500173636.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-03-10-2014-4\/\">Press release<\/a><div class=\"content\"><p><strong>03.10.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEbola outbreak: EMA to review experimental medicines to support treatment decisions<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/09\/WC500173687.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-03-10-2014-3\/\">Press release<\/a><div class=\"content\"><p><strong>03.10.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release: Start of a review concerning the conduct of studies at GVK Biosciences site in Hyderabad, India<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/GVK_Biosciences_31\/WC500173714.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-03-10-2014-2\/\">Press release<\/a><div class=\"content\"><p><strong>03.10.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release on Closure of EU manufacturing site for MACI<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Maci_20\/WC500173680.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-03-10-2014\/\">Press release<\/a><div class=\"content\"><p><strong>03.10.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release: Ketoconazole HRA recommended for approval in Cushing&#8217;s syndrome<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/09\/WC500173638.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-27-08-2014\/\">Press release<\/a><div class=\"content\"><p><strong>27.08.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nCMDh endorses restricted use of bromocriptine for stopping breast milk production<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Bromocriptine_31\/Position_provided_by_CMDh\/WC500171671.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-01-08-2014-2\/\">Press release<\/a><div class=\"content\"><p><strong>01.08.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nCMDh endorses suspension of methadone oral solutions containing high molecular weight povidone<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/07\/WC500170053.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-01-08-2014\/\">Press release<\/a><div class=\"content\"><p><strong>01.08.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nLevonorgestrel and ulipristal remain suitable emergency contraceptives for all women, regardless of bodyweight<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/07\/WC500170056.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-15-07-2014-2\/\">Press release<\/a><div class=\"content\"><p><strong>15.07.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release: PRAC recommends suspension and reformulation of oral methadone solutions containing high molecular weight povidone<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Methadone\/Recommendation_provided_by_Pharmacovigilance_Risk_Assessment_Committee\/WC500169751.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-15-07-2014\/\">Press release<\/a><div class=\"content\"><p><strong>15.07.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release: PRAC recommends restricted use of bromocriptine-containing medicinal products<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Bromocriptine_31\/Recommendation_provided_by_Pharmacovigilance_Risk_Assessment_Committee\/WC500169746.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-17-06-2014\/\">Press release<\/a><div class=\"content\"><p><strong>17.06.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA starts review of ibuprofen medicines;<br \/>\nReview to evaluate cardiovascular risk with high doses taken over long periods<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/06\/WC500168436.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-28-05-2014\/\">Press release<\/a><div class=\"content\"><p><strong>28.05.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release on combined use of medicines affecting the renin-angiotensin system (RAS) to be restricted \u2013 CHMP endorses PRAC recommendation<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/05\/WC500167421.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-14-05-2014\/\">Press release<\/a><div class=\"content\"><p><strong>14.05.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release: Review of Corlentor\/Procoralan started<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/05\/WC500166318.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-13-05-2014\/\">Press release<\/a><div class=\"content\"><p><strong>13.05.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release: Review of hydroxyzine-containing medicines started<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/05\/WC500166308.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-05-05-2014-3\/\">Press release<\/a><div class=\"content\"><p><strong>05.05.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release: Review of adrenaline auto-injectors started<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Adrenaline_31\/WC500165690.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-05-05-2014-2\/\">Press release<\/a><div class=\"content\"><p><strong>05.05.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEuropean Medicines Agency recommendations on the use of Linoladiol N and Linoladiol HN estradiol-containing creams<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/04\/WC500165668.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-05-05-2014\/\">Press release<\/a><div class=\"content\"><p><strong>05.05.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release: CMDh confirms recommendations on restricting use of domperidone-containing medicines<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Domperidone_31\/Position_provided_by_CMDh\/WC500165647.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-30-04-2014\/\">Press release<\/a><div class=\"content\"><p><strong>30.04.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nCMDh endorses new advice to minimise risk of next-morning impaired driving ability and mental alertness with zolpidem<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Zolpidem-containing_medicinal_products\/Position_provided_by_CMDh\/WC500165639.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-29-04-2014\/\">Press release<\/a><div class=\"content\"><p><strong>29.04.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEuropean Medicines Agency recommends revoking authorisations of Caustinerf arsenical and Yranicid arsenical used in dental procedures<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Caustinerf-Yranicid\/WC500165672.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-23-04-2014\/\">Press release<\/a><div class=\"content\"><p><strong>23.04.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEuropean Medicines Agency update on stolen vials of Herceptin<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/04\/WC500165525.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-16-04-2014\/\">Press release<\/a><div class=\"content\"><p><strong>16.04.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEuropean Medicines Agency alerts EU healthcare professionals after vials of falsified Herceptin identified<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/04\/WC500165501.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-15-04-2014-5\/\">Press release<\/a><div class=\"content\"><p><strong>15.04.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release: PRAC recommends against combined use of medicines affecting the renin-angiotensin (RAS) system<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/04\/WC500165197.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-15-04-2014-4\/\">Press release<\/a><div class=\"content\"><p><strong>15.04.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release: Review of oral methadone medicines containing povidone started<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/04\/WC500165226.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-15-04-2014-3\/\">Press release<\/a><div class=\"content\"><p><strong>15.04.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release: Start of review of codeine-containing medicines when used for cough and cold in children<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/04\/WC500165242.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-15-04-2014-2\/\">Press release<\/a><div class=\"content\"><p><strong>15.04.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release: Start of review of ambroxol and bromhexine<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/04\/WC500165234.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-15-04-2014\/\">Press release<\/a><div class=\"content\"><p><strong>15.04.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release: Review of testosterone-containing medicines started<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/04\/WC500165222.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-26-03-2014\/\">Press release<\/a><div class=\"content\"><p><strong>26.03.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nCMDh endorses recommendations to restrict the use of diacerein-containing medicines<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Diacerein\/Position_provided_by_CMDh\/WC500163532.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-17-03-2014-3\/\">Press release<\/a><div class=\"content\"><p><strong>17.03.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release: PRAC recommends product information of zolpidem be updated with new advice to minimise the risk of next-morning impaired driving ability and mental alertness<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/03\/WC500162556.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-17-03-2014-2\/\">Press release<\/a><div class=\"content\"><p><strong>17.03.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release: PRAC recommends restricting use of domperidone<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/03\/WC500162558.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-17-03-2014\/\">Press release<\/a><div class=\"content\"><p><strong>17.03.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release: PRAC re-examines diacerein and recommends that it remain available with restrictions<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/03\/WC500162560.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-26-02-2014\/\">Press release<\/a><div class=\"content\"><p><strong>26.02.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of stakeholder<\/strong><\/span><br \/>\n<strong>NAMMD Press Release on the situation ensued from non-compliance of influenza seasonal vaccine batches  manufactured by the Cantacuzino Institute for 2013-2014<\/strong><\/p>\n<p>According to Article 826 of Law 95\/2006 on healthcare reform, as amended, Title  XVII \u2013 The medicinal product, transposing Directive 2001\/83\/CE of the European Parliament and the Council on the Community code relating to medicinal products for human use, as amended, the National Agency for Medicines and Medical Devices (NAMMD) is in charge of official batch release for immunologic or blood\/plasma-derived medicinal products manufactured in Romania, third countries or EU Member States for which official batch release has not been performed by a control authority and for which marketing is only performed in Romania.<br \/>\nSamples from all the eight batches of influenza vaccine manufactured by the Cantacuzino Institute have been tested in the NAMMD laboratories according to the corresponding monograph of the European Pharmacopoeia, in force. Following laboratory testing of samples submitted, out-of-specification results have been obtained for one of the tested parameters, i.e. Bacterial endotoxins for all samples tested. Mention should be made that, for all the other parameters tested, results have been within admitted limits. In consequence of the non-compliance found for all vaccine batches newly manufactured by the Cantacuzino Institute, re-testing of sample has been performed at the NAMMD site, followed by re-testing in the presence of the manufacturer.<br \/>\nResults found at re-testing at both the NAMMD site in the presence of Cantacuzino Institute representatives and at manufacturer\u2019s site, with NAMMD representatives, have confirmed the non-compliance found regarding content of Bacterial Endotoxins over the accepted limits (max 100 IU\/ vaccine dose). The method for testing of Bacterial Endotoxins content as indicated by the manufacturer and according to provisions of the European Pharmacopoeia monograph has been the gel-clot method (a qualitative method).<br \/>\nOn 23.12.2013, the NAMMD sent a notification letter to the Ministry of Health, to the attention of Minister Eugen Nicolaescu, on the non-compliance found, determining as a consequence the impossibility to perform official batch release of the Cantacuzino Institute manufactured vaccine batch and the need to issue a Non-compliance notice.<br \/>\nOn 24.12.2013, the Non-compliance notices were collected from the NAMMD headquarters by a representative of the Cantacuzino Institute.<br \/>\nHaving in mind the potential impact of this non-compliant result on the public concerning the national seasonal influenza immunisation plan 2013-2014, in the context of Cantacuzino Institute reinstatement of manufacture and its strategic importance for Romania as well as the determination that NAMMD laboratory testing results be without doubt, the NAMMD management has decided to send a vaccine sample to be tested in the certified OMCL (Official Medicines Control Laboratories) laboratory of the French competent authority. The sample submitted for testing was part of a sample taken according to procedure in force for testing in the NAMMD laboratory. The method used by the French laboratory for testing of the Bacterial Endotoxins content is a quantitative method also included in the European Pharmacopoeia for this parameter, i.e. the kinetic-chromogenic method.<br \/>\nOn 31.01.2014, the NAMMD received the first confirmation of the non-compliant result from the French laboratory concerning Bacterial Endotoxins content; on 05.02.2014, the result notified on 31.01.2014 was re-confirmed.<br \/>\nThe result received from the French competent authority practically confirmed the accuracy of the result issued by the NAMMD in its Non-compliance notices, once again highlighting, in quantitative terms this time, the Bacterial Endotoxins content, ascertained to exceed the limits specified in the European Pharmacopoeia, i.e. maximum 100 IU\/ vaccine dose.<br \/>\nTo conclude, the NAMMD has not performed official batch release of the new influenza vaccine batches manufactured by the Cantacuzino Institute, which once again proves that the Romanian competent authority actually fulfils its primary mission as guarantor of the quality of medicinal products for human use authorised for marketing in Romania, protecting and promoting public health.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-25-02-2014-2\/\">Press release<\/a><div class=\"content\"><p><strong>25.02.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEuropean Medicines Agency recommends that Protelos\/Osseor remain available but with further restrictions<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/02\/WC500161971.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-25-02-2014\/\">Press release<\/a><div class=\"content\"><p><strong>25.02.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEuropean Medicines Agency recommends restricting the use of methysergide-containing medicines<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/02\/WC500161952.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-18-02-2014\/\">Press release<\/a><div class=\"content\"><p><strong>18.02.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release: Review of emergency contraceptives started<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2014\/01\/WC500160116.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-17-01-2014\/\">Press release<\/a><div class=\"content\"><p><strong>17.01.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of stakeholder<\/strong><\/span><br \/>\nIn the past two days, Romanian television and written press representatives have displayed particular interest in the potential adverse reactions of Paracetamol, following an article from the US press. The article does not contribute with additional aspects to known information available in the package leaflet of all paracetamol-containing medicinal products in the European Union.<br \/>\nThe respective information refers to recommended usual doses, i.e. 1-2 tablets taken every 4 hours, as needed, the maximum recommended dose (4g for adults, 60 mg\/kg\/day divided into equal doses for children 6 to 12 years old), potential adverse reactions (skin rash, itching, low platelet count, agranulocytosis accompanied by unexpected pharyngitis and fever, liver impairment, renal colic. Elevated paracetamol doses and prolonged treatment may determine impaired renal function leading to chronic kidney failure.<br \/>\nProduct information also specifies the potential renal impairment risk when taking paracetamol with alcohol, or the risk of combining paracetamol with other medicinal products.<br \/>\nThis information is detailed, harmonised in the entire European Union and, as in all package leaflets, stresses that adverse reactions are an issue for all medicinal products, although they may not occur in all individuals.<br \/>\nThe NAMMD hereby points out the importance of compliance with recommended doses to ensure the health of all patients by avoiding, as much as possible, the occurrence of adverse reactions.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-14-01-2014-2\/\">Press release<\/a><div class=\"content\"><p><strong>14.01.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nOn 10 January 2013, the European Medicines Agency (EMA) issued a press release on the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) to suspend the use of strontium ranelate-containing medicines Protelos and Osseor.<br \/>\nThe PRAC conducted a review of the benefits of these medicinal products, as well as a review of their known risks (myocardial infarction, venous thromboembolism, severe cutaneous reactions) and concluded that the benefit-risk balance for these products is no longer positive, recommending that the use of Protelos\/Osseor be suspended until new data attesting a positive benefit-risk balance for a limited group of patients is available.<br \/>\nWhile in April 2013 the PRAC recommended the restriction in the use of strontium ranelate, following a routine assessment of its benefit-risk balance, in January 2014, following an in-depth review of its safety profile, the European Medicines Agency&#8217;s Pharmacovigilance Risk Assessment Committee recommended the suspension of its use in the treatment of osteoporosis.<br \/>\nAt this stage, until new data becomes available confirming usefulness of this product for a certain population segment is available and until issuance of a European Commission Decision based on the final opinion of EMA\u2019s Committee for Medicinal Products for Human Use (CHMP) to be formulated after its meeting of 20-23 January 2014, physicians are advised to take particular care when prescribing these medicinal products.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-14-01-2014\/\">Press release<\/a><div class=\"content\"><p><strong>14.01.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nPRAC recommends suspending use of Protelos\/Osseor (strontium ranelate)<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Protelos_and_Osseor\/Recommendation_provided_by_Pharmacovigilance_Risk_Assessment_Committee\/WC500159374.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-13-01-2014\/\">Press release<\/a><div class=\"content\"><p><strong>13.01.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nCHMP confirms PRAC recommendations on Kogenate Bayer\/Helixate NexGen<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Kogenate_Bayer_Helixate_NexGen_20\/Opinion_provided_by_Committee_for_Medicinal_Products_for_Human_Use\/WC500158680.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-08-01-2014-2\/\">Press release<\/a><div class=\"content\"><p><strong>08.01.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nThe European Medicines Agency recommends that estradiol-containing creams Linoladiol N and Linoladiol HN remain available<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2013\/12\/news_detail_002001.jsp&#038;mid=WC0b01ac058004d5c1\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-08-01-2014\/\">Press release<\/a><div class=\"content\"><p><strong>08.01.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nAcipimox only to be used as additional or alternative treatment to reduce high triglyceride levels<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2013\/12\/WC500158705.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-11-12-2013\/\">Press release<\/a><div class=\"content\"><p><strong>11.12.2013<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEMA press release: Further review of Iclusig started<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2013\/12\/WC500157081.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-10-12-2013\/\">Press release<\/a><div class=\"content\"><p><strong>10.12.2013<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nPRAC considers benefits of Kogenate Bayer\/Helixate NexGen outweigh risks in previously untreated patients<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2013\/12\/WC500157083.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-05-12-2013\/\">Press release<\/a><div class=\"content\"><p><strong>05.12.2013<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEuropean Medicines Agency recommends changes in use of leukaemia medicine Iclusig (ponatinib) in order to minimise risk of blood clots<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2013\/11\/WC500155451.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-02-12-2013\/\">Press release<\/a><div class=\"content\"><p><strong>02.12.2013<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEuropean Medicines Agency recommends restricting use of thiocolchicoside by mouth or injection<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2013\/11\/WC500155448.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-26-11-2013\/\">Press release<\/a><div class=\"content\"><p><strong>26.11.2013<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nBenefits of combined hormonal contraceptives (CHCs) continue to outweigh risks \u2013 CHMP endorses PRAC recommendation<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2013\/11\/WC500155455.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-20-11-2013\/\">Press release<\/a><div class=\"content\"><p><strong>20.11.2013<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEuropean Medicines Agency finalises review of medicines concerned by Roche pharmacovigilance inspection<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2013\/11\/WC500154739.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-18-11-2013\/\">Press release<\/a><div class=\"content\"><p><strong>18.11.2013<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>Press release<\/strong><\/span><br \/>\nPRAC updates on the risks of serious vascular occlusive events associated with cancer medicine Iclusig<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2013\/11\/WC500154025.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-14-11-2013-2\/\">Press release<\/a><div class=\"content\"><p><strong>14.11.2013<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nPRAC recommends using acipimox only as additional or alternative treatment to lower high triglyceride levels<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2013\/11\/WC500154014.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-14-11-2013\/\">Press release<\/a><div class=\"content\"><p><strong>14.11.2013<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<br \/>\n<\/strong><\/span><br \/>\nPRAC recommends suspension of diacerein-containing medicines<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2013\/11\/WC500154015.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-31-10-2013-2\/\">Press release<\/a><div class=\"content\"><p><strong>31.10.2013<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nRestrictions on use of medicines containing ergot derivatives<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Ergot_derivatives\/WC500144860.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-31-10-2013\/\">Press release<\/a><div class=\"content\"><p><strong>31.10.2013<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nEuropean Medicines Agency gives recommendations on the use of intravenous nicardipine<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2013\/10\/WC500153122.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-29-10-2013-4\/\">Press release<\/a><div class=\"content\"><p><strong>29.10.2013<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nRestrictions on use of short-acting beta-agonists in obstetric indications \u2013 CMDh endorses PRAC recommendations<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2013\/10\/WC500153130.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-29-10-2013-2\/\">Press release<\/a><div class=\"content\"><p><strong>29.10.2013<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nBatches of the insulin medicine NovoMix 30 FlexPen and Penfill to be recalled<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2013\/10\/WC500153147.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-29-10-2013\/\">Press release<\/a><div class=\"content\"><p><strong>29.10.2013<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nHydroxyethyl-starch solutions (HES) should no longer be used in patients with sepsis or burn injuries or in critically ill patients \u2013 CMDh endorses PRAC recommendations<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2013\/10\/WC500153125.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-25-10-2013\/\">Press release<\/a><div class=\"content\"><p><strong>25.10.2013<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nStart of review of valproate and related substances<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Valproate_and_related_substances_31\/Procedure_started\/WC500151970.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-16-10-2013-2\/\">Press release<\/a><div class=\"content\"><p><strong>16.10.2013<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nPRAC confirms that hydroxyethyl &#8211; starch solutions (HES) should no longer be used in patients with sepsis or burn injuries or in critically ill patients HES will be available in restricted patient populations.<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2013\/10\/WC500151964.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-16-10-2013\/\">Press release<\/a><div class=\"content\"><p><strong>16.10.2013<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nPRAC confirms that benefits of all combined hormonal contraceptives (CHCs) continue to outweigh risks Committee recommends that women and prescribers be better informed of the known risk of thromboembolism and alert for signs and symptoms.<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2013\/10\/WC500151960.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-31-07-2013\/\">Press release<\/a><div class=\"content\"><p><strong>31.07.2013<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>NAMMD press release<\/strong><\/span><br \/>\nPress Release of the National Agency for Medicines and Medical Devices on recall of batches T737E and U299B of SUTENT 50 mg, capsules<br \/>\n<a href=\"\/en\/_\/COMUNICATE%20DE%20PRESA\/CP_Sutent_EN.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-10-06-2013\/\">Press release<\/a><div class=\"content\"><p><strong>10.06.2013<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nNAMMD press release on market withdrawal, at wholesale distributor level, of CILEST 0.250mg\/0.035mg, tablets<br \/>\n<a href=\"\/en\/_\/COMUNICATE%20DE%20PRESA\/CP_CILEST_EN.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-01-02-2013\/\">Press release<\/a><div class=\"content\"><p><strong>01.02.2013<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nThe National Agency for Medicines and Medical Devices is reviewing the safety profile of \u201cDiane 35\u201d<br \/>\nThe National Agency for Medicines and Medical Devices advises physicians to explain patients the side effects of the medicinal product<br \/>\n<a href=\"\/en\/_\/COMUNICATE%20DE%20PRESA\/CP_Diane%2035_EN.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-07-05-2012\/\">Press release<\/a><div class=\"content\"><p><strong>07.05.2012<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested parties<\/strong><\/span><br \/>\nProject launch: \u201cNATIONAL E-LEARNING PLATFORM ON PHARMACEUTICAL REGULATION\u201c \u2013 co-financed from the Regional European Development Fund<br \/>\n<a href=\"\/en\/_\/COMUNICATE%20DE%20PRESA\/CP_e-learning_EN.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-10-01-2012\/\">Press release<\/a><div class=\"content\"><p><strong>10.01.2012<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested parties<\/strong><\/span><br \/>\nIn 2011, the National Agency for Medicines and Medical Devices (NAMMD) approved variation to marketing authorisation (MA) terms concerning the trivalent purified inactivated influenza vaccine (Marketing authorisation holder &#8211; INCDMI Cantacuzino) as regards its composition in accordance with composition approved by the World Health Organisation for the 2011\/2012 season.<br \/>\nFollowing NAMMD approval, the Cantacuzino Institute has performed monitoring and monthly reporting to the NAMMD of outcomes of tests for each viral strain strength of the three viral strengths included in the vaccine.<br \/>\nTo this date, monthly outcomes recorded have been within the approved quality parameters. The NAMMD has been informed from the latest tests performed on decrease in strength below the approved limit of one of the three viral strains in the vaccine composition.<br \/>\nThe non-compliance submitted to the Agency concerned 7 out of the 18 vaccine batches manufactured. At the same time, the Cantacuzino Institute informed the NAMMD about initiation of the procedure for discontinued use of the 7 batches affected in view of recall.<br \/>\nThe NAMMD provided prompt reply to the Cantacuzino Institute concerning measures required under such circumstances. Such measures mainly involve mandatory NAMMD information on vaccine amounts recalled as compared to those manufactured and distributed, respectively, for each non-compliant batch. At the same time, it is the MAH\u2019s obligation to destroy all amounts recalled, in compliance with legal provisions in the field.<br \/>\nThe NAMMD will further monitor outcomes submitted by the Cantacuzino Institute on quantitative composition of influenza vaccine batches.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/comunicat-de-presa-04-04-2011\/\">Press release<\/a><div class=\"content\"><p><strong>04.04.2011<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>NAMMD press release<\/strong><\/span><br \/>\nIn response to the TVR3 channel \u201cRIALITI SOC\u201d show, of 9 p.m., Saturday, 2 April 2011, to the attention of the National Television Directorate<br \/>\n<a href=\"\/en\/_\/COMUNICATE%20DE%20PRESA\/CP_rialiti_EN.pdf\" target=\"blank\">download document &#8230;<\/a><\/p>\n<\/div><\/li><\/ul><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":440,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-452","page","type-page","status-publish","hentry"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/452","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/comments?post=452"}],"version-history":[{"count":0,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/452\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/440"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=452"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}