• Press release

    10.07.2018
    To the attention of interested persons
    The 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.
    descarca documentul …

  • Press release

    13.03.2018
    To the attention of interested persons
    EMA press release: Prostate cancer medicine Xofigo must not be used with Zytiga and prednisone/prednisolone.
    http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2018/03/WC500245412.pdf

  • Press release

    09.03.2018
    To the attention of interested persons
    Press release: EMA recommends immediate suspension and recall of multiple sclerosis medicine Zinbryta.
    NAMMD mention: Zinbryta (daclizumab) is not marketed in Romania on publication of this press release.
    http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/03/news_detail_002920.jsp&mid=WC0b01ac058004d5c1

  • Press release

    07.03.2018
    To the attention of interested persons
    Given 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:
    The 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.
    In 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 „slightly inferior as opposed to that of similar products previously available on the pharmaceutical market, due to a smaller IgG and a bigger IgA content”.
    Moreover, the NAMMD states that this category of medicinal products – blood or plasma-derived medicinal products – 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.
    Considering 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’s 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’s quality.
    The 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.

  • Press release

    16.02.2018
    To the attention of interested persons
    The National Agency for Medicines and Medical Devices (NAMMD) had the honour to host the first workday of the 4th edition of the Patients’ School Masterclass, organised by the Health Policies Magazine and by the the Coalition of Organisations of patients with chronic diseases (COPAC).
    The following participants have replied to questions and manifested total openness toward efficient and constructive communication with patient associations:
    Conf. Univ. Dr. Diana Paun – State Counsellor, Presidential Administration
    Sorina Pintea – Minister of Health
    Dr. Octavian Alexandrescu – Secretary of State – Ministry of Health
    Dr. Alexandru Velicu – NAMMD President
    Razvan Vulcanescu – NHIH President
    Conf. Univ. Dr. Florin Buicu – President of the Health and Family Commission, Chamber of Deputies
    Emanuel-Gabriel Botnariu – member of the Commission for Public Health, Senate
    Romana Furtuna – Counsellor of the Minister of Health on the relationship with patient associations and NGOs.
    The 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.
    Once 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.
    The 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).
    As 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.
    To 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’s specific issues and of practical solutions for their resolution, and in order to promote an ethical, correct and transparent environment for communication.

  • Press release

    13.02.2018
    To the attention of interested persons
    EMA press release: PRAC recommends that the marketing authorisation of the painkiller flupirtine be withdrawn.
    download document …

  • Press release

    13.02.2018
    To the attention of interested persons
    The EMA Pharmacovigilance Risk Assessment Committee recommends new measures to avoid valproate exposure in pregnancy.
    download document …

  • Press release

    13.02.2018
    To the attention of interested persons
    PRAC recommends updating measures for pregnancy prevention during retinoid use.
    download document …

  • Press release

    13.02.2018
    To the attention of interested persons
    EMA press release: Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing.
    download document …

  • Press release

    13.02.2018
    To the attention of interested persons
    The NAMMD has the pleasure to notify all its stakeholders on receipt of the final assessment reports of the Agency’s 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.
    The 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.

  • Press release

    09.02.2018
    To the attention of interested persons
    A 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.
    The Meeting’s 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.
    The 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.
    Considering 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.
    According 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.

  • Press release

    30.01.2018
    To the attention of interested persons
    Hydroxyethyl-starch solutions for infusion to be suspended – CMDh endorses PRAC recommendation.
    download document …

  • Press release

    18.01.2018
    To the attention of interested persons
    PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market.
    download document …

  • Press release

    18.01.2018
    To the attention of interested persons
    The 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.
    NAMMD 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.

  • Press release

    16.01.2018
    To the attention of interested persons
    As a reply to the recent press article (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), 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’s activity.
    Both 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’s mission within the EU network of specific national authorities cannot be optimally fulfilled.
    Given 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.

  • Press release

    12.01.2018
    To the attention of interested persons
    In 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.
    download document …

  • Press release

    20.12.2017
    To the attention of interested persons
    Modified-release paracetamol-containing products to be suspended from EU market.
    download document …

  • Press release

    20.12.2017
    To the attention of interested persons
    EMA press release on updated recommendations for contraception in men and women taking mycophenolate medicines.
    download document …

  • Press release

    11.12.2017
    To the attention of interested persons
    PRAC confirms that modified-release paracetamol should be suspended from market.
    download document …

  • Press release

    11.12.2017
    To the attention of interested persons
    EMA starts review of Esmya for uterine fibroids.
    download document …

  • Press release

    11.12.2017
    To the attention of interested persons
    Warning about use of prostate cancer medicine Xofigo in combination with Zytiga and prednisone or prednisolone.
    download document …

  • Press release

    20.11.2017
    To the attention of interested persons
    Contribute to better medicinal product safety by reporting suspected adverse drug reactions!
    The National Agency for Medicines and Medical Devices (NAMMD) is launching the second social media campaign for the general public.
    download document …

  • Press release

    15.11.2017
    To the attention of interested persons
    EMA concludes review of Zinbryta and confirms further restrictions to reduce risk of liver damage.
    download document …

  • Press release

    03.11.2017
    To the attention of interested persons
    Review of flupirtine-containing medicines started.
    download document …

  • Press release

    01.11.2017
    To the attention of interested persons
    EMA starts new review of hydroxyethyl-starch containing medicines.
    download document …

  • Press release

    01.11.2017
    To the attention of interested persons
    PRAC recommends further restrictions for multiple sclerosis medicine Zinbryta due to risk of serious liver damage.
    download document …

  • Press release

    30.10.2017
    To the attention of interested persons
    NAMMD position in response to recent press allegations
    The 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: “To address the NMA and the ministry and to be sent home and be advised not to make a stir with one’s donations…. And it was not just our company to be turned down…”
    For 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:
    – 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
    – 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.
    Accordingly, donations have been accepted of medication containing psychotropic and narcotic drugs, necessary for fire in-patients.
    – 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;
    – 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.
    The NAMMD hereby points out its deep regret at the defamation of its work, ultimately so often unjustifiably engendering patients and the general public’s 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.

  • Press release

    10.10.2017
    To the attention of interested persons
    Countdown to launch of new EudraVigilance System: final preparations for change-over to new system underway for go live date on 22 November 2017
    download document …

  • Press release

    06.10.2017
    To the attention of interested persons
    EMA press release: PRAC recommends modified-release paracetamol be removed from market (update: 29 September 2017)
    download document …

  • Press release

    25.09.2017
    To the attention of interested persons
    EMA concludes review of human factor VIII medicines authorised in EU
    download document …

  • Press release

    11.09.2017
    To the attention of interested persons
    EMA press release: PRAC recommends modified-release paracetamol be removed from market
    download document …

  • Press release

    07.09.2017
    To the attention of interested persons
    PRAC confirms its previous conclusion on risk of inhibitor development with factor VIII medicines
    download document …

  • Press release

    16.08.2017
    To the attention of interested persons
    EMA seeks views of public during its safety review of valproate Registration opens for first public hearing
    download document …

  • Press release

    04.08.2017
    To the attention of interested persons
    CMDh confirms that methylprednisolone injections containing lactose must not be given to patients allergic to cow’s milk proteins
    download document …

  • Press release

    31.07.2017
    To the attention of interested persons
    EMA’s final opinion confirms restrictions on use of linear gadolinium agents in body scans – Recommendations conclude EMA’s scientific review of gadolinium deposition in brain and other tissues
    download document …

  • Press release

    11.07.2017
    To the attention of interested persons
    EMA restricts use of multiple sclerosis medicine Zinbryta
    download document …

  • Press release

    11.07.2017
    To the attention of interested persons
    PRAC recommends that injectable methylprednisolone products containing lactose must not be given to patients allergic to cow’s milk proteins
    download document …

  • Press release

    10.07.2017
    To the attention of interested persons
    PRAC confirms restrictions on the use of linear gadolinium agents
    download document …

  • Press release

    29.06.2017
    To the attention of interested persons
    EMA recommends that Symbioflor 2 can continue to be used for irritable bowel syndrome
    download document …

  • Press release

    14.06.2017
    To the attention of interested persons
    PRAC concludes there is no evidence of a change in known risk of neutropenic enterocolitis with docetaxel
    download document …

  • Press release

    13.06.2017
    To the attention of interested persons
    EMA reviews multiple sclerosis medicine Zinbryta
    download document …

  • Press release

    12.06.2017
    To the attention of interested persons
    PRAC concludes there is no clear and consistent evidence of a difference in inhibitor development between classes of factor VIII medicines
    download document …

  • Press release

    25.05.2017
    To the attention of interested persons
    Announcement of the EMA Management Board – Confirmation of full functionality of the EudraVigilance database
    download document …

  • Press release

    23.05.2017
    To the attention of interested persons
    EMA recommends changes to prescribing information for vancomycin antibiotics
    download document …

  • Press release

    12.05.2017
    To the attention of interested persons
    The NAMMD hereby informs on publication of the EMA annual report for 2016
    download document …

  • Press release

    12.05.2017
    To the attention of interested persons
    The 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.
    download document …

  • Press release

    09.05.2017
    To the attention of interested persons
    EMA press release: PRAC concludes there is no clear and consistent evidence of a difference in inhibitor development between classes of factor VIII medicines
    download document …

  • Press release

    12.04.2017
    To the attention of interested persons
    EMA concludes safety review of Uptravi
    download document …

  • Press release

    12.04.2017
    To the attention of interested persons
    PRAC concludes assessment of gadolinium agents used in body scans and recommends regulatory actions, including suspension for some marketing authorisations – Update of 7 Aprilie 2017
    download document …

  • Press release

    27.03.2017
    To the attention of interested persons
    EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs
    download document …

  • Press release

    14.03.2017
    To the attention of interested persons
    EMA press release: PRAC concludes assessment of gadolinium agents used in body scans and recommends regulatory actions, including suspension for some marketing authorisations
    download document …

  • Press release

    14.03.2017
    To the attention of interested persons
    EMA press release on new review of valproate use in pregnancy and women of childbearing age
    download document …

  • Press release

    14.03.2017
    To the attention of interested persons
    EMA reviewing cancer medicine docetaxel
    download document …

  • Press release

    06.03.2017
    To the attention of interested persons
    The 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.
    The 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.
    The 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.
    Teams 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.
    The 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’s Directorate General for Trade.

  • Press release

    27.02.2017
    To the attention of interested persons
    Ema press release on SGLT2 inhibitors: information on potential risk of toe amputation to be included in prescribing information
    download document …

  • Press release

    14.02.2017
    To the attention of interested persons
    EMA to review persistence of side effects known to occur with quinolone and fluoroquinolone antibiotics
    download document …

  • Press release

    14.02.2017
    To the attention of interested persons
    EMA reviewing safety of Uptravi for pulmonary arterial hypertension
    download document …

  • Press release

    14.02.2017
    To the attention of interested persons
    EMA press release: PRAC concludes that diabetes medicine canagliflozin may contribute to risk of toe amputation
    download document …

  • Press release

    01.02.2017
    To the attention of interested persons
    EMA press release: Dienogest/ethinylestradiol can be used for acne after certain other treatments have failed
    download document …

  • Press release

    18.01.2017
    To the attention of interested persons
    Considering 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 http://www.anm.ro/en/medicamente-de-uz-uman/publicitate/sponsorizari-medicamente-de-uz-uman/.

  • Press release

    21.12.2016
    To the attention of interested persons
    EMA press release on direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B
    download document …

  • Press release

    21.12.2016
    To the attention of interested persons
    EMA press release on start of a review concerning the conduct of studies at Micro Therapeutic Research Labs, India
    download document …

  • Press release

    08.12.2016
    To the attention of interested persons
    The 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 „Strengthening Collaboration for Operating Pharmacovigilance in Europe –SCOPE Joint Action”, financed by the European Union Health Programme.
    Reporting of suspected adverse reaction to medicinal products is important; it is the only way you can contribute to better medicinal product safety.

  • Press release

    08.12.2016
    To the attention of interested persons
    EMA press release: PRAC warns of risk of hepatitis B re-activation with direct-acting antivirals for hepatitis C
    download document …

  • Press release

    20.10.2016
    To the attention of interested persons
    Press release: EMA recommends measures to ensure safe use of Keppra oral solution
    download document …

  • Press release

    19.10.2016
    To the attention of interested persons
    EMA press release: Use of metformin to treat diabetes now expanded to patients with moderately reduced kidney function
    download document …

  • Press release

    21.09.2016
    To the attention of interested persons
    EMA press release: Pharmaceutics International Inc., US: supply of noncritical medicines to EU to be stopped due to manufacturing failings
    download document …

  • Press release

    09.08.2016
    To the attention of interested persons
    EMA 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
    download document …

  • Press release

    09.08.2016
    To the attention of interested persons
    EMA press release: EU collaboration strengthens safety monitoring of medicines
    download document …

  • Press release

    26.07.2016
    To the attention of interested persons
    EMA press release: CHMP confirms recommendations for use of Zydelig
    download document …

  • Press release

    26.07.2016
    To the attention of interested persons
    EMA recommends suspension of medicines over flawed studies at Semler Research Centre
    download document …

  • Press release

    17.07.2016
    To the attention of interested persons
    EMA press release: Proposals to revise guidance on first-in-human clinical trials
    download document …

  • Press release

    11.07.2016
    To the attention of interested persons
    EMA press release: Review of factor VIII medicines and risk of developing inhibitors in patients starting treatment for haemophilia A
    download document …

  • Press release

    11.07.2016
    To the attention of interested persons
    EMA press release: EMA starts review of retinoid medicines
    download document …

  • Press release

    11.07.2016
    To the attention of interested persons
    EMA press release: EMA to review modified-release paracetamol
    download document …

  • Press release

    11.07.2016
    To the attention of interested persons
    EMA press release: PRAC concludes review of Zydelig and issues updated recommendations for use
    download document …

  • Press release

    29.06.2016
    To the attention of interested persons
    EMA press release on start of review of medicines manufactured at Pharmaceutics International Inc., USA
    download document …

  • Press release

    29.06.2016
    To the attention of interested persons
    EMA press release: Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU
    download document …

  • Press release

    29.06.2016
    To the attention of interested persons
    EMA warns that Noxafil tablets and oral suspension have different doses and are not interchangeable
    download document …

  • Press release

    29.06.2016
    To the attention of interested persons
    EMA press release: Adempas not for use in patients with pulmonary hypertension caused by idiopathic interstitial pneumonia
    download document …

  • Press release

    15.06.2016
    To the attention of interested persons
    EMA press release: Single, central platform now mandatory for all periodic safety update reports
    download document …

  • Press release

    30.05.2016
    To the attention of interested persons
    EMA press release: Improving safety of first-in-human clinical trials
    download document …

  • Press release

    18.05.2016
    To the attention of interested persons
    EMA press release on inhibitor development in previously untreated patients with severe haemophilia A treated with recombinant factor VIII products
    download document …

  • Press release

    05.05.2016
    To the attention of interested persons
    EMA press release on start of a review on the conduct of studies at Semler Research Centre Private Ltd, Bangalore, India
    download document …

  • Press release

    05.05.2016
    To the attention of interested persons
    EMA press release on completion of review of inhaled corticosteroids for chronic obstructive pulmonary disease
    download document …

  • Press release

    20.04.2016
    To the attention of interested persons
    EMA press release: Listening to the public’s views on the safety of medicines
    download document …

  • Press release

    20.04.2016
    To the attention of interested persons
    Press release: EMA reviews direct-acting antivirals for hepatitis C
    download document …

  • Press release

    19.04.2016
    To the attention of interested persons
    Press release: EMA reviews diabetes medicine canagliflozin
    download document …

  • Press release

    04.04.2016
    To the attention of interested persons
    EMA press release on start of a review concerning the conduct of studies at the Alkem Laboratories Ltd site, Taloja, India
    download document …

  • Press release

    04.04.2016
    To the attention of interested persons
    EMA press release: Review of Symbioflor 2 started
    download document …

  • Press release

    04.04.2016
    To the attention of interested persons
    EMA press release: CMDh endorses revocation of authorisations for fusafungine sprays used to treat airway infections
    download document …

  • Press release

    01.04.2016
    To the attention of interested persons
    EMA press release: Review of vancomycin-containing medicines started
    download document …

  • Press release

    22.03.2016
    To the attention of interested persons
    EMA press release on review of gadolinium contrast agents used in MRI scans
    download document …

  • Press release

    22.03.2016
    To the attention of interested persons
    EMA press release: PRAC reviews known risk of pneumonia with inhaled corticosteroids for chronic obstructive pulmonary disease
    download document …

  • Press release

    21.03.2016
    To the attention of interested persons
    EMA press release on review of direct-acting antivirals for hepatitis C
    download document …

  • Press release

    21.03.2016
    To the attention of interested persons
    EMA press release on recommendation of new safety measures for Zydelig
    download document …

  • Press release

    02.03.2016
    To the attention of interested persons
    EMA confirms recommendations to minimise risk of brain infection PML with Tysabri
    download document …

  • Press release

    02.03.2016
    To the attention of interested persons
    EMA confirms recommendations to minimise ketoacidosis risk with SGLT2 inhibitors for diabetes
    download document …

  • Press release

    02.03.2016
    To the attention of interested persons
    EMA press release on start of review of medicines containing dienogest 2 mg and ethinylestradiol 0.03 mg for acne
    download document …

  • Press release

    17.02.2016
    To the attention of interested persons
    EMA press release on SGLT2 inhibitors: PRAC makes recommendations to minimise risk of diabetic ketoacidosis
    download document …

  • Press release

    17.02.2016
    To the attention of interested persons
    EMA press release on updated recommendations to minimise the risk of the rare brain infection PML with Tysabri
    download document …

  • Press release

    16.02.2016
    To the attention of interested persons
    EMA press release: PRAC recommends that fusafungine nose and mouth sprays are no longer marketed
    download document …

  • Press release

    09.02.2016
    To the attention of interested persons
    Press release: EMA concludes defective device in ROCKET study does not impact Xarelto’s safety
    download document …

  • Press release

    09.02.2016
    To the attention of interested persons
    Press release: EMA sets up task force on Zika virus
    download document …

  • Press release

    02.02.2016
    To the attention of interested persons
    EMA press release: Review of metformin-containing medicines started
    download document …

  • Press release

    29.12.2015
    To the attention of interested persons
    EMA 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)
    download document …

  • Press release

    24.11.2015
    To the attention of interested persons
    EMA press release on HPV vaccines: EMA confirms evidence does not support that they cause CRPS or POTS
    download document …

  • Press release

    06.11.2015
    To the attention of interested persons
    EMA press release: review concludes evidence does not support that HPV vaccines cause CRPS or POTS
    download document …

  • Press release

    28.10.2015
    To the attention of interested persons
    EMA press release on recommendation of additional measures to prevent use of mycophenolate in pregnancy
    download document …

  • Press release

    28.10.2015
    To the attention of interested persons
    EMA press release: Inductos to be suspended in the EU
    download document …

  • Press release

    28.10.2015
    To the attention of interested persons
    EMA press release on Updated recommendations to minimise the risk of the rare brain infection PML with Tecfidera
    download document …

  • Press release

    28.10.2015
    To the attention of interested persons
    EMA press release on updated advice on body fat changes and lactic acidosis with HIV medicines
    download document …

  • Press release

    14.09.2015
    To the attention of interested persons
    EMA press release on start of review of nasal and mouth sprays containing fusafungine
    download document …

  • Press release

    29.07.2015
    To the attention of interested persons
    Press release: EMA to review Inductos
    download document …

  • Press release

    14.07.2015
    To the attention of interested persons
    EMA press release: EMA to further clarify safety profile of human papillomavirus (HPV) vaccines
    download document …

  • Press release

    07.07.2015
    To the attention of interested persons
    EMA press release on improving safety of medicines across Europe
    download document …

  • Press release

    30.06.2015
    To the attention of interested persons
    EMA press release on better training tools recommended to support patients using adrenaline auto-injectors
    download document …

  • Press release

    16.06.2015
    To the attention of interested persons
    EMA press release on review of diabetes medicines called SGLT2 inhibitors started
    download document …

  • Press release

    27.05.2015
    To the attention of interested persons
    EMA press release on updated advice on use of high-dose ibuprofen
    download document …

  • Press release

    13.05.2015
    To the attention of interested persons
    EMA press release: review of Tysabri started
    download document …

  • Press release

    13.05.2015
    To the attention of interested persons
    EMA press release on start of review of inhaled corticosteroids for chronic obstructive pulmonary disease
    download document …

  • Press release

    28.04.2015
    To the attention of interested persons
    EMA press release: Codeine not to be used in children below 12 years for cough and cold
    download document …

  • Press release

    28.04.2015
    To the attention of interested persons
    EMA recommends avoidance of certain hepatitis C medicines and amiodarone together
    download document …

  • Press release

    16.04.2015
    To the attention of interested persons
    EMA press release on PRAC recommends updating advice on use of high-dose ibuprofen
    download document …

  • Press release

    31.03.2015
    To the attention of interested persons
    EMA press release on further measures to minimise risk of osteonecrosis of the jaw with bisphosphonate medicine
    download document …

  • Press release

    31.03.2015
    To the attention of interested persons
    EMA press release on new restrictions to minimise the risks of effects on heart rhythm with hydroxyzine-containing medicines
    download document …

  • Press release

    17.03.2015
    To the attention of interested persons
    EMA press release: PRAC recommends restrictions on the use of codeine for cough and cold in children
    download document …

  • Press release

    17.03.2015
    To the attention of interested persons
    EMA press release: PRAC recommends further measures to minimise risk of osteonecrosis of the jaw with bisphosphonate medicine
    download document …

  • Press release

    04.03.2015
    To the attention of interested persons
    The 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…
    download document …

  • Press release

    02.03.2015
    To the attention of healthcare professionals
    EMA press release: Ambroxol and bromhexine expectorants: safety information to be updated
    download document …

  • Press release

    24.02.2015
    To the attention of healthcare professionals
    The NAMMD hereby informs on results of tests conducted in NAMMD laboratories on samples of Imovax dT (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.
    No quality non-compliances have been detected and laboratory test results are compliant with manufacturer’s product specifications for the finished product and corresponding PhEur monograph from the European Pharmacopoeia.

  • Press release

    18.02.2015
    To the attention of healthcare professionals
    EMA press release: PRAC recommends new measures to minimise known heart risks of hydroxyzine-containing medicines
    download document …

  • Press release

    27.01.2015
    To the attention of healthcare professionals
    EMA press release on GVK Biosciences: European Medicines Agency recommends suspending medicines over flawed studies
    download document …

  • Press release

    27.01.2015
    To the attention of healthcare professionals
    Questions and answers on public consultation on implementation of transparency requirements of the European Clinical Trial Regulation
    download document …

  • Press release

    27.01.2015
    To the attention of healthcare professionals
    EMA press release on CHMP summary of positive opinion for Vantobra (tobramycin)
    download document …

  • Press release

    23.01.2015
    To the attention of healthcare professionals
    EMA press release on public consultation on application of transparency rules of EU Clinical Trial Regulation
    download document …

  • Press release

    16.12.2014
    To the attention of healthcare professionals
    EMA press release: Experimental Ebola treatments still at early stage of development
    download document …

  • Press release

    09.12.2014
    To the attention of healthcare professionals
    EMA press release on GVK Biosciences review: some Member States suspend marketing authorisations for concerned medicines
    download document …

  • Press release

    02.12.2014
    To the attention of healthcare professionals
    EMA press release: No evidence that Fluad vaccine caused deaths in Italy
    download document …

  • Press release

    02.12.2014
    To the attention of healthcare professionals
    EMA press release on Investigation into reports of serious adverse events following use of Fluad
    download document …

  • Press release

    26.11.2014
    To the attention of healthcare professionals
    EMA press release: No consistent evidence of an increased risk of heart problems with testosterone medicines
    download document …

  • Press release

    25.11.2014
    To the attention of healthcare professionals
    EMA press release: CMDh agrees to strengthen warnings on the use of valproate medicines in women and girls
    download document …

  • Press release

    12.11.2014
    To the attention of healthcare professionals
    EMA press release: PRAC recommends measures to reduce risk of heart problems with Corlentor/Procoralan (ivabradine)
    download document …

  • Press release

    04.11.2014
    To the attention of healthcare professionals
    EMA press release: European Medicines Agency recommends further measures to minimise risk of blood vessel blockage with Iclusig
    download document …

  • Press release

    29.10.2014
    To the attention of healthcare professionals
    EMA press release: European Medicines Agency completes review of polymyxin-based medicines
    download document …

  • Press release

    16.10.2014
    To the attention of healthcare professionals
    EMA press release: PRAC recommends further measures to minimise risk of blood vessel blockage with Iclusig
    download document …

  • Press release

    16.10.2014
    To the attention of healthcare professionals
    EMA press release: PRAC recommends strengthening the restrictions on the use of valproate in women and girls
    download document …

  • Press release

    14.10.2014
    To the attention of healthcare professionals
    EMA press release: PRAC review does not confirm increase in heart problems with testosterone medicines
    download document …

  • Press release

    08.10.2014
    To the attention of healthcare professionals
    EMA press release: Information on suspected side effects of nationally authorised medicines now available through a single website
    download document …

  • Press release

    03.10.2014
    To the attention of healthcare professionals
    EMA confirms positive benefit-risk for antidepressant Valdoxan/Thymanax (agomelatine)
    download document …

  • Press release

    03.10.2014
    To the attention of healthcare professionals
    Ebola outbreak: EMA to review experimental medicines to support treatment decisions
    download document …

  • Press release

    03.10.2014
    To the attention of healthcare professionals
    EMA press release: Start of a review concerning the conduct of studies at GVK Biosciences site in Hyderabad, India
    download document …

  • Press release

    03.10.2014
    To the attention of healthcare professionals
    EMA press release on Closure of EU manufacturing site for MACI
    download document …

  • Press release

    03.10.2014
    To the attention of healthcare professionals
    EMA press release: Ketoconazole HRA recommended for approval in Cushing’s syndrome
    download document …

  • Press release

    27.08.2014
    To the attention of healthcare professionals
    CMDh endorses restricted use of bromocriptine for stopping breast milk production
    download document …

  • Press release

    01.08.2014
    To the attention of healthcare professionals
    CMDh endorses suspension of methadone oral solutions containing high molecular weight povidone
    download document …

  • Press release

    01.08.2014
    To the attention of healthcare professionals
    Levonorgestrel and ulipristal remain suitable emergency contraceptives for all women, regardless of bodyweight
    download document …

  • Press release

    15.07.2014
    To the attention of healthcare professionals
    EMA press release: PRAC recommends suspension and reformulation of oral methadone solutions containing high molecular weight povidone
    download document …

  • Press release

    15.07.2014
    To the attention of healthcare professionals
    EMA press release: PRAC recommends restricted use of bromocriptine-containing medicinal products
    download document …

  • Press release

    17.06.2014
    To the attention of healthcare professionals
    EMA starts review of ibuprofen medicines;
    Review to evaluate cardiovascular risk with high doses taken over long periods
    download document …

  • Press release

    28.05.2014
    To the attention of healthcare professionals
    EMA press release on combined use of medicines affecting the renin-angiotensin system (RAS) to be restricted – CHMP endorses PRAC recommendation
    download document …

  • Press release

    14.05.2014
    To the attention of healthcare professionals
    EMA press release: Review of Corlentor/Procoralan started
    download document …

  • Press release

    13.05.2014
    To the attention of healthcare professionals
    EMA press release: Review of hydroxyzine-containing medicines started
    download document …

  • Press release

    05.05.2014
    To the attention of healthcare professionals
    EMA press release: Review of adrenaline auto-injectors started
    download document …

  • Press release

    05.05.2014
    To the attention of healthcare professionals
    European Medicines Agency recommendations on the use of Linoladiol N and Linoladiol HN estradiol-containing creams
    download document …

  • Press release

    05.05.2014
    To the attention of healthcare professionals
    EMA press release: CMDh confirms recommendations on restricting use of domperidone-containing medicines
    download document …

  • Press release

    30.04.2014
    To the attention of healthcare professionals
    CMDh endorses new advice to minimise risk of next-morning impaired driving ability and mental alertness with zolpidem
    download document …

  • Press release

    29.04.2014
    To the attention of healthcare professionals
    European Medicines Agency recommends revoking authorisations of Caustinerf arsenical and Yranicid arsenical used in dental procedures
    download document …

  • Press release

    23.04.2014
    To the attention of healthcare professionals
    European Medicines Agency update on stolen vials of Herceptin
    download document …

  • Press release

    16.04.2014
    To the attention of healthcare professionals
    European Medicines Agency alerts EU healthcare professionals after vials of falsified Herceptin identified
    download document …

  • Press release

    15.04.2014
    To the attention of healthcare professionals
    EMA press release: PRAC recommends against combined use of medicines affecting the renin-angiotensin (RAS) system
    download document …

  • Press release

    15.04.2014
    To the attention of healthcare professionals
    EMA press release: Review of oral methadone medicines containing povidone started
    download document …

  • Press release

    15.04.2014
    To the attention of healthcare professionals
    EMA press release: Start of review of codeine-containing medicines when used for cough and cold in children
    download document …

  • Press release

    15.04.2014
    To the attention of healthcare professionals
    EMA press release: Start of review of ambroxol and bromhexine
    download document …

  • Press release

    15.04.2014
    To the attention of healthcare professionals
    EMA press release: Review of testosterone-containing medicines started
    download document …

  • Press release

    26.03.2014
    To the attention of healthcare professionals
    CMDh endorses recommendations to restrict the use of diacerein-containing medicines
    download document …

  • Press release

    17.03.2014
    To the attention of healthcare professionals
    EMA 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
    download document …

  • Press release

    17.03.2014
    To the attention of healthcare professionals
    EMA press release: PRAC recommends restricting use of domperidone
    download document …

  • Press release

    17.03.2014
    To the attention of healthcare professionals
    EMA press release: PRAC re-examines diacerein and recommends that it remain available with restrictions
    download document …

  • Press release

    26.02.2014
    To the attention of stakeholder
    NAMMD Press Release on the situation ensued from non-compliance of influenza seasonal vaccine batches manufactured by the Cantacuzino Institute for 2013-2014

    According to Article 826 of Law 95/2006 on healthcare reform, as amended, Title XVII – 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.
    Samples 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.
    Results found at re-testing at both the NAMMD site in the presence of Cantacuzino Institute representatives and at manufacturer’s 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).
    On 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.
    On 24.12.2013, the Non-compliance notices were collected from the NAMMD headquarters by a representative of the Cantacuzino Institute.
    Having 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.
    On 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.
    The 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.
    To 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.

  • Press release

    25.02.2014
    To the attention of healthcare professionals
    European Medicines Agency recommends that Protelos/Osseor remain available but with further restrictions
    download document …

  • Press release

    25.02.2014
    To the attention of healthcare professionals
    European Medicines Agency recommends restricting the use of methysergide-containing medicines
    download document …

  • Press release

    18.02.2014
    To the attention of healthcare professionals
    EMA press release: Review of emergency contraceptives started
    download document …

  • Press release

    17.01.2014
    To the attention of stakeholder
    In 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.
    The 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.
    Product information also specifies the potential renal impairment risk when taking paracetamol with alcohol, or the risk of combining paracetamol with other medicinal products.
    This 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.
    The 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.

  • Press release

    14.01.2014
    To the attention of healthcare professionals
    On 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.
    The 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.
    While 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’s Pharmacovigilance Risk Assessment Committee recommended the suspension of its use in the treatment of osteoporosis.
    At 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’s 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.

  • Press release

    14.01.2014
    To the attention of healthcare professionals
    PRAC recommends suspending use of Protelos/Osseor (strontium ranelate)
    download document …

  • Press release

    13.01.2014
    To the attention of healthcare professionals
    CHMP confirms PRAC recommendations on Kogenate Bayer/Helixate NexGen
    download document …

  • Press release

    08.01.2014
    To the attention of healthcare professionals
    The European Medicines Agency recommends that estradiol-containing creams Linoladiol N and Linoladiol HN remain available
    download document …

  • Press release

    08.01.2014
    To the attention of healthcare professionals
    Acipimox only to be used as additional or alternative treatment to reduce high triglyceride levels
    download document …

  • Press release

    11.12.2013
    To the attention of healthcare professionals
    EMA press release: Further review of Iclusig started
    download document …

  • Press release

    10.12.2013
    To the attention of healthcare professionals
    PRAC considers benefits of Kogenate Bayer/Helixate NexGen outweigh risks in previously untreated patients
    download document …

  • Press release

    05.12.2013
    To the attention of healthcare professionals
    European Medicines Agency recommends changes in use of leukaemia medicine Iclusig (ponatinib) in order to minimise risk of blood clots
    download document …

  • Press release

    02.12.2013
    To the attention of healthcare professionals
    European Medicines Agency recommends restricting use of thiocolchicoside by mouth or injection
    download document …

  • Press release

    26.11.2013
    To the attention of healthcare professionals
    Benefits of combined hormonal contraceptives (CHCs) continue to outweigh risks – CHMP endorses PRAC recommendation
    download document …

  • Press release

    20.11.2013
    To the attention of healthcare professionals
    European Medicines Agency finalises review of medicines concerned by Roche pharmacovigilance inspection
    download document …

  • Press release

    18.11.2013
    Press release
    PRAC updates on the risks of serious vascular occlusive events associated with cancer medicine Iclusig
    download document …

  • Press release

    14.11.2013
    To the attention of healthcare professionals
    PRAC recommends using acipimox only as additional or alternative treatment to lower high triglyceride levels
    download document …

  • Press release

    14.11.2013
    To the attention of healthcare professionals

    PRAC recommends suspension of diacerein-containing medicines
    download document …

  • Press release

    31.10.2013
    To the attention of healthcare professionals
    Restrictions on use of medicines containing ergot derivatives
    download document …

  • Press release

    31.10.2013
    To the attention of healthcare professionals
    European Medicines Agency gives recommendations on the use of intravenous nicardipine
    download document …

  • Press release

    29.10.2013
    To the attention of healthcare professionals
    Restrictions on use of short-acting beta-agonists in obstetric indications – CMDh endorses PRAC recommendations
    download document …

  • Press release

    29.10.2013
    To the attention of healthcare professionals
    Batches of the insulin medicine NovoMix 30 FlexPen and Penfill to be recalled
    download document …

  • Press release

    29.10.2013
    To the attention of healthcare professionals
    Hydroxyethyl-starch solutions (HES) should no longer be used in patients with sepsis or burn injuries or in critically ill patients – CMDh endorses PRAC recommendations
    download document …

  • Press release

    25.10.2013
    To the attention of healthcare professionals
    Start of review of valproate and related substances
    download document …

  • Press release

    16.10.2013
    To the attention of healthcare professionals
    PRAC confirms that hydroxyethyl – 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.
    download document …

  • Press release

    16.10.2013
    To the attention of healthcare professionals
    PRAC 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.
    download document …

  • Press release

    31.07.2013
    NAMMD press release
    Press Release of the National Agency for Medicines and Medical Devices on recall of batches T737E and U299B of SUTENT 50 mg, capsules
    download document …

  • Press release

    10.06.2013
    To the attention of healthcare professionals
    NAMMD press release on market withdrawal, at wholesale distributor level, of CILEST 0.250mg/0.035mg, tablets
    download document …

  • Press release

    01.02.2013
    To the attention of healthcare professionals
    The National Agency for Medicines and Medical Devices is reviewing the safety profile of “Diane 35”
    The National Agency for Medicines and Medical Devices advises physicians to explain patients the side effects of the medicinal product
    download document …

  • Press release

    07.05.2012
    To the attention of interested parties
    Project launch: “NATIONAL E-LEARNING PLATFORM ON PHARMACEUTICAL REGULATION“ – co-financed from the Regional European Development Fund
    download document …

  • Press release

    10.01.2012
    To the attention of interested parties
    In 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 – INCDMI Cantacuzino) as regards its composition in accordance with composition approved by the World Health Organisation for the 2011/2012 season.
    Following 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.
    To 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.
    The 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.
    The 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’s obligation to destroy all amounts recalled, in compliance with legal provisions in the field.
    The NAMMD will further monitor outcomes submitted by the Cantacuzino Institute on quantitative composition of influenza vaccine batches.

  • Press release

    04.04.2011
    NAMMD press release
    In response to the TVR3 channel “RIALITI SOC” show, of 9 p.m., Saturday, 2 April 2011, to the attention of the National Television Directorate
    download document …