{"id":3720,"date":"2017-03-10T12:43:36","date_gmt":"2017-03-10T12:43:36","guid":{"rendered":"http:\/\/wwwro.anm.ro\/?page_id=3720"},"modified":"2026-06-09T14:44:51","modified_gmt":"2026-06-09T11:44:51","slug":"intrebari-si-raspunsuri-referitoare-la-siguranta-medicamentelor","status":"publish","type":"page","link":"https:\/\/www.anm.ro\/en\/medicamente-de-uz-uman\/farmacovigilenta\/intrebari-si-raspunsuri-referitoare-la-siguranta-medicamentelor\/","title":{"rendered":"Questions and answers on medicinal product safety"},"content":{"rendered":"\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
Questions and answers on the PSUR Repository and on the manner of transmitting Periodic Safety Update Reports (PSURs).
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Questions and answers on the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) on Diane 35
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Questions and answers on the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) on withdrawal of oral medicinal products containing almitrine
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Questions and answers on the supply shortage with Increlex (mecasermin)
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Questions and answers on the supply with Caelyx (doxorubicin hydrochloride)
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Questions and answers on medicinal products subject to additional monitoring
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Questions and answers on the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) on restricting the use of Protelos and Osseor
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Questions and answers on the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) for suspension of marketing authorisations for medicinal products containing tetrazepam
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Questions and answers on the shortage of Vistide (cidofovir)
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Questions and answers – PRAC considers that benefit-risk balance of Tredaptive, Pelzont and Trevaclyn (nicotinic acid\/laropiprant) is negative
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Questions and answers on the review the fibrin sealants Tisseel, Tissucol, Artiss and Beriplast P (and associated names), given by spray application
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Questions and answers on the review of medicinal products subject to trials conducted at the research base of Cetero, Texas, USA
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Questions and answers on the review of calcitonin-containing medicinal products
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Questions and answers on the review the fibrin sealants Evicel and Quixil, given by spray application<\/p>\n

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Questions and answers on the investigation of deficiencies in the medicine-safety reporting system of Roche
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Questions and answers on the review of\u00a0non-selective non-steroidal anti-inflammatory drugs (NSAIDs) and cardiovascular risk
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Questions and answers on the review of tolperisone-containing medicines
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Questions and answers on the review of medicinal products subject to trials conducted at the research base of Cetero, Texas, USA
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Questions and answers on the lack of sterility assurance with DepoCyte\u00a0(cytarabine)<\/p>\n

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Questions and answers on the review of Conbriza (bazedoxifene), PecFent (fentanyl) and Torisel (temsirolimus)
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Questions and answers on the review of Preflucel and associated names (influenza vaccine, purified antigen)
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Questions and answers on the review of calcitonin-containing medicines
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Questions and answers on the review of centrally authorised medicines with ingredients manufactured at Roche Carolina Inc., Florence, USA
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Questions and answers on the review of medicines containing trimetazidine
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Questions and answers on the review of medicines containing trimetazidine
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Questions and answers on the review of medicines containing tolperisone
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Questions and answers on the website dedicated to the European database of adverse reaction reports
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Questions and answers on the review of MabThera (rituximab)
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Questions and answers on the review of bleeding risk with Pradaxa\u00a0(dabigatran etexilate)
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Questions and answers on the review of Gilenya (fingolimod)
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Questions and answers on the review of Protelos and Osseor (strontium ranelate)
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Questions and answers on final recommendations on Caelyx and Ceplene manufactured at Ben Venue Laboratories
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Questions and answers on the supply shortage of Vfend (voriconazole)
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Questions and answers on the final recommendations on 12 centrally authorised medicines manufactured at Ben Venue Laboratories
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Questions and answers on the review of Vivaglobin (human normal immunoglobulin, solution for injection under the skin)
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Questions and answers on the expression of the strength for Halaven (eribulin)
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Questions and answers on the review aliskiren-containing medicine
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Questions and answers on the review of orlistat-containing medicines
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Questions and answers on the review of antifibrinolytic medicines (aprotinin, aminocaproic acid and tranexamic acid)
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Questions and answers on drug interactions between Victrelis (boceprevir) and ritonavir-boosted HIV protease inhibitors
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Questions and answers on recommendations to prevent administration errors with Velcade (bortezomib)
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Questions and answers on the review of Gilenya (fingolimod)
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Questions and answers on the suspension of the marketing authorisations for oral meprobamate-containing medicines
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Questions and answers on ongoing review of aliskiren-containing medicines
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Questions and answers on shortcomings in quality assurance at Ben Venue Laboratories
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Questions and answers on the review of somatropin-containing medicines
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Questions and answers on the use of Caelyx
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Questions and answers on the review of the marketing authorisations for medicines containing pholcodine<\/p>\n

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Questions and answers on the suspension of buflomedil-containing medicines
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Questions and answers on the review of angiotensin II receptor antagonists and the risk of cancer
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Questions and answers on the shortage of Apidra (insulin glulisine) cartridges
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Questions and answers on endotoxins in dialysis solutions produced at Baxter
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Questions and answers on the review of suppositories containing\u00a0terpenic\u00a0derivatives
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Questions and answers on the review of Revlimid (lenalidomide)
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Questions and answers on the review of Multaq (dronedarone)
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Questions and answers on the review of Vimpat 15 mg\/ml syrup (lacosamide)
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Questions and answers on the supply shortage with Caelyx (doxorubicin hydrochloride)
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Questions and answers on the likely shortage of Caelyx (doxorubicin hydrochloride).
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Questions and answers on the review of Pandemrix influenza vaccine\u00a0(H1N1)
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Questions and answers on the recall of Vimpat 15mg\/ml syrup (lacosamide)
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Questions and answers on the review of pioglitazone-containing medicines (Actos, Glustin, Competact, Glubrava and Tandemact)<\/p>\n

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Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg<\/p>\n

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Questions and answers on the review of systemic medicines containing nimesulide
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Questions and answers on the suspension of buflomedil-containing medicines
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Questions and answers on\u00a0the potential\u00a0off-label use of celecoxib in patients with familial adenomatous polyposis
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Questions and answers on the review of bisphosphonates and atypical stress fractures
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Questions and answers on the recommendation to lift the suspension of Octagam (human normal immunoglobulin 5% and 10%)
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Questions and answers on the review of Tygacil (tigecycline)
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Questions and answers on the supply shortage of Simponi 50 mg solution for injection in pre-filled pen
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Questions and answers on the review of Zerit (stavudine)
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Questions and answers on the possible risk of liver injury with Multaq (dronedarone)
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Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant<\/p>\n

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Questions and answers on the PSUR Repository and on the manner of transmitting Periodic Safety Update Reports (PSURs). download document […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":1074,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-3720","page","type-page","status-publish","hentry"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/3720","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=3720"}],"version-history":[{"count":3,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/3720\/revisions"}],"predecessor-version":[{"id":12167,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/3720\/revisions\/12167"}],"up":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/1074"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=3720"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}