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Questions and answers on medicinal product safety

Questions and answers on the PSUR Repository and Periodic Safety Update Report submission
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PRAC recommendations on Diane 35
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PRAC recommends withdrawal of oral almitrine-containing medicines
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Questions and answers on the shortage of Increlex (mecasermin)
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Questions and answers on the supply situation of Caelyx
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List of medicinal products under additional monitoring
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Medicines under additional monitoring
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PRAC recommends restriction in the use of Protelos/Osseor
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Tetrazepam-containing medicines Article-107i procedure – PRAC recommends suspension of tetrazepam-containing medicines: Questions and answers
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Questions and answers on the shortage of Vistide
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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 of 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 medicines for which studies have been conducted at Texas-based Cetero Research facility
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Questions and answers on the reassessment of the medicinal products that contain calcitonin
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Questions and answers on the review of the fibrin sealants Evicel and Quixil given by spray application
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Questions and answers on the assessment of the deficiencies in the safety reporting system at Roche Registration Ltd.
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Questions and answers on the review of non-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 medicines for which studies have been conducted at Texas-based Cetero Research facility
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Questions and answers on the lack of sterility assurance with DepoCyte (cytarabine)
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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 related to the review of the medicinal products that contain calcitonin
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Questions and answers on the review of centrally authorised medicines with ingredients manufactured at Roche Carolina Inc., Florence, United States
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Questions and answers on the review of medicines containing trimetazidine (20 mg tablets, 35 mg modified release tablet and 20 mg/ml oral solution)
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Questions and answers on the review of Doribax (doripenem)
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Questions and answers on the review of tolperisone-containing medicines
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Question and answer document on the European database of adverse drug reaction reports website
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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 (dabigatran etexilate)
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Questions and answers on the ongoing 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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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 of aliskiren-containing medicines
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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 ongoing 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 the review 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 related to the revaluation of the market authorizations for the medicinal products that contain folcodine
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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 shortage of Apidra (insulin glulisine) cartridges
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Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant
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Questions and answers on the review of suppositories that containing terpenic derivatives
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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 (lacosamide) 15-mg/ml syrup
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Questions and answers on likely shortage of Caelyx (doxorubicin hydrochloride)
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Questions and answers on the review of Pandemrix influenza vaccine (H1N1) (split virion, inactivated, adjuvanted) A/California/7/2009 (H1N1)v like strain (X-179A)
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Questions and answers on the recall of Vimpat 15-mg/ml syrup (lacosamide)
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Questions and answers on the review of pioglitazone-containing medicines (Actos, Glustin, Competact, Glubrava and Tandemact)
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Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg
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Questions and answers on the review of systemic medicines containing nimesulide
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Questions and answers related to the suspension of the use of the medicinal products with oral administration that contain buflomedil
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Questions and answers on the potential off-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 pre-filled pens
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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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