| Questions and answers on the PSUR Repository and Periodic Safety Update Report submission download document…  |
| PRAC recommendations on Diane 35 download document… |
| PRAC recommends withdrawal of oral almitrine-containing medicines download document… |
| Questions and answers on the shortage of Increlex (mecasermin) download document… |
| Questions and answers on the supply situation of Caelyx download document… |
| List of medicinal products under additional monitoring download document… |
| Medicines under additional monitoring download document… |
| PRAC recommends restriction in the use of Protelos/Osseor download document… |
| Tetrazepam-containing medicines Article-107i procedure – PRAC recommends suspension of tetrazepam-containing medicines: Questions and answers download document… |
| Questions and answers on the shortage of Vistide download document… |
| PRAC considers that benefit-risk balance of Tredaptive, Pelzont and Trevaclyn (nicotinic acid/laropiprant) is negative download document… |
| Questions and answers on the review of the fibrin sealants Tisseel, Tissucol, Artiss and Beriplast P (and associated names) given by spray application download document… |
| Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility download document… |
| Questions and answers on the reassessment of the medicinal products that contain calcitonin download document… |
| Questions and answers on the review of the fibrin sealants Evicel and Quixil given by spray application download document… |
| Questions and answers on the assessment of the deficiencies in the safety reporting system at Roche Registration Ltd. download document… |
| Questions and answers on the review of non-selective non-steroidal anti-inflammatory drugs (NSAIDs) and cardiovascular risk download document… |
| Questions and answers on the review of tolperisone-containing medicines download document… |
| Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility download document… |
| Questions and answers on the lack of sterility assurance with DepoCyte (cytarabine) download document… |
| Questions and answers on the review of Conbriza (bazedoxifene), PecFent (fentanyl) and Torisel (temsirolimus) download document… |
| Questions and answers on the review of Preflucel and associated names (influenza vaccine, purified antigen) download document… |
| Questions and answers related to the review of the medicinal products that contain calcitonin download document… |
| Questions and answers on the review of centrally authorised medicines with ingredients manufactured at Roche Carolina Inc., Florence, United States download document… |
| Questions and answers on the review of medicines containing trimetazidine (20 mg tablets, 35 mg modified release tablet and 20 mg/ml oral solution) download document… |
| Questions and answers on the review of Doribax (doripenem) download document… |
| Questions and answers on the review of tolperisone-containing medicines download document… |
| Question and answer document on the European database of adverse drug reaction reports website download document… |
| Questions and answers on the review of MabThera (rituximab) download document… |
| Questions and answers on the review of bleeding risk with Pradaxa (dabigatran etexilate) download document… |
| Questions and answers on the ongoing review of Gilenya (fingolimod) download document… |
| Questions and answers on the review of Protelos and Osseor (strontium ranelate) download document… |
| Questions and answers on final recommendations on Caelyx and Ceplene manufactured at Ben Venue Laboratories download document… |
| Questions and answers on the supply shortage of Vfend (voriconazole) download document… |
| Final recommendations on 12 centrally authorised medicines manufactured at Ben Venue Laboratories download document… |
| Questions and answers on the review of Vivaglobin (human normal immunoglobulin, solution for injection under the skin) download document… |
| Questions and answers on the expression of the strength for Halaven (eribulin) download document… |
| Questions and answers on the review of aliskiren-containing medicines download document… |
| Questions and answers on the review of orlistat-containing medicines download document… |
| Questions and answers on the review of antifibrinolytic medicines (aprotinin, aminocaproic acid and tranexamic acid) download document… |
| Questions and answers on drug interactions between Victrelis (boceprevir) and ritonavir-boosted HIV protease inhibitors download document… |
| Questions and answers on recommendations to prevent administration errors with Velcade (bortezomib) download document… |
| Questions and answers on the ongoing review of Gilenya (fingolimod) download document… |
| Questions and answers on the suspension of the marketing authorisations for oral meprobamate-containing medicines download document… |
| Questions and answers on the review aliskiren-containing medicines download document… |
| Questions and answers on shortcomings in quality assurance at Ben Venue Laboratories download document… |
| Questions and answers on the review of somatropin-containing medicines download document… |
| Questions and answers on the use of Caelyx download document… |
| Questions and answers related to the revaluation of the market authorizations for the medicinal products that contain folcodine download document… |
| Questions and answers on the suspension of buflomedil-containing medicines download document… |
| Questions and answers on the review of angiotensin-II-receptor antagonists and the risk of cancer download document… |
| Questions and answers on shortage of Apidra (insulin glulisine) cartridges download document… |
| Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant download document… |
| Questions and answers on the review of suppositories that containing terpenic derivatives download document… |
| Questions and answers on the review of Revlimid (lenalidomide) download document… |
| Questions and answers on the review of Multaq (dronedarone) download document… |
| Questions and answers on the review of Vimpat (lacosamide) 15-mg/ml syrup download document… |
| Questions and answers on likely shortage of Caelyx (doxorubicin hydrochloride) download document… |
| 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) download document… |
| Questions and answers on the recall of Vimpat 15-mg/ml syrup (lacosamide) download document… |
| Questions and answers on the review of pioglitazone-containing medicines (Actos, Glustin, Competact, Glubrava and Tandemact) download document… |
| Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg download document… |
| Questions and answers on the review of systemic medicines containing nimesulide download document… |
| Questions and answers related to the suspension of the use of the medicinal products with oral administration that contain buflomedil download document… |
| Questions and answers on the potential off-label use of celecoxib in patients with familial adenomatous polyposis download document… |
| Questions and answers on the review of bisphosphonates and atypical stress fractures download document… |
| Questions and answers on the recommendation to lift the suspension of Octagam (human normal immunoglobulin 5% and 10%) download document… |
| Questions and answers on the review of Tygacil (tigecycline) download document… |
| Questions and answers on the supply shortage of Simponi pre-filled pens download document… |
| Questions and answers on the review of Zerit (stavudine) download document… |
| Questions and answers on the possible risk of liver injury with Multaq (dronedarone) download document… |
National Agency for Medicines and Medical Devices of Romania
