欧盟EMA药品数据库-欧盟集中审批药品
(European Medicines Agency Authorisation of Medicines DataBase)
商品名称 适用类别 通用名称 活性成分 产品号 上市许可开发者/申请人/持有人 上市许可日期 许可状态
Nuedexta Human dextromethorphan hydrobromide;quinidine sulfate dextromethorphan;quinidine EMEA/H/C/002560 Jenson Pharmaceutical Services Limited 2013/06/24 Withdrawn
Xtandi Human enzalutamide enzalutamide EMEA/H/C/002639 Astellas Pharma Europe B.V. 2013/06/21 Authorised
Spedra Human avanafil avanafil EMEA/H/C/002581 Menarini International Operations Luxembourg S.A. 2013/06/21 Authorised
Capecitabine SUN Human capecitabine capecitabine EMEA/H/C/002050 Sun Pharmaceutical Industries Europe B.V. 2013/06/21 Withdrawn
Memantine ratiopharm Human memantine memantine hydrochloride EMEA/H/C/002671 Ratiopharm GmbH 2013/06/12 Authorised
Stribild Human elvitegravir;cobicistat;emtricitabine;tenofovir disoproxil elvitegravir;cobicistat;emtricitabine;tenofovir disoproxil fumarate EMEA/H/C/002574 Gilead Sciences Ireland UC 2013/05/24 Authorised
Voriconazole Accord Human voriconazole voriconazole EMEA/H/C/002669 Accord Healthcare S.L.U. 2013/05/16 Authorised
HyQvia Human human normal immunoglobulin human normal immunoglobulin EMEA/H/C/002491 Baxalta Innovations GmbH 2013/05/16 Authorised
Marixino (previously Maruxa) Human memantine memantine hydrochloride EMEA/H/C/002658 KRKA, d.d. 2013/04/28 Authorised
Nemdatine Human memantine memantine EMEA/H/C/002680 Actavis Group PTC ehf 2013/04/22 Authorised
Memantine Mylan Human memantine memantine hydrochloride EMEA/H/C/002660 Mylan Pharmaceuticals Limited 2013/04/21 Authorised
Memantine LEK Human memantine memantine hydrochloride EMEA/H/C/002630 Pharmathen S.A. 2013/04/21 Withdrawn
Hexyon Human diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed) filamentous haemagglutinin;Haemophilus influenzae type B polysaccharide (polyribosylribitol phosphate);hepatitis B surface antigen;pertussis toxoid;poliovirus (inactivated) type 1 (Mahoney strain) produced on Vero cells;poliovirus (inactivated) type 2 (MEF-1 strain) produced on Vero cells;poliovirus (inactivated) type 3 (Saukett strain) produced on Vero cells;tetanus protein;tetanus toxoid adsorbed on aluminium hydroxide, hydrated;Diphtheria toxoid EMEA/H/C/002796 Sanofi Winthrop Industrie 2013/04/17 Authorised
Hexacima Human diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed) hepatitis B surface antigen;Diphtheria toxoid;Bordetella pertussis antigens Pertussis Toxoid Filamentous Haemagglutinin;poliovirus (inactivated) type 1 (Mahoney) type 2 (MEF-1) type 3 (Saukett);Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate) conjugated to Tetanus protein;tetanus toxoid EMEA/H/C/002702 Sanofi Winthrop Industrie 2013/04/17 Authorised
Imatinib Actavis Human imatinib imatinib EMEA/H/C/002594 Actavis Group PTC ehf 2013/04/17 Withdrawn
Ecoporc Shiga Veterinary genetically modified Shiga-toxin-2e antigen genetically modified recombinant Shiga-toxin-2e antigen EMEA/V/C/002588 2013/04/10 Authorised
Bosulif Human bosutinib bosutinib (as monohydrate) EMEA/H/C/002373 Pfizer Europe MA EEIG 2013/03/27 Authorised
Tolucombi Human telmisartan;hydrochlorothiazide telmisartan;hydrochlorothiazide EMEA/H/C/002549 Krka, d.d., Novo mesto 2013/03/13 Authorised
Jetrea Human ocriplasmin ocriplasmin EMEA/H/C/002381 Inceptua AB 2013/03/13 Withdrawn
Actelsar HCT Human telmisartan;hydrochlorothiazide telmisartan;hydrochlorothiazide EMEA/H/C/002676 Actavis Group PTC ehf 2013/03/13 Authorised

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