欧盟EMA药品数据库-欧盟集中审批药品
（European Medicines Agency Authorisation of Medicines DataBase）
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数据记录共 2655 条，共 133 页，当前第 56 页
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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
Imvanex Human smallpox and monkeypox vaccine (Live Modified Vaccinia Virus Ankara) modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus EMEA/H/C/002596 Bavarian Nordic A/S 2013/07/31 Authorised
Lojuxta Human lomitapide Lomitapide EMEA/H/C/002578 Chiesi Farmaceutici SpA 2013/07/31 Authorised
Atosiban SUN Human atosiban atosiban (as acetate) EMEA/H/C/002329 Sun Pharmaceutical Industries Europe B.V. 2013/07/31 Authorised
Pheburane Human sodium phenylbutyrate sodium phenylbutyrate EMEA/H/C/002500 Eurocept International B. V. 2013/07/30 Authorised
Lonquex Human lipegfilgrastim lipegfilgrastim EMEA/H/C/002556 Teva B.V. 2013/07/25 Authorised
Aftovaxpur DOE Veterinary inactivated vaccine against foot-and-mouth disease Maximum three of the following purified, inactivated foot-and-mouth disease virus strains: O1 Manisa ≥ 6 PD50*; O1 BFS ≥ 6 PD50*; O Taiwan 3/97 ≥ 6 PD50*; A22 Iraq ≥ 6 PD50*; A24 Cruzeiro ≥ 6 PD50*; A Turkey 14/98 ≥ 6 PD50*; Asia 1 Shamir ≥ 6 PD50*; SAT2 Saudi Arabia ≥ 6 PD50*; * PD50 – 50% protective dose in cattle as described in Ph. Eur. monograph 0063. EMEA/V/C/002292 Boehringer Ingelheim Vetmedica GmbH 2013/07/15 Withdrawn
Erivedge Human vismodegib vismodegib EMEA/H/C/002602 Roche Registration GmbH 2013/07/12 Authorised
Iclusig Human ponatinib ponatinib EMEA/H/C/002695 Incyte Biosciences Distribution B.V. 2013/07/01 Authorised
Imatinib Accord Human imatinib imatinib EMEA/H/C/002681 Accord Healthcare S.L.U. 2013/06/30 Authorised
Maci Human matrix-applied characterised autologous cultured chondrocytes autologous cultured chondrocytes EMEA/H/C/002522 Vericel Denmark ApS 2013/06/27 Expired
Stayveer Human bosentan monohydrate bosentan (as monohydrate) EMEA/H/C/002644 Janssen-Cilag International NV 2013/06/24 Authorised
Nuedexta Human dextromethorphan hydrobromide;quinidine sulfate dextromethorphan;quinidine EMEA/H/C/002560 Jenson Pharmaceutical Services Limited 2013/06/24 Withdrawn
Spedra Human avanafil avanafil EMEA/H/C/002581 Menarini International Operations Luxembourg S.A. 2013/06/21 Authorised
Xtandi Human enzalutamide enzalutamide EMEA/H/C/002639 Astellas Pharma Europe B.V. 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
HyQvia Human human normal immunoglobulin human normal immunoglobulin EMEA/H/C/002491 Baxalta Innovations GmbH 2013/05/16 Authorised
Voriconazole Accord Human voriconazole voriconazole EMEA/H/C/002669 Accord Healthcare S.L.U. 2013/05/16 Authorised
Marixino (previously Maruxa) Human memantine memantine hydrochloride EMEA/H/C/002658 KRKA, d.d. 2013/04/28 Authorised

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