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
Procysbi Human mercaptamine mercaptamine bitartrate EMEA/H/C/002465 Chiesi Farmaceutici S.p.A 2013/09/05 Authorised
Cholib Human fenofibrate;simvastatin fenofibrate;simvastatin EMEA/H/C/002559 Viatris Healthcare Limited 2013/08/26 Authorised
Aubagio Human teriflunomide teriflunomide EMEA/H/C/002514 Sanofi Winthrop Industrie 2013/08/26 Authorised
Tafinlar Human dabrafenib dabrafenib mesilate EMEA/H/C/002604 Novartis Europharm Limited 2013/08/26 Authorised
Stivarga Human regorafenib regorafenib EMEA/H/C/002573 Bayer Pharma AG 2013/08/26 Authorised
Nexium Control Human esomeprazole esomeprazole EMEA/H/C/002618 Haleon Ireland Dungarvan Limited 2013/08/26 Authorised
Voncento Human human coagulation factor VIII / human von willebrand factor human coagulation factor VIII;human von willebrand factor EMEA/H/C/002493 CSL Behring GmbH 2013/08/12 Authorised
Imnovid (previously Pomalidomide Celgene) Human pomalidomide Pomalidomide EMEA/H/C/002682 Bristol-Myers Squibb Pharma EEIG 2013/08/05 Authorised
Somatropin Biopartners Human somatropin somatropin EMEA/H/C/002196 BioPartners GmbH 2013/08/05 Lapsed
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 EMEA/V/C/002292 Boehringer Ingelheim Vetmedica GmbH 2013/07/15 Withdrawn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

数据库说明:

©2006-2025 DrugFuture->European Medicines Agency Authorisation of Medicines DataBase