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
Skilarence Human dimethyl fumarate dimethyl fumarate EMEA/H/C/002157 Almirall, S.A. 2017/06/23 Authorised
Ucedane Human carglumic acid carglumic acid EMEA/H/C/004019 Eurocept International BV 2017/06/23 Authorised
Rixathon Human rituximab rituximab EMEA/H/C/003903 Sandoz GmbH 2017/06/15 Authorised
Riximyo Human rituximab rituximab EMEA/H/C/004729 Sandoz GmbH 2017/06/15 Authorised
Febuxostat Viatris (previously Febuxostat Mylan) Human febuxostat febuxostat EMEA/H/C/004374 Viatris Limited 2017/06/15 Authorised
Refixia Human nonacog beta pegol nonacog beta pegol EMEA/H/C/004178 Novo Nordisk A/S 2017/06/02 Authorised
Elmiron Human pentosan polysulfate sodium pentosan polysulfate sodium EMEA/H/C/004246 bene-Arzneimittel GmbH 2017/06/02 Authorised
Spinraza Human nusinersen nusinersen sodium EMEA/H/C/004312 Biogen Netherlands B.V. 2017/05/30 Authorised
Brineura Human cerliponase alfa cerliponase alfa EMEA/H/C/004065 BioMarin International Limited 2017/05/30 Authorised
Trumenba Human meningococcal group b vaccine (recombinant, adsorbed) Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily A; Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily B EMEA/H/C/004051 Pfizer Europe MA EEIG 2017/05/24 Authorised
Ingelvac PCV FLEX Veterinary porcine circovirus vaccine (inactivated) porcine circovirus type 2 ORF2 protein EMEA/V/C/004645 Boehringer Ingelheim Vetmedica GmbH 2017/05/24 Withdrawn
Ivabradine Accord Human ivabradine ivabradine hydrochloride EMEA/H/C/004241 Accord Healthcare S.L.U. 2017/05/22 Authorised
Axumin Human fluciclovine (18F) fluciclovine (18F) EMEA/H/C/004197 Blue Earth Diagnostics Ireland Ltd 2017/05/21 Authorised
Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron) Human dinutuximab beta Dinutuximab beta EMEA/H/C/003918 Recordati Netherlands B.V. 2017/05/08 Authorised
Emtricitabine/Tenofovir disoproxil Krka d.d. Human emtricitabine;tenofovir disoproxil emtricitabine;tenofovir disoproxil succinate EMEA/H/C/004686 KRKA, d.d., Novo mesto 2017/04/28 Authorised
Natpar Human parathyroid hormone parathyroid hormone EMEA/H/C/003861 Takeda Pharmaceuticals International AG Ireland Branch 2017/04/24 Authorised
Pemetrexed Pfizer (previously Pemetrexed Hospira UK Limited) Human pemetrexed pemetrexed ditromethamine EMEA/H/C/004488 Pfizer Europe MA EEIG 2017/04/24 Withdrawn
Roteas Human edoxaban edoxaban tosilate EMEA/H/C/004339 Berlin-Chemie AG 2017/04/19 Authorised
Varuby Human rolapitant rolapitant EMEA/H/C/004196 TESARO Bio Netherlands B.V. 2017/04/19 Withdrawn
Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau) Human chenodeoxycholic acid chenodeoxycholic acid EMEA/H/C/004061 Leadiant GmbH 2017/04/10 Authorised

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