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 上市许可持有人/公司名称 上市批准日期 授权状态
Qsiva Human phentermine, topiramate phentermine, topiramate EMEA/H/C/002350 Vivus BV Refused
Labazenit Human budesonide, salmeterol Budesonide, salmeterol EMEA/H/C/002201 Laboratoires SMB S.A.   Refused
Istodax Human romidepsin romidepsin EMEA/H/C/002122 Celgene Europe Ltd. Refused
Acrescent Human memantine hydrochloride, donepezil hydrochloride memantine hydrochloride, donepezil hydrochloride EMEA/H/C/002424 H. Lundbeck A/S Refused
Balaxur Human memantine hydrochloride, donepezil hydrochloride memantine hydrochloride, donepezil hydrochloride EMEA/H/C/002708 Merz Pharmaceuticals GmbH Refused
Nouryant Human istradefylline Istradefylline EMEA/H/C/005308 Kyowa Kirin Holdings B.V. Refused
Longrange Veterinary eprinomectin eprinomectin EMEA/V/C/004291 Merial Refused
Eladynos Human abaloparatide abaloparatide EMEA/H/C/004157 Radius Health Ireland Ltd Refused
Elelyso Human taliglucerase alfa Taliglucerase alfa EMEA/H/C/002250 Pfizer Ltd.    Refused
Folotyn Human pralatrexate Pralatrexate EMEA/H/C/002096 Allos Therapeutics Ltd Refused
Gamifant Human emapalumab Emapalumab EMEA/H/C/004386 Swedish Orphan Biovitrum AB (publ) Refused
Lextemy Human bevacizumab bevacizumab EMEA/H/C/005611 Mylan IRE Healthcare Limited Withdrawn
Exondys Human eteplirsen eteplirsen EMEA/H/C/004355 AVI Biopharma International Ltd Refused
Dexxience Human betrixaban betrixaban maleate EMEA/H/C/004309 Portola Pharma UK Limited Refused
Alsitek Human masitinib Masitinib mesilate EMEA/H/C/004398 AB Science Refused
Sumatriptan Galpharm Human sumatriptan sumatriptan succinate EMEA/H/C/002140 Galpharm Healthcare Ltd. Refused
Xeljanz Human tofacitinib Tofacitinib EMEA/H/C/002542 Pfizer Limited Refused
Masipro Human masitinib Masitinib mesilate EMEA/H/C/004159 AB Science Refused
Fanaptum Human iloperidone iloperidone EMEA/H/C/004149 Vanda Pharmaceuticals Ltd Refused
Zoonotic Influenza Vaccine Seqirus Human zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted), influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/turkey/Turkey/1/05 (H5N1)-like strain (NIBRG-23) EMEA/H/C/006375 Seqirus S.r.l.  Authorised

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