欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
FR/H/0003/014
药品名称
EPREX
活性成分
epoetin alfa 40000.0 IU/ml
剂型
Solution for injection
上市许可持有人
JANSSEN CILAG
参考成员国 - 产品名称
France (FR)
互认成员国 - 产品名称
Germany (DE)
Erypo FS 20.000 I.E/ 0,5 ml
Denmark (DK)
Eprex
Netherlands (NL)
Eprex 40.000 IE/ml
Luxembourg (LU)
United Kingdom (Northern Ireland) (XI)
Austria (AT)
ERYPO 40.000 I.E./ml - Fertigspritzen
Spain (ES)
Italy (IT)
Greece (GR)
Portugal (PT)
Belgium (BE)
许可日期
2006/04/11
最近更新日期
2024/07/03
药物ATC编码
B03XA01 erythropoietin
申请类型
TypeLevel1:
Line Extension
TypeLevel2:
Initial Application
TypeLevel3:
Full Dossier Art 8.3(i) Dir 2001/83/EC
TypeLevel4:
Biological: Other
TypeLevel5:
Prescription Only
附件文件下载
Final SPC
|
common-combined-clean
Date of last change:2021/06/25
Final SPC
|
common-combined-annotated
Date of last change:2021/06/25
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase