欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/2512/007
药品名称
Lenalidomida Generis
活性成分
lenalidomide 25.0 mg
剂型
Capsule, hard
上市许可持有人
Generis Farmacêutica, S.A.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Czechia (CZ)
Lenalidomid Aurovitas
Romania (RO)
Lenalidomidă Aurobindo 25 mg capsule
Germany (DE)
Belgium (BE)
Lenalidomide Eugia 25 mg harde capsules
Netherlands (NL)
France (FR)
Spain (ES)
Poland (PL)
Lenalidomide Aurovitas
许可日期
2021/09/17
最近更新日期
2024/08/30
药物ATC编码
L04AX04 lenalidomide
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
common_combined
Date of last change:2024/09/06
Final SPC
|
common_spc
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase