欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
IS/H/0388/001
药品名称
Gerolimid
活性成分
lenalidomide 2.5 mg
剂型
Capsule, hard
上市许可持有人
G.L. Pharma GmbH Schlossplatz 1, Lannach 8502 Austria
参考成员国 - 产品名称
Iceland (IS)
Gerolimid
互认成员国 - 产品名称
Austria (AT)
Lenalidomid G.L. 2,5 mg Hartkapseln
许可日期
2020/07/17
最近更新日期
2024/04/09
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
|
IS_H_0388_001_007_IB_016_PIL_clean_9_4_2024
Date of last change:2024/09/06
Final SPC
|
IS_H_0388_001_007_IB_016_SmPC_clean_9_4_2024
Date of last change:2024/09/06
Final Labelling
|
IS_H_0388_IA_015_G_LAB_Lenalidomide_G_L__14_6_2023
Date of last change:2024/09/06
PubAR
|
IS_H_0388_Lenalidomide G_L__001_007_PAR
Date of last change:2024/09/06
PubAR Summary
|
IS_H_0388_Lenalidomide G_L__001_007_PARsummary
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase