欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
IS/H/0388/004
药品名称
Gerolimid
活性成分
lenalidomide 10.0 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. 10 mg Hartkapseln
Poland (PL)
Gerolimid
Lithuania (LT)
Lenalidomide G.L. 10 mg kietosios kapsulės
Hungary (HU)
Lenalidomide G.L. 10 mg kemény kapszula
Czechia (CZ)
Gerolimid
许可日期
2020/07/17
最近更新日期
2025/01/07
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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