欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/1359/001
药品名称
Cromiva
活性成分
Miglustat 100.0 mg
剂型
Capsule, hard
上市许可持有人
Glenmark Generics (Europe) Limited United Kingdom
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Germany (DE)
Miglustat Glenmark 100 mg Hartkapseln
United Kingdom (Northern Ireland) (XI)
Czech Republic (CZ)
CROMIVA 100 MG
许可日期
2014/09/23
最近更新日期
2015/10/01
药物ATC编码
A16AX06 miglustat
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Multiple (Copy) Application
TypeLevel3:
Generic
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
SE_H_1359_001_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_1359_001_Final SPC
Date of last change:2024/09/06
PubAR
|
SE_H_1359_001_PAR
Date of last change:2024/09/06
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European Union HMA Authorisation of Medicines DataBase