欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0398/001
药品名称
Gabaratio
活性成分
gabapentin 100.0 mg
剂型
Capsule, hard
上市许可持有人
Ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Germany (DE)
United Kingdom (Northern Ireland) (XI)
Portugal (PT)
Italy (IT)
许可日期
2003/02/04
最近更新日期
2023/10/02
药物ATC编码
N03AX12 gabapentin
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Generic Article 4.8(a)(iii), first paragraph
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
Common_PIL_DK_H_0398_001_003_clean
Date of last change:2023/06/06
Final SPC
|
Common_SmPC_DK_H_0398_001_003_clean
Date of last change:2023/06/06
Final Labelling
|
Gabapentin 100, 300, 400 mg capsules, hard-DK_H_395-398-403_001-003-OuP(blister+bottle)-10.07.17_Clean
Date of last change:2017/11/10
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase