欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0398/003
药品名称
Gabaratio
活性成分
gabapentin 400.0 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
2024/07/24
药物ATC编码
N03AX12 gabapentin
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Generic Article 4.8(a)(iii), first paragraph
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
gabapentin_dk_h_0398_001_003_pil_08_12_23
Date of last change:2024/07/24
Final SPC
|
gabapentin_dk_h_0398_001_003_smpc_08_12_23
Date of last change:2024/07/24
Final Labelling
|
Gabapentin-DK_H_0398_001-003-ImP (bottle)-15.10.19
Date of last change:2019/11/25
Final Labelling
|
Gabapentin-DK_H_0398_001-003-OuP-15.10.19
Date of last change:2019/11/25
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase