欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0397/003
药品名称
Gabatifin
活性成分
gabapentin 400.0 mg
剂型
Capsule, hard
上市许可持有人
Generics UK Ltd. Station Close, Potters Bar Hertfordshire, EN6 1 TL UK
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Iceland (IS)
Portugal (PT)
许可日期
2003/02/04
最近更新日期
2023/11/10
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 Product Information
|
Gabatifin_common_combined_Gabapentin_dk0397_v088_clean
Date of last change:2023/10/19
Final PL
|
common-combined-dk0397-v079-clean[1]
Date of last change:2021/10/05
Final Labelling
|
common-interpack-1-cl
Date of last change:2018/12/07
Final SPC
|
common-spc-dk0397-100mg-clean-v70
Date of last change:2017/10/11
Final SPC
|
common-spc-dk0397-300mg-clean-v70
Date of last change:2017/10/11
Final SPC
|
common-spc-dk0397-400mg-clean-v70
Date of last change:2017/10/11
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase