欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0397/002
药品名称
Gabatifin
活性成分
Gabapentin 300.0 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
Portugal (PT)
Iceland (IS)
许可日期
2003/02/04
最近更新日期
2025/01/02
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
|
common_combined_dk0397_v079_clean_1_
Date of last change:2024/09/06
Final Labelling
|
common_interpack_1_cl
Date of last change:2024/09/06
Final SPC
|
common_spc_dk0397_100mg_clean_v70
Date of last change:2024/09/06
Final SPC
|
common_spc_dk0397_300mg_clean_v70
Date of last change:2024/09/06
Final SPC
|
common_spc_dk0397_400mg_clean_v70
Date of last change:2024/09/06
Final Product Information
|
Gabatifin_common_combined_Gabapentin_dk0397_v088_clean
Date of last change:2024/09/06
市场状态
Positive
©2006-2025
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European Union HMA Authorisation of Medicines DataBase