欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0479/002
药品名称
Gabamed
活性成分
gabapentin 300.0 mg
剂型
Capsule, hard
上市许可持有人
Viatris Limited. Damastown Industrial Park Mulhuddart Dublin 15 Ireland
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
United Kingdom (Northern Ireland) (XI)
Italy (IT)
许可日期
2004/06/17
最近更新日期
2024/07/25
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 Labelling
|
0479 cl common_interpack_dk0479_p001_clean
Date of last change:2024/09/06
Final Product Information
|
common_combined_Gabapentin_dk0479_v083_clean
Date of last change:2024/09/06
Final PL
|
common_pl_dk0479_clean_v67
Date of last change:2024/09/06
Final SPC
|
common_spc_dk0479_100mg_clean_v65
Date of last change:2024/09/06
Final SPC
|
common_spc_dk0479_300mg_clean_v65
Date of last change:2024/09/06
Final SPC
|
common_spc_dk0479_400mg_clean_v65
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase