欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0481/001
药品名称
Gabapentin "Actavis"
活性成分
Gabapentin 100.0 mg
剂型
Capsule, hard
上市许可持有人
Actavis Group PTC ehf. Dalshraun 1 220 Hafnarfjördur Island
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Sweden (SE)
许可日期
2004/06/17
最近更新日期
2025/02/05
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
|
gabapentin_dk_h_0481_001_003_pil_08_12_23
Date of last change:2024/10/24
Final SPC
|
gabapentin_dk_h_0481_001_003_smpc_08_12_23
Date of last change:2024/10/24
Final Labelling
|
Gabapentin_DK_H_0481_001_003_OuP_transfer
Date of last change:2024/09/06
Final Product Information
|
PI_Gabapentin_DK_H_0481_01_03_V051_v6_1_20170711 Clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase