欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/0210/003
药品名称
Gabapentin Gabamox
活性成分
gabapentin 400.0 mg
剂型
Capsule, hard
上市许可持有人
Pentafarma - Sociedade Técnico-Medicinal, S.A.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Hungary (HU)
Grimodin 400 mg kemény kapszula
Bulgaria (BG)
Grimodin
Czechia (CZ)
Grimodin 400 mg
Romania (RO)
Grimodin 400 mg capsule
Slovakia (SK)
Grimodin 400 mg tvrdé kapsuly
许可日期
2009/02/13
最近更新日期
2024/05/10
药物ATC编码
N03AX12 gabapentin
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final SPC
|
gabapentin_caps_common_smpc_clean
Date of last change:2024/09/24
Final PL
|
gabapentin_caps_common_pl_clean
Date of last change:2024/09/24
Final Labelling
|
lbl400_common_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase