欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/0211/002
药品名称
Gabapentin Gabamox
活性成分
Gabapentin 800.0 mg
剂型
Film-coated tablet
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 800 mg filmtabletta
Bulgaria (BG)
Grimodin
Romania (RO)
Grimodin 800 mg comprimate filmate
Slovakia (SK)
Grimodin 800 mg tablety
许可日期
2009/02/13
最近更新日期
2025/01/03
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 PL
|
gabapentin_fct_pl_common_harm_tracked
Date of last change:2025/01/03
Final SPC
|
gabapentin_fct_spc_common_harm_tracked
Date of last change:2025/01/03
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase