欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0505/001
药品名称
Gabapenstad
活性成分
gabapentin 100.0 mg
剂型
Capsule, hard
上市许可持有人
Stada Arzneimittel AG Stadastrasse 2-18 61118 Bad Vilbel Germany
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Iceland (IS)
Germany (DE)
Gabapentin AL 100 mg Hartkapseln
许可日期
2004/06/17
最近更新日期
2024/04/26
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 Labelling
|
1_3_1_LAB_outer_carton_common_en_DK_H_0505_001_003_cl_1_
Date of last change:2024/09/06
Final PL
|
1_3_1_PIL_common_en_DK_H_0505_001_003_cl
Date of last change:2024/09/06
Final SPC
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1_3_1_SPC_common_en_DK_H_0505_001_003_cl
Date of last change:2024/09/06
Final Product Information
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PIL_common_en_DK_H_0505_001_003_cl
Date of last change:2024/09/06
Final Product Information
|
SPC_common_en_DK_H_0505_001_003_cl
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase