欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DK/H/3433/001
药品名称
Gabapentin Teva
活性成分
Gabapentin 100.0 mg
剂型
Capsule, hard
上市许可持有人
Teva B.V. Swensweg 5 2031GA Haarlem Netherlands
参考成员国 - 产品名称
Denmark (DK)
Gabapentin Teva
互认成员国 - 产品名称
Netherlands (NL)
Slovakia (SK)
Iceland (IS)
Ireland (IE)
Austria (AT)
France (FR)
Spain (ES)
Portugal (PT)
Italy (IT)
Sweden (SE)
Poland (PL)
Germany (DE)
Gabapentin Teva 100 mg Hartkapseln
Czechia (CZ)
Gabapentin Teva B.V.
Belgium (BE)
Romania (RO)
许可日期
2024/12/05
最近更新日期
2025/05/16
药物ATC编码
N02BF01 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
PubAR Summary
|
PAR_Summary_Gabapentin Teva_DK_H_3433_001_003_DC
Date of last change:2025/01/21
PubAR
|
PAR_Scientific discussion_Gabapentin Teva_DK_H_3433_001_003_DC
Date of last change:2025/01/21
Final Product Information
|
gabapentin_dk_h_3433_3435_001_003_dc_oup_imp_bottles_fullre
Date of last change:2024/12/05
Final Labelling
|
gabapentin_dk_h_3433_3435_001_003_dc_OuP_ImP_blister_fullre
Date of last change:2024/12/05
Final PL
|
gabapentin_dkh3433_3435001_003dc_PIL_22_11_24
Date of last change:2024/12/05
Final SPC
|
gabapentin_dkh3433_3435001_003dc_SmPC_22_11_24
Date of last change:2024/12/05
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase