欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2386/004
药品名称
Aktiprol
活性成分
Amisulpride 400.0 mg
剂型
Tablet
上市许可持有人
Medichemie Ltd. 1-10 Constantinoupoleos Street 3011 Limassol Cyprus
参考成员国 - 产品名称
Denmark (DK)
Aktiprol
互认成员国 - 产品名称
Greece (GR)
AKTIPROL
Latvia (LV)
Aktiprol 400 mg tabletes
Lithuania (LT)
AKTIPROL 400 mg tabletės
Bulgaria (BG)
Medosulpride
Cyprus (CY)
AKTRIPROL TABS
Romania (RO)
AKTIPROL 400 mg comprimate
Slovakia (SK)
AKTIPROL 400 mg tablety
Malta (MT)
Croatia (HR)
Aktiprol 400 mg tablete
许可日期
2015/04/20
最近更新日期
2025/01/08
药物ATC编码
N05AL05 amisulpride
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
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 Labelling
|
2386 common_labelling_v1_2_clean
Date of last change:2024/09/06
Final PL
|
common_pil_march2015_v1_3_clean
Date of last change:2024/09/06
Final SPC
|
common_spc_feb2015_v1_2_clean
Date of last change:2024/09/06
PubAR
|
Final PAR Aktiprol DKH2386_001_004_DC
Date of last change:2024/09/06
PubAR Summary
|
Final sPAR Aktiprol DKH2386_001_004_DC
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase