欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/1749/003
药品名称
Omeprazol krka 40mg
活性成分
Omeprazole 40.0 mg
剂型
Gastro-resistant capsule*
上市许可持有人
KRKA d.d. Novo mesto Slovenia
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Poland (PL)
Ultop
Portugal (PT)
许可日期
2010/03/15
最近更新日期
2024/11/04
药物ATC编码
A02BC01 omeprazole
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
|
PIL
Date of last change:2024/10/24
Final SPC
|
SmPC
Date of last change:2024/10/24
Final Product Information
|
common_combined_clean
Date of last change:2024/09/06
Final Product Information
|
common_combined_track
Date of last change:2024/09/06
PubAR
|
PAR_1749_MR_omeprazol_10 mar 2011
Date of last change:2024/09/06
市场状态
Positive
©2006-2025
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase