欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/1751/001
药品名称
Loprilin 10mg
活性成分
omeprazole 10.0 mg
剂型
Gastro-resistant capsule*
上市许可持有人
Chemo Iberica SA Gran Via Carlos 111 Barcelona Spain
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
United Kingdom (Northern Ireland) (XI)
Sweden (SE)
许可日期
2010/06/25
最近更新日期
2024/04/12
药物ATC编码
A02BC01 omeprazole
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Multiple (Copy) 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
|
Common PIL
Date of last change:2024/09/06
Final SPC
|
Common SmPC
Date of last change:2024/09/06
PubAR
|
PAR_1751_MR_omeprazol_10 mar 2011
Date of last change:2024/09/06
Final Product Information
|
PL_OME_CC_NL_H_1751_IB_016_G_D30_new_seq_tracked
Date of last change:2024/09/06
Final Product Information
|
SPC_OME_CC_NL_H_1751_IB_016_G_D30_tracked
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase