欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0603/001
药品名称
Pravastatin "Sandoz"
活性成分
pravastatin sodium salt 10.0 mg
剂型
Tablet
上市许可持有人
Sandoz A/S Edvard Thomsens Vej 14 2300København S Denmark
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Portugal (PT)
Netherlands (NL)
France (FR)
Spain (ES)
许可日期
2004/05/03
最近更新日期
2023/12/04
药物ATC编码
C10AA03 pravastatin
C10 LIPID MODIFYING AGENTS
C CARDIOVASCULAR SYSTEM
C10AA HMG CoA reductase inhibitors
C10A LIPID MODIFYING AGENTS, PLAIN
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 SPC
|
Common Pravastatin SmPC_clean
Date of last change:2023/11/23
Final PL
|
Common Pravastatin PIL_clean
Date of last change:2023/11/23
Final Labelling
|
1.3.1 spc-label-pl - common-outer -clean 4,333
Date of last change:2019/12/17
Final Product Information
|
1.3.1 spc-label-pl - common-pl - 11,147_clean
Date of last change:2019/09/20
Final Product Information
|
1.3.1 spc-label-pl - common-spc_clean - 9,231
Date of last change:2019/09/20
市场状态
Positive
©2006-2024
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase