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
2024/11/06
药物ATC编码
C10A LIPID MODIFYING AGENTS, PLAIN
C10AA03 pravastatin
C CARDIOVASCULAR SYSTEM
C10AA HMG CoA reductase inhibitors
C10 LIPID MODIFYING AGENTS
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 Labelling
|
1_3_1 spc_label_pl _ common_outer _clean 4_333
Date of last change:2024/09/06
Final Product Information
|
1_3_1 spc_label_pl _ common_pl _ 11_147_clean
Date of last change:2024/09/06
Final Product Information
|
1_3_1 spc_label_pl _ common_spc_clean _ 9_231
Date of last change:2024/09/06
Final PL
|
common_pl_clean
Date of last change:2024/09/06
Final SPC
|
common_spc_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase