欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
CZ/H/0107/003
药品名称
Simgal 40 mg
活性成分
simvastatin 40.0 mg
剂型
Film-coated tablet
上市许可持有人
TEVA Czech Industries s.r.o., Opava-Komárov Czech Republic
参考成员国 - 产品名称
Czechia (CZ)
互认成员国 - 产品名称
许可日期
2005/09/12
最近更新日期
2017/11/24
药物ATC编码
C10AA01 simvastatin
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Generic [Article 10.1.(a)(iii), first paragraph]
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
CZ_PIL_Simgal clean
Date of last change:2024/09/06
Final Labelling
|
EN_Labelling_Simgal_RMS comments New D20_cl
Date of last change:2024/09/06
Final SPC
|
SIMGAL_SPC_final
Date of last change:2024/09/06
市场状态
Withdrawn(注:已撤市)
©2006-2024
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European Union HMA Authorisation of Medicines DataBase