欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0381/004
药品名称
Vasilip
活性成分
simvastatin 40.0 mg
剂型
Film-coated tablet
上市许可持有人
KRKA d.d. Novo mesto Smarjeska cesta 6 8501 Novo mesto Slovenia
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Austria (AT)
Simvastatin Alternova 40 mg - Filmtabletten
Italy (IT)
许可日期
2002/12/19
最近更新日期
2023/11/30
药物ATC编码
C10AA01 simvastatin
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Generic Article 4.8(a)(iii), first paragraph
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Labelling
|
0381 common_other cl
Date of last change:2024/09/06
Final PL
|
0381 common_pl_2 cl
Date of last change:2024/09/06
Final SPC
|
0381 common_spc cl
Date of last change:2024/09/06
Final Product Information
|
common_combined_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase