欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/0302/002
药品名称
Valsarthon
活性成分
valsartan 80.0 mg
剂型
Film-coated tablet
上市许可持有人
Synthon, B.V Microweg, 22 Nijmegen The Netherlands
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Poland (PL)
Romania (RO)
Gervaton 80 mg comprimate filmate
许可日期
2010/06/23
最近更新日期
2016/05/13
药物ATC编码
C09CA03 valsartan
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial 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 SPC
|
PT302-304_Valsartan_Synthon_SPC_final
Date of last change:2011/01/28
Final Labelling
|
PT302-304_Valsartan_Synthon_labelling_final
Date of last change:2011/01/28
Final PL
|
PT302-304_Valsartan_Synthon_PL_final
Date of last change:2011/01/28
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase