欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/1470/001
药品名称
Sildenafil Sandoz
活性成分
Sildenafil citrate 25.0 mg
剂型
Tablet
上市许可持有人
Sandoz GmbH
参考成员国 - 产品名称
Netherlands (NL)
Sildenafil Sandoz
互认成员国 - 产品名称
Denmark (DK)
Belgium (BE)
United Kingdom (Northern Ireland) (XI)
France (FR)
Spain (ES)
Portugal (PT)
Italy (IT)
Sweden (SE)
许可日期
2009/09/10
最近更新日期
2024/10/24
药物ATC编码
G04BE03 sildenafil
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 PL
|
1_3_1 spc_label_pl _ common_pl _ 11_373
Date of last change:2024/09/06
Final SPC
|
1_3_1 spc_label_pl _ common_spc _ 10_821
Date of last change:2024/09/06
Final Labelling
|
common_outer
Date of last change:2024/09/06
Final Labelling
|
common_spc
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase