欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/1470/004
药品名称
Sildenafil Sandoz
活性成分
Sildenafil citrate 100.0 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)
Austria (AT)
France (FR)
Spain (ES)
Portugal (PT)
Italy (IT)
Greece (GR)
Sweden (SE)
Finland (FI)
Poland (PL)
Latvia (LV)
Lithuania (LT)
Estonia (EE)
Hungary (HU)
Czechia (CZ)
Slovakia (SK)
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