欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/1472/003
药品名称
Sildenafil Hexal
活性成分
sildenafil acetate 75.0 mg
剂型
Tablet
上市许可持有人
Hexal AG
参考成员国 - 产品名称
Netherlands (NL)
SildeHEXAL 25/50/75/100 mg, tabletten
互认成员国 - 产品名称
许可日期
2009/09/10
最近更新日期
2020/11/09
药物ATC编码
G04BE03 sildenafil
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Other Generic application Art 10.3 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 _ 10_787_clean
Date of last change:2024/09/06
Final SPC
|
1_3_1 spc_label_pl _ common_spc _ 10_228_clean
Date of last change:2024/09/06
Final Labelling
|
common_outer
Date of last change:2024/09/06
Final Labelling
|
common_spc okt 2019
Date of last change:2024/09/06
市场状态
Withdrawn(注:已撤市)
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European Union HMA Authorisation of Medicines DataBase