欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
FI/H/0936/003
药品名称
Sildenafil Orion 100 mg
活性成分
sildenafil citrate 100.0 mg
剂型
Film-coated tablet
上市许可持有人
Orion Corporation Orionintie 1 FI-02200 Espoo Finland
参考成员国 - 产品名称
Finland (FI)
互认成员国 - 产品名称
Denmark (DK)
Sildorin
Sweden (SE)
许可日期
2017/10/01
最近更新日期
2023/09/28
药物ATC编码
G04BE03 sildenafil
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
PAR
|
FI-H-936-01-03-DC Sildorin, FI-H-943-01-DC Valinger_Public AR
Date of last change:2018/03/22
Final Labelling
|
Sildorin 25 50 100mg tabl DCP LABEL 180417
Date of last change:2017/12/19
Final PL
|
Sildorin 25 50 100mg tabl DCP PIL 180417
Date of last change:2017/12/19
Final SPC
|
Sildorin 25 50 100mg tabl DCP SPC 180417
Date of last change:2017/12/19
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase