欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
FI/H/0906/001
药品名称
Balcoga 20 mg
活性成分
SILDENAFIL CITRATE citrate 20.0 mg
剂型
Film-coated tablet
上市许可持有人
Sandoz A/S Edvard Thomsens Vej 14 DK-2300 Kobenhavn S DENMARK
参考成员国 - 产品名称
Finland (FI)
互认成员国 - 产品名称
Germany (DE)
Sildenafil - 1 A Pharma 20 mg Filmtabletten
Belgium (BE)
Balcoga 20 mg filmomhulde tabletten
Netherlands (NL)
Ireland (IE)
Austria (AT)
Spain (ES)
Italy (IT)
Bulgaria (BG)
Balcoga
Czechia (CZ)
BALCOGA 20 MG
Slovakia (SK)
Balcoga 20 mg filmom obalené tablety
Slovenia (SI)
许可日期
2016/09/28
最近更新日期
2024/11/27
药物ATC编码
G04BE03 sildenafil
申请类型
TypeLevel1:
Known Active Substance
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
|
common_pl
Date of last change:2024/09/06
Final SPC
|
common_spc
Date of last change:2024/09/06
PubAR
|
FI_H_906_7_01_DC_Public AR_final
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase