欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/1599/002
药品名称
Tadalafil Genepharm
活性成分
tadalafil 5.0 mg
剂型
Film-coated tablet
上市许可持有人
Genepharm, S.A
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Greece (GR)
TADALAFIL/GENEPHARM
Cyprus (CY)
许可日期
2016/10/25
最近更新日期
2024/09/01
药物ATC编码
G04BE08 tadalafil
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
PubAR
|
1599_Genement_PAR___MAR2019_IRS_V02_Revisto req
Date of last change:2024/09/06
Final Labelling
|
common_outer_10mg_clean
Date of last change:2024/09/06
Final Labelling
|
common_outer_2_5mg_clean
Date of last change:2024/09/06
Final Labelling
|
common_outer_20mg_clean
Date of last change:2024/09/06
Final Labelling
|
common_outer_5mg_clean
Date of last change:2024/09/06
Final PL
|
common_pl_10mg_clean
Date of last change:2024/09/06
Final PL
|
common_pl_2_5mg_clean
Date of last change:2024/09/06
Final PL
|
common_pl_20mg_clean
Date of last change:2024/09/06
Final PL
|
common_pl_5mg_clean
Date of last change:2024/09/06
Final SPC
|
common_spc_10mg_clean
Date of last change:2024/09/06
Final SPC
|
common_spc_2_5mg_clean
Date of last change:2024/09/06
Final SPC
|
common_spc_20mg_clean
Date of last change:2024/09/06
Final SPC
|
common_spc_5mg_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase