欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
PL/H/0621/001
药品名称
Erlis
活性成分
tadalafil 2.5 mg
剂型
Film-coated tablet
上市许可持有人
Zakłady Farmaceutyczne POLPHARMA S.A. Ul. Pelplińska 19 83-200 Starogard Gdanski
参考成员国 - 产品名称
Poland (PL)
Erlis
互认成员国 - 产品名称
许可日期
2019/01/28
最近更新日期
2024/01/12
药物ATC编码
G04BE08 tadalafil
申请类型
TypeLevel1：
[not specified]
TypeLevel2：
[not specified]
TypeLevel3：
[not specified]
TypeLevel4：
[not specified]
TypeLevel5：
[not specified]
附件文件下载
Final Product Information
|
PIL_Tadalafil_10mg_2019_12EN_track_OLD
Date of last change:2024/09/06
Final Product Information
|
PIL_Tadalafil_2_5mg_2019_12EN_track_OLD
Date of last change:2024/09/06
Final Product Information
|
PIL_Tadalafil_20mg_2019_12EN_track_OLD
Date of last change:2024/09/06
Final Product Information
|
PIL_Tadalafil_5mg_2019_12EN_track_OLD
Date of last change:2024/09/06
Final Product Information
|
SmPC_Tadalafil_10mg_2019_12EN_track_PhV_OLD_Annex_1
Date of last change:2024/09/06
Final Product Information
|
SmPC_Tadalafil_2_5mg_2019_12EN_track_PhV_OLD_Annex_1
Date of last change:2024/09/06
Final Product Information
|
SmPC_Tadalafil_20mg_2019_12EN_track_PhV_OLD_Annex_1
Date of last change:2024/09/06
Final Product Information
|
SmPC_Tadalafil_5mg_2019_12EN_track_PhV_OLD_Annex_1
Date of last change:2024/09/06
Final Labelling
|
final_LAB_AT_H_1323_001_R_001_2_5mg
Date of last change:2024/09/06
Final PL
|
final_PL_AT_H_1323_001_R_001_2_5mg
Date of last change:2024/09/06
Final SPC
|
revised_final_SmPC_AT_H_1323_001_R_001_2_5mg
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase