欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
PT/H/2019/001
药品名称
Tadalafil Biofarmoz
活性成分
tadalafil 2.5 mg
剂型
Film-coated tablet
上市许可持有人
Biofarmoz - Sociedade Técnico Medicinal, Unip. Lda.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Spain (ES)
Italy (IT)
许可日期
2018/09/12
最近更新日期
2024/01/26
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
Final Product Information
|
immediate_packaging_tadalafil_EN
Date of last change:2024/09/06
Final Product Information
|
outer_packaging_tadalafil_EN_clean
Date of last change:2024/09/06
Final Product Information
|
PI_Tadalafil_10mg_EN_clean
Date of last change:2024/09/06
Final Product Information
|
PI_Tadalafil_2_5mg_EN_clean
Date of last change:2024/09/06
Final PL
|
PI_Tadalafil_2_5mg_EN_proposed_clean
Date of last change:2024/09/06
Final Product Information
|
PI_Tadalafil_20mg_EN_clean
Date of last change:2024/09/06
Final Product Information
|
PI_Tadalafil_5mg_EN_clean
Date of last change:2024/09/06
PubAR
|
PT_2019_PAR_final
Date of last change:2024/09/06
Final Product Information
|
SmPC_Tadalafil_10_20mg_EN_clean
Date of last change:2024/09/06
Final Product Information
|
SmPC_Tadalafil_2_5mg_EN_clean
Date of last change:2024/09/06
Final SPC
|
SmPC_Tadalafil_2_5mg_EN_proposed_clean
Date of last change:2024/09/06
Final Product Information
|
SmPC_Tadalafil_5mg_EN_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase