欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
PT/H/1736/002
药品名称
Tadalafil Bluescience
活性成分
tadalafil 5.0 mg
剂型
Film-coated tablet
上市许可持有人
Bluescience Unipessoal, Lda.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Spain (ES)
Poland (PL)
Tadalafil Bluescience
许可日期
2017/12/20
最近更新日期
2024/01/02
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 Summary
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1736_Tadalfil_Bluescience_Summary_PAR_Scientific_PAR_genericos1ABR2020_VF
Date of last change:2024/09/06
Final Labelling
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common_inner_tadalafil10mg20170602
Date of last change:2024/09/06
Final Labelling
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common_inner_tadalafil20mg20170602
Date of last change:2024/09/06
Final Labelling
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common_inner_tadalafil25mg20170602
Date of last change:2024/09/06
Final Labelling
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common_inner_tadalafil5mg20170602
Date of last change:2024/09/06
Final Labelling
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common_outer_tadalafil10mg20170602
Date of last change:2024/09/06
Final Labelling
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common_outer_tadalafil20mg20170602
Date of last change:2024/09/06
Final Labelling
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common_outer_tadalafil25mg20170602
Date of last change:2024/09/06
Final Labelling
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common_outer_tadalafil5mg20170602
Date of last change:2024/09/06
Final Product Information
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common_outer_tadalafil5mg20170602_2
Date of last change:2024/09/06
Final PL
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common_pl_tadalfil10mg20170602
Date of last change:2024/09/06
Final PL
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common_pl_tadalfil20mg20170602
Date of last change:2024/09/06
Final PL
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common_pl_tadalfil25mg20170602
Date of last change:2024/09/06
Final PL
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common_pl_tadalfil5mg20170602
Date of last change:2024/09/06
Final Product Information
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common_pl_tadalfil5mg20170602_2
Date of last change:2024/09/06
Final SPC
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common_spc_tadalafil10mg20170602
Date of last change:2024/09/06
Final SPC
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common_spc_tadalafil20mg20170602
Date of last change:2024/09/06
Final SPC
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common_spc_tadalafil25mg20170602
Date of last change:2024/09/06
Final SPC
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common_spc_tadalafil5 mg20170602
Date of last change:2024/09/06
Final Product Information
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common_spc_tadalafil5 mg20170602_2
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase