欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/2013/001
药品名称
Azurvig
活性成分
sildenafil 25.0 mg/ml
剂型
Oral suspension
上市许可持有人
Farmalider, S.A.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
France (FR)
Croatia (HR)
Italy (IT)
Greece (GR)
Poland (PL)
Azurvig
Hungary (HU)
AZURVIG 12,5 mg/pumpálásonként belsőleges szuszpenzió
Bulgaria (BG)
Czechia (CZ)
Azurvig
Romania (RO)
Slovakia (SK)
Azurvig 25 mg/ml perorálna suspenzia
许可日期
2018/10/10
最近更新日期
2024/08/09
药物ATC编码
G04BE03 sildenafil
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final SPC
|
common_smpc_clean
Date of last change:2024/08/09
Final PL
|
common_pl_clean_2
Date of last change:2024/08/09
Final Labelling
|
proposed_outer_impack_cln
Date of last change:2024/08/09
Final Product Information
|
common-impack
Date of last change:2019/07/19
Final Product Information
|
common-spc-cln
Date of last change:2019/07/19
Final Product Information
|
common-outer-impack
Date of last change:2019/07/19
Final Product Information
|
common-pl-clean
Date of last change:2019/07/19
PAR
|
2013_PAR_FINAL
Date of last change:2019/07/19
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase