欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DE/H/3699/001
药品名称
Valedonis 75 mg Filmtabletten
活性成分
sildenafil 75.0 mg
剂型
Film-coated tablet
上市许可持有人
TEVA GmbH Graf-Arco-Str. 3 89079 Ulm Germany
参考成员国 - 产品名称
Germany (DE)
Siria 75 mg Filmtabletten
互认成员国 - 产品名称
许可日期
2013/06/19
最近更新日期
2019/09/09
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
PubAR
|
01_DE_3699_3700_1_2161_4_DC Sildenafil_mepha_Final PAR
Date of last change:2024/09/06
Final Product Information
|
common_final_pl_3699
Date of last change:2024/09/06
Final Product Information
|
common_final_pl_3700
Date of last change:2024/09/06
Final Product Information
|
common_final_spc_3699
Date of last change:2024/09/06
Final Product Information
|
common_final_spc_3700
Date of last change:2024/09/06
Final Labelling
|
Valedonis 75mg _Sildenafil__BL_DE_H_3699_001_d0_12_2_13_clean
Date of last change:2024/09/06
Final Labelling
|
Valedonis 75mg _Sildenafil__BL_DE_H_3699_001_d0_12_2_13_tracked
Date of last change:2024/09/06
Final Labelling
|
Valedonis 75mg _Sildenafil__FS_DE_H_3699_001_d0_12_02_13_clean
Date of last change:2024/09/06
Final Labelling
|
Valedonis 75mg _Sildenafil__FS_DE_H_3699_001_d0_12_02_13_tracked
Date of last change:2024/09/06
Final PL
|
Valedonis 75mg _Sildenafil__GI_DE_H_3699_001_d0_12_02_13_clean
Date of last change:2024/09/06
Final PL
|
Valedonis 75mg _Sildenafil__GI_DE_H_3699_001_d0_12_02_13_tracked
Date of last change:2024/09/06
Final SPC
|
Valedonis 75mg _Sildenafil__SPC_DE_H_3699_001_d0_12_02_13_clean
Date of last change:2024/09/06
Final SPC
|
Valedonis 75mg _Sildenafil__SPC_DE_H_3699_001_d0_12_02_13_tracked
Date of last change:2024/09/06
市场状态
Withdrawn（注：已撤市）
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European Union HMA Authorisation of Medicines DataBase