欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/4138/004
药品名称
Sildenafil Sandoz 100 mg, tablets
活性成分
Sildenafil citrate 100.0 µg
剂型
Tablet
上市许可持有人
Sandoz B.V. Veluwezoom 22 Almere, The Netherlands
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Germany (DE)
SildeHEXAL 100 mg Tabletten
许可日期
2018/09/24
最近更新日期
2024/10/24
药物ATC编码
G04BE03 sildenafil
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
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 Labelling
|
1_3_1 spc_label_pl _ common_outer _ 6_323 CLEAN
Date of last change:2024/09/06
Final PL
|
1_3_1_common_pl_002966663_clean
Date of last change:2024/09/06
Final SPC
|
1_3_1_common_spc_002966622_clean
Date of last change:2024/09/06
PubAR
|
190319 NL_H_4138_004_DC Sildenafil Sandoz PAR
Date of last change:2024/09/06
PubAR Summary
|
190319 NL_H_4138_004_DC Sildenafil Sandoz summary EN
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase