欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/0397/002
药品名称
Sildenafil Pfizer
活性成分
sildenafil citrate 50.0 mg
剂型
Film-coated tablet
上市许可持有人
Laboratórios Pfizer Lda
参考成员国 - 产品名称
Portugal (PT)
Sildenafil Pfizer
互认成员国 - 产品名称
Germany (DE)
Sildenafil Pfizer 50 mg Filmtabletten
Denmark (DK)
Sildenafil Pfizer
United Kingdom (Northern Ireland) (XI)
Austria (AT)
Sildenafil Pfizer 50 mg Filmtabletten
France (FR)
Italy (IT)
Hungary (HU)
SILDENAFIL PFIZER 50 mg filmtabletta
Ireland (IE)
Greece (GR)
Finland (FI)
Malta (MT)
许可日期
2010/12/16
最近更新日期
2024/09/06
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_common_label_track_approved
Date of last change:2024/09/06
Final SPC
|
1_3_1_common_spc_track_approved
Date of last change:2024/09/06
Final PL
|
common_pl_clean_Sildenafil Pfizer_2
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase