欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
IT/H/0178/001
药品名称
Letrozolo Mylan Generics Italia
活性成分
letrozole 2.5 mg
剂型
Film-coated tablet
上市许可持有人
Mylan S.p.A. Via Vittor Pisani, 20 20124 Milano Italy
参考成员国 - 产品名称
Italy (IT)
互认成员国 - 产品名称
许可日期
2010/09/13
最近更新日期
2011/12/09
药物ATC编码
L02BG04 letrozole
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
Final SPC
|
1 3 1 SmPC Label and Leaflet DCP via IT 0177 _ DOC 2 Day 106 Tracked Changes
Date of last change:2024/09/06
Final PL
|
1_3_1 Letrozole DCP via IT 0177 Day 160 Tracked Changes
Date of last change:2024/09/06
Final SPC
|
Annex I
Date of last change:2024/09/06
Final SPC
|
Day_120_Quality
Date of last change:2024/09/06
PubAR
|
Day_180_Quality
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase