欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/0626/001
药品名称
Orlistato Actavis
活性成分
Orlistat 60.0 mg
剂型
Capsule, hard
上市许可持有人
Actavis Group PTC ehf.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Italy (IT)
许可日期
2012/06/18
最近更新日期
2025/01/13
药物ATC编码
A08AB01 orlistat
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 Product Information
|
FINAL COMMON TEXTS
Date of last change:2024/09/06
Final SPC
|
PI Orlistat 120 mg PT_H_626_01_02 Day 160 proposal CL 170412
Date of last change:2024/09/06
Final SPC
|
PI Orlistat 120 mg PT_H_626_01_02 Day 160 proposal TR 170412
Date of last change:2024/09/06
Final SPC
|
PI Orlistat 60 mg PT_H_626_01_02 Day 160 proposal CL 170412
Date of last change:2024/09/06
Final SPC
|
PI Orlistat 60 mg PT_H_626_01_02 Day 160 proposal TR 170412
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase