欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/3251/002
药品名称
PIRFENAIR HEXAL
活性成分
pirfenidone 801.0 mg
剂型
Film-coated tablet
上市许可持有人
Hexal A/S Edvard Thomsens Vej 14 2300 Copenhagen S Denmark
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Germany (DE)
PIRFENAIR HEXAL 801 mg Filmtabletten
许可日期
2022/03/17
最近更新日期
2023/12/04
药物ATC编码
L04AX05 pirfenidone
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Multiple (Copy) 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 Labelling
|
Updated final agreed common labelling_2
Date of last change:2022/06/02
Final Labelling
|
Updated final agreed common labelling
Date of last change:2022/06/02
Final Labelling
|
Final Labelling
Date of last change:2022/06/02
Final PL
|
Final PIL
Date of last change:2022/06/02
Final SPC
|
Final SmPC
Date of last change:2022/06/02
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase