欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/3249/002
药品名称
Pirfenidone Sandoz
活性成分
pirfenidone 801.0 mg
剂型
Film-coated tablet
上市许可持有人
Sandoz 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
Poland (PL)
Pirfenidone Sandoz
Croatia (HR)
Belgium (BE)
United Kingdom (Northern Ireland) (XI)
Netherlands (NL)
France (FR)
Spain (ES)
Portugal (PT)
Italy (IT)
Sweden (SE)
Norway (NO)
Finland (FI)
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:
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
|
Final Labelling
Date of last change:2022/06/02
Final Labelling
|
Updated final agreed common labelling
Date of last change:2022/06/02
Final SPC
|
Final SmPC
Date of last change:2022/06/02
Final PL
|
Final PIL
Date of last change:2022/06/02
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase