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)
Netherlands (NL)
Greece (GR)
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
2025/01/16
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 PL
|
common_pl_clean
Date of last change:2024/09/06
Final SPC
|
common_spc_clean
Date of last change:2024/09/06
Final Labelling
|
Final Labelling
Date of last change:2024/09/06
Final Labelling
|
Updated final agreed common labelling
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase