欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2230/001
药品名称
Pirfenidone Newbury
活性成分
pirfenidone 267.0 mg
剂型
Film-coated tablet
上市许可持有人
Newbury Pharmaceuticals AB, Sweden
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Denmark (DK)
Norway (NO)
许可日期
2023/02/09
最近更新日期
2024/04/23
药物ATC编码
L04AX05 pirfenidone
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
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20220208000020
Date of last change:2024/09/06
Final PL
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20220208000020_2
Date of last change:2024/09/06
PubAR
|
PAR
Date of last change:2024/09/06
PubAR Summary
|
PAR Summary
Date of last change:2024/09/06
市场状态
Positive
©2006-2025
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase