欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
AT/H/1200/001
药品名称
Pirfenidone Day Zero
活性成分
pirfenidone 267.0 mg
剂型
Film-coated tablet
上市许可持有人
Day Zero ehf., Reykjavíkurvegi 62, 220 Hafnarfjördur, Iceland
参考成员国 - 产品名称
Austria (AT)
互认成员国 - 产品名称
Germany (DE)
Pirfenidone Day Zero 267 mg Filmtabletten
许可日期
2022/03/02
最近更新日期
2022/05/05
药物ATC编码
L04AX05 pirfenidone
申请类型
TypeLevel1:
Known Active Substance
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
PAR
|
PAR_scientific_discussion_AT_H_1200_001_002_DC_UA
Date of last change:2022/05/05
Final Labelling
|
Final_LAB_AT_H_1200_001_002_DC
Final PL
|
Final_PIL_AT_H_1200_001_002_DC
Final SPC
|
Final_SmPC_AT_H_1200_001_002_DC
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase