欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
AT/H/1201/002
药品名称
Gunacresa
活性成分
pirfenidone 801.0 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
Italy (IT)
许可日期
2022/03/02
最近更新日期
2023/01/19
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
Final SPC
|
final_common_SPC_AT_H_1201_001_002_IB_001_clean
Date of last change:2023/01/19
Final PL
|
final_common_PIL_AT_H_1201_001_002_IB_001_clean
Date of last change:2023/01/19
Final Labelling
|
final_common_LAB_AT_H_1201_001_002_IB_001_clean
Date of last change:2023/01/19
市场状态
Positive
©2006-2024
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase