欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
HR/H/0194/001
药品名称
Fingolimod JGL
活性成分
fingolimod hydrochloride 0.5 mg
剂型
Capsule, hard
上市许可持有人
Jadran - Galenski laboratorij d.d. Svilno 20 51000 Rijeka Croatia
参考成员国 - 产品名称
Croatia (HR)
互认成员国 - 产品名称
Slovenia (SI)
许可日期
2022/03/10
最近更新日期
2023/07/24
药物ATC编码
L04AA27 fingolimod
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
PubAR Summary
|
Arlesias_PAR Summary
Date of last change:2024/09/06
PubAR
|
Arlesias_PAR_
Date of last change:2024/09/06
Final Product Information
|
common_LAB_inn
Date of last change:2024/09/06
Final Product Information
|
common_LAB_out
Date of last change:2024/09/06
Final Product Information
|
common_PL_2
Date of last change:2024/09/06
Final Product Information
|
common_SmPC_2
Date of last change:2024/09/06
市场状态
Positive
©2006-2025
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase