欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/5494/001
药品名称
Emylif
活性成分
riluzole 50.0 mg
剂型
Orodispersible film
上市许可持有人
ZAMBON S.p.A. Via Lillo Del Duca Bresso MI 20091 Italy
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
France (FR)
Spain (ES)
Portugal (PT)
Italy (IT)
Sweden (SE)
Norway (NO)
Germany (DE)
EMYLIF 50 mg Schmelzfilm
Finland (FI)
Denmark (DK)
Belgium (BE)
Luxembourg (LU)
Iceland (IS)
Austria (AT)
许可日期
2022/10/25
最近更新日期
2024/01/09
药物ATC编码
N07XX02 riluzole
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Product Information
|
131_common_combined_clean
Date of last change:2024/09/06
Final Labelling
|
131_common_Labeling_V003_clean_2
Date of last change:2024/09/06
Final PL
|
131_common_PIL_V003_clean_3
Date of last change:2024/09/06
Final SPC
|
131_common_SmPC_V003_clean
Date of last change:2024/09/06
PubAR
|
PAR_5494_Emylif_20Jan2023
Date of last change:2024/09/06
PubAR Summary
|
sPAR_5494_Emylif_20Jan2023_EN
Date of last change:2024/09/06
市场状态
Positive
©2006-2025
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase