欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
IT/H/0308/001
药品名称
TEGLUTIK
活性成分
riluzole 5.0 mg/ml
剂型
Oral suspension
上市许可持有人
Italfarmaco S.p.A. Viale Fulvio Testi, 330 20126 Milano Italy
参考成员国 - 产品名称
Italy (IT)
互认成员国 - 产品名称
France (FR)
Spain (ES)
Cyprus (CY)
Teglutik 5mg/ml oral suspension
Portugal (PT)
Greece (GR)
Finland (FI)
Luxembourg (LU)
Netherlands (NL)
Teglutik 5 mg/ml, suspensie voor oraal gebruik
Germany (DE)
Teglutik 5 mg/ml Suspension zum Einnehmen
Belgium (BE)
United Kingdom (Northern Ireland) (XI)
Norway (NO)
Sweden (SE)
许可日期
2013/07/03
最近更新日期
2024/03/12
药物ATC编码
N07XX02 riluzole
申请类型
TypeLevel1:
Abridged
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 PL
|
common_PL clean
Date of last change:2023/03/30
Final SPC
|
common_SmPC clean
Date of last change:2023/03/30
Final Labelling
|
Labels
Date of last change:2021/11/19
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase