欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/0381/001
药品名称
Dotarem 0.5 mmol/ml
活性成分
gadoteric acid 0.5 mmol/ml
剂型
Solution for injection
上市许可持有人
Guerbet 15 rue des Vanesses 93420, Villepinte France
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Germany (DE)
Poland (PL)
Latvia (LV)
Lithuania (LT)
DOTAREM (vienadozis) 0,5mmol/ml injekcinis tirpalas
Estonia (EE)
Cyprus (CY)
DOTAREM SOL FOR INJECTION
Slovakia (SK)
Dotarem 0,5 mmol/ ml
许可日期
2003/05/28
最近更新日期
2024/03/27
药物ATC编码
V08CA02 gadoteric acid
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Full Dossier Article 4.8 Di 65/65
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final SPC
|
common-spc-4 RVG 14203
Date of last change:2018/04/03
Final SPC
|
common-spc-5 RVG 27039
Date of last change:2018/04/03
Final SPC
|
common-spc-6 RVG 27040-28743-28744
Date of last change:2018/04/03
Final PL
|
Dotarem_001 Vials Unidose - Final PIL clean
Date of last change:2015/01/14
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase