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
2024/07/15
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_6 RVG 27040_28743_28744
Date of last change:2024/06/28
Final PL
|
common_vials_unidose_pil_clean
Date of last change:2024/06/28
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
市场状态
Positive
©2006-2024
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase