欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/2768/001
药品名称
Dexmedetomidina Hikma
活性成分
dexmedetomidine 4.0 µg/ml
剂型
Solution for injection/infusion
上市许可持有人
Hikma Farmacêutica (Portugal), S.A.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Germany (DE)
Dexmedetomidin Hikma 4 Mikrogramm/ml Infusionslösung
Belgium (BE)
Dexmedetomidine Hikma 4 microgrammes/ml solution pour perfusion
Netherlands (NL)
Austria (AT)
France (FR)
Spain (ES)
Italy (IT)
许可日期
2023/06/15
最近更新日期
2024/07/26
药物ATC编码
N05CM18 dexmedetomidine
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
PubAR
|
684164_684165_20230109_PAR_ALB
Date of last change:2024/09/06
Final SPC
|
common_spc_dexmedetomidine_dcp_bags_var01 Clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase