欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2208/002
药品名称
Pixxoscan
活性成分
Gadobutrol 1.0 mmol/ml
剂型
Solution for injection in pre-filled syringe
上市许可持有人
GE Healthcare AS, Norway
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Greece (GR)
Germany (DE)
Pixxoscan 1,0 mmol/ml Injektionslösung in einer Fertigspritze
Poland (PL)
Austria (AT)
Pixxoscan 1 mmol/ml Injektionslösung in einer Fertigspritze
France (FR)
Spain (ES)
Portugal (PT)
Italy (IT)
Norway (NO)
许可日期
2023/03/15
最近更新日期
2024/12/18
药物ATC编码
V08CA09 gadobutrol
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20211118000026
Date of last change:2024/09/06
Final SPC
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20211118000026_2
Date of last change:2024/09/06
PubAR
|
PAR
Date of last change:2024/09/06
PubAR Summary
|
PAR Summary
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase