欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/1629/001
药品名称
Linezolida Aurobindo
活性成分
Linezolid 2.0 mg/ml
剂型
Solution for infusion
上市许可持有人
Aurobindo Pharma (Portugal), Unipessoal, Lda.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Germany (DE)
Linezolid PUREN 2 mg/ml Infusionslösung
France (FR)
Spain (ES)
Italy (IT)
Poland (PL)
Linezolid Aurovitas
许可日期
2017/07/12
最近更新日期
2024/11/15
药物ATC编码
J01XX08 linezolid
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
PubAR Summary
|
605482_20170725_PAR_GBB
Date of last change:2024/09/06
Final PL
|
common_pl
Date of last change:2024/09/06
Final SPC
|
common_spc
Date of last change:2024/09/06
Final Labelling
|
Linezolid Aurobindo Labelling_Clean
Date of last change:2024/09/06
Final Product Information
|
PIL_clean
Date of last change:2024/09/06
Final Product Information
|
SPC_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase