欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/1575/001
药品名称
Levofloxacina Aurovitas
活性成分
Levofloxacin 5.0 mg/ml
剂型
Solution for infusion
上市许可持有人
Aurovitas Unipessoal, Lda.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Spain (ES)
Italy (IT)
Germany (DE)
许可日期
2017/02/23
最近更新日期
2025/01/09
药物ATC编码
J01MA12 levofloxacin
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
Final PL
|
common_pl_clean
Date of last change:2025/01/09
Final SPC
|
common_spc_clean
Date of last change:2025/01/09
PubAR
|
603602_20170306_PAR_ACM
Date of last change:2024/09/06
Final Product Information
|
Labelling
Date of last change:2024/09/06
Final Product Information
|
PIL
Date of last change:2024/09/06
Final Product Information
|
SPC
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase