欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/0705/001
药品名称
Levofloxacina Normon
活性成分
levofloxacin hemihydrate 5.0 mg/ml
剂型
Solution for infusion
上市许可持有人
Laboratórios Normon, S.A.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
许可日期
2012/06/06
最近更新日期
2024/08/02
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_leaflet_levofloxacin_proposed_clean
Date of last change:2024/09/06
Final Product Information
|
common_leaflet_levofloxacin_proposed_final_05_06_2014_clean
Date of last change:2024/09/06
Final Labelling
|
common_outer_levofloxacin_proposed_clean
Date of last change:2024/09/06
Final Product Information
|
common_outer_levofloxacin_proposed_final_05_06_2014_clean
Date of last change:2024/09/06
Final SPC
|
common_spc_levofloxacin_proposed_clean
Date of last change:2024/09/06
Final Product Information
|
common_spc_levofloxacin_proposed_final_05_06_2014_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase