欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/1425/001
药品名称
Ofloxacin ELC
活性成分
ofloxacin 3.0 mg/ml
剂型
Eye drops, solution
上市许可持有人
ELC Group, s.r.o.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
许可日期
2016/08/17
最近更新日期
2022/06/30
药物ATC编码
S01AE01 ofloxacin
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
Final Product Information
|
common-spc_2
Date of last change:2017/11/09
Final Product Information
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common-interpack
Date of last change:2017/11/09
Final Product Information
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common-pl_2
Date of last change:2017/11/09
Final Product Information
|
common-spc
Date of last change:2017/11/09
Final Product Information
|
common-interpack
Date of last change:2017/11/09
Final Product Information
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common-pl
Date of last change:2017/11/09
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase