欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/0303/002
药品名称
Ciprofloxacine 500 mg
活性成分
ciprofloxacin 500.0 mg
剂型
Film-coated tablet
上市许可持有人
Hexal AG Industriestr. 25 83607 Holzkirchen Germany
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Germany (DE)
许可日期
2002/01/16
最近更新日期
2024/06/27
药物ATC编码
J01MA02 ciprofloxacin
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Generic Article 4.8(a)(iii), first paragraph
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
1.3.1 spc-label-pl - common-pl - 12,296
Date of last change:2021/06/04
Final SPC
|
1.3.1 spc-label-pl - common-spc - 11,817
Date of last change:2021/06/04
Final Product Information
|
1.3.1 spc-label-pl - common-pl - 10,157 clean
Date of last change:2019/04/01
Final Product Information
|
1.3.1 spc-label-pl - common-spc - 9,603 clean
Date of last change:2019/04/01
Final Labelling
|
Final common labelling text Ciprofloxacin Sandoz NLH0301-0303-0305
Date of last change:2018/09/17
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase