欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
IT/H/0120/001
药品名称
Keplat
活性成分
ketoprofen 20.0 mg
剂型
Medicated plaster
上市许可持有人
Hisamitsu Italia S.r.l. Via Paolo da Cannobio 9 20122 Milano Italy
参考成员国 - 产品名称
Italy (IT)
互认成员国 - 产品名称
Portugal (PT)
Keplat
Hungary (HU)
Czechia (CZ)
许可日期
2005/04/28
最近更新日期
2023/09/07
药物ATC编码
M02AA10 ketoprofen
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Other [Article 10.1.(a)(iii), last paragraph]
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
PIL Keplat clean
Date of last change:2023/05/15
Final SPC
|
SmPC Keplat clean
Date of last change:2023/05/15
Final Labelling
|
common-outer-annotatedkeplat20mgREV
Date of last change:2018/07/02
Final Product Information
|
common-interpack
Date of last change:2016/04/15
Final Product Information
|
common-pl
Date of last change:2016/04/15
Final Product Information
|
common-spc
Date of last change:2016/04/15
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase