欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0681/001
药品名称
Roxithromycin "Orifarm"
活性成分
roxithromycin 150.0 mg
剂型
Film-coated tablet
上市许可持有人
Orifarm A/S Energivej 15 DK-5260 Odense S Denmark
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Finland (FI)
许可日期
2005/06/21
最近更新日期
2019/12/05
药物ATC编码
J01FA06 roxithromycin
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Generic [Article 10.1.(a)(iii), first paragraph]
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Labelling
|
Roxithromycin Orifarm FCT 150 mg 20171110 LAB ENG A5364 VBE
Date of last change:2024/09/06
Final PL
|
Roxithromycin Orifarm FCT 2010404 PIL ENG A5364 MABKE
Date of last change:2024/09/06
Final SPC
|
Roxithromycin Orifarm FCT 20180404 SPC ENG A5364 MABKE
Date of last change:2024/09/06
Final Labelling
|
Roxithromycin Orifarm FCT 300 mg 20171110 LAB ENG A5364 VBE
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase