欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/0219/002
药品名称
Claritromicina APceuticals
活性成分
clarithromycin 500.0 mg
剂型
Film-coated tablet
上市许可持有人
APceuticals - Farmacêutica, Lda.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Italy (IT)
许可日期
2009/06/09
最近更新日期
2022/01/07
药物ATC编码
J01FA09 clarithromycin
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-pl-proposedclean
Date of last change:2014/12/30
Final SPC
|
common-spc-proposedclean
Date of last change:2014/12/30
Final Labelling
|
Labelling_250m_en_approved_19-02-2011
Date of last change:2011/02/21
Final Labelling
|
Labelling_500mg_en_approved_19-02-2011
Date of last change:2011/02/21
市场状态
Positive
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