欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/0219/001
药品名称
Claritromicina APceuticals
活性成分
clarithromycin 250.0 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
2024/05/24
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_proposed_clean
Date of last change:2024/09/06
Final SPC
|
common_spc_250mg_500mg_proposed_clean
Date of last change:2024/09/06
Final Labelling
|
Labelling_250m_en_approved_19_02_2011
Date of last change:2024/09/06
Final Labelling
|
Labelling_500mg_en_approved_19_02_2011
Date of last change:2024/09/06
市场状态
Positive
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