欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
RO/H/0121/002
药品名称
CEREX
活性成分
capecitabine 500.0 mg
剂型
Film-coated tablet
上市许可持有人
Terapia SA former SE/H/1270/002/DC
参考成员国 - 产品名称
Romania (RO)
Cerex 500mg comprimate filmate
互认成员国 - 产品名称
许可日期
2013/03/08
最近更新日期
2023/09/27
药物ATC编码
L01BC06 capecitabine
申请类型
TypeLevel1:
Known Active Substance
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 Product Information
|
Cerex common PL_ clean
Date of last change:2024/09/06
Final PL
|
Cerex common PL_v 004
Date of last change:2024/09/06
Final Product Information
|
Cerex common SmPC _clean
Date of last change:2024/09/06
Final SPC
|
Cerex common SmPC _v 004
Date of last change:2024/09/06
PubAR
|
Cerex_20film_coated_20tablet_pdf
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase