欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/1562/001
药品名称
Folinato de Cálcio Hikma
活性成分
calcium folinate 10.8 mg
剂型
Solution for injection
上市许可持有人
Hikma Farmacêutica (Portugal), S.A.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
United Kingdom (Northern Ireland) (XI)
France (FR)
Spain (ES)
许可日期
2017/03/15
最近更新日期
2024/02/02
药物ATC编码
V03AF03 calcium folinate
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
Date of last change:2024/02/02
Final Labelling
|
common_outer
Date of last change:2024/02/02
Final SPC
|
common_spc
Date of last change:2024/02/02
PAR
|
601025_20170418_PAR_GBB
Date of last change:2017/07/12
Final Product Information
|
common-pl-calciumfolinate_dcp-v0-mar17-clean
Date of last change:2017/07/12
Final Product Information
|
common-spc-calciumfolinate_dcp-v0-mar17-clean
Date of last change:2017/07/12
Final Product Information
|
common-impack-calciumfoliante_dcp-v0-jan17
Date of last change:2017/07/12
Final Product Information
|
common-outer-calciumfolinate_dcp-v0-30mar17-tracked
Date of last change:2017/07/12
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase