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
2025/11/19
药物ATC编码
V03AF03 calcium folinate
申请类型
TypeLevel1：
Abridged
TypeLevel2：
Initial Application
TypeLevel3：
Generic
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
Final PL
|
common_pl_calciumfolinate_dcp_v008
Date of last change:2025/11/19
Final SPC
|
common_spc_calciumfolinate_dcp_v008
Date of last change:2025/11/19
PubAR
|
601025_20170418_PAR_GBB
Date of last change:2024/09/06
Final Product Information
|
common_impack_calciumfoliante_dcp_v0_jan17
Date of last change:2024/09/06
Final Labelling
|
common_outer
Date of last change:2024/09/06
Final Product Information
|
common_outer_calciumfolinate_dcp_v0_30mar17_tracked
Date of last change:2024/09/06
Final Product Information
|
common_pl_calciumfolinate_dcp_v0_mar17_clean
Date of last change:2024/09/06
Final Product Information
|
common_spc_calciumfolinate_dcp_v0_mar17_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase