欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
ES/H/0899/001
药品名称
Dediol semanal 75 micrograms soft capsules
活性成分
calcifediol monohydrate 75.0 µg
剂型
Capsule, soft
上市许可持有人
Faes Farma S.A
参考成员国 - 产品名称
Spain (ES)
互认成员国 - 产品名称
Lithuania (LT)
Estonia (EE)
Czechia (CZ)
Hidroferol týdně
Slovakia (SK)
Slovenia (SI)
Poland (PL)
Hidroferol
Latvia (LV)
许可日期
2024/06/12
最近更新日期
2024/06/13
药物ATC编码
A11CC06 calcifediol
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Full Dossier Art 8.3(i) Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Labelling
|
common_labelling 75 mcg clean
Date of last change:2024/09/06
Final PL
|
common_pl 75 mcg clean
Date of last change:2024/09/06
Final SPC
|
common_spc 75 mcg clean AMENDED
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase