欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
IT/H/0608/003
药品名称
DISTEOMIN
活性成分
cholecalciferol 20000.0 IU/ml
剂型
Oral solution
上市许可持有人
OP Pharma S.r.l. Via Monte Rosa 61 20149 Milano Italy
参考成员国 - 产品名称
Italy (IT)
VIDOIL
互认成员国 - 产品名称
Greece (GR)
Portugal (PT)
Spain (ES)
许可日期
2019/08/12
最近更新日期
2024/02/07
药物ATC编码
A11CC05 colecalciferol
申请类型
TypeLevel1：
Known Active Substance
TypeLevel2：
Initial Application
TypeLevel3：
Bibliographic Art 10 a Dir 2001/83/EC
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
Final PL
|
pl clean
Date of last change:2022/06/02
Final SPC
|
smpc clean
Date of last change:2022/06/02
Final Product Information
|
inner label_Common lab inner 50 000 UI
Date of last change:2022/06/02
Final Product Information
|
Smpc_SmpC Common 50 000 UI
Date of last change:2022/06/02
Final Product Information
|
PIL_PIL Common 50 000 UI
Date of last change:2022/06/02
Final Product Information
|
PIL tracked_pl_tracked
Date of last change:2022/06/02
Final Product Information
|
Outer label_Common lab outer 50 000 UI
Date of last change:2022/06/02
Final Product Information
|
Smpc tracked_smpc_tracked
Date of last change:2022/06/02
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase