欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
IT/H/0608/001
药品名称
DISTEOMIN
活性成分
cholecalciferol 10000.0 IU/ml
剂型
Oral drops, 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
Spain (ES)
Portugal (PT)
Greece (GR)
Germany (DE)
VIDOIL
许可日期
2019/08/12
最近更新日期
2024/11/08
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 Labelling
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common_lab_inner
Date of last change:2024/09/06
Final Labelling
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common_lab_outer
Date of last change:2024/09/06
Final Product Information
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common_pil_drops_cl_agreed during RUP
Date of last change:2024/09/06
Final PL
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common_pil_drops_clean
Date of last change:2024/09/06
Final Product Information
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common_pil_drops_TRACKED _AGREED DURING RUP
Date of last change:2024/09/06
Final Product Information
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common_spc_drops_cl_agreed during RUP
Date of last change:2024/09/06
Final SPC
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common_spc_drops_clean
Date of last change:2024/09/06
Final Product Information
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common_spc_drops_TRACKED AGREED DURING RUP
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase