欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DK/H/2779/002
药品名称
Orimet
活性成分
metformin hydrochloride 750.0 mg
剂型
Prolonged-release tablet
上市许可持有人
Orion Corporation Orionintie 1 FI-02200 Espoo Finland
参考成员国 - 产品名称
Denmark (DK)
Orimet
互认成员国 - 产品名称
许可日期
2018/06/20
最近更新日期
2022/07/04
药物ATC编码
A10BA02 metformin
申请类型
TypeLevel1：
Abridged
TypeLevel2：
Additional Strength/Form
TypeLevel3：
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
Final Labelling
|
EU Metformin hydrochloride prolonged release tabl DCP LABEL 270318
Date of last change:2024/09/06
Final PL
|
EU Metformin hydrochloride prolonged release tabl DCP PIL 190418
Date of last change:2024/09/06
Final SPC
|
EU Metformin hydrochloride prolonged release tablet DCP SPC 190418
Date of last change:2024/09/06
PubAR
|
Final PAR Orimet prolonged release tablets DKH2779_001_003_DC
Date of last change:2024/09/06
PubAR Summary
|
Final sPAR Orimet DKH2779_001_002_DC
Date of last change:2024/09/06
市场状态
Withdrawn（注：已撤市）
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European Union HMA Authorisation of Medicines DataBase