欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
FR/H/0200/003
药品名称
GLUCOVANCE 1000mg/5mg
活性成分
glibenclamide 5.0 mg
metformin 1000.0 mg
剂型
Film-coated tablet
上市许可持有人
MERCK SANTE S.A.S
参考成员国 - 产品名称
France (FR)
互认成员国 - 产品名称
许可日期
2009/12/14
最近更新日期
2024/08/02
药物ATC编码
A10BD02 metformin and sulfonylureas
申请类型
TypeLevel1：
Line Extension
TypeLevel2：
Initial Application
TypeLevel3：
Fixed combination Art 10b Dir 2001/83/EC
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
Final Product Information
|
_Combined_EN_GIR FR_H_181_002 II WS245 2022Mar11 Clean__Combined_EN_GIR FR_H_181_002 II WS245 2022Mar11 Clean
Date of last change:2024/09/06
Final Product Information
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_Combined_EN_GIR FR_H_181_003 II WS245 2022Mar11 Clean__Combined_EN_GIR FR_H_181_003 II WS245 2022Mar11 Clean
Date of last change:2024/09/06
Final Product Information
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_Combined_EN_GLV FR_H_200_003 II WS245 2022Mar11 Clean__Combined_EN_GLV FR_H_200_003 II WS245 2022Mar11 Clean
Date of last change:2024/09/06
Final Product Information
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Combined_EN_GIR FR_H_181_001 II WS245 2022Mar11 Clean__Combined_EN_GIR FR_H_181_001 II WS245 2022Mar11 Clean
Date of last change:2024/09/06
Final Product Information
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Combined_EN_GLV FR_H_200_001 II WS245 2022Mar11 Clean__Combined_EN_GLV FR_H_200_001 II WS245 2022Mar11 Clean
Date of last change:2024/09/06
Final Product Information
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Combined_EN_GLV FR_H_200_002 II WS245 2022Mar11 Clean__Combined_EN_GLV FR_H_200_002 II WS245 2022Mar11 Clean
Date of last change:2024/09/06
Final SPC
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MRP SPC LAB PL metglib Glucovance 500_2_5 WS103_II 2017Aug31 TCsub en
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase