欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
FI/H/1133/001
药品名称
Methenamine hippurate 1 g
活性成分
methenamine hippurate 1.0 g
剂型
Tablet
上市许可持有人
Orion Corporation Orionintie 1 02200 ESPOO
参考成员国 - 产品名称
Finland (FI)
互认成员国 - 产品名称
Sweden (SE)
Norway (NO)
许可日期
2023/07/19
最近更新日期
2023/12/21
药物ATC编码
J01XX05 methenamine
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Labelling
|
EU Methenamine hippurate Orion 1g tabl LABEL 230522
Date of last change:2023/12/28
Final SPC
|
EU Methenamine hippurate Orion 1g tabl SPC 210223
Date of last change:2023/12/28
Final PL
|
EU Methenamine hippurate Orion 1g tabl PIL 210223
Date of last change:2023/12/28
PAR
|
PAR Scientific discussion Methenamine hippurate Orion FI_H_1133_001_DC
Date of last change:2023/12/28
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase