欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PL/H/0754/005
药品名称
Piramil Biso
活性成分
Bisoprolol fumarate 5.0 mg
Ramipril fumarate 10.0 mg
剂型
Capsule, hard
上市许可持有人
Sandoz GmbH Biochemiestrasse 10 Kund, Tirol 6250 Austria
参考成员国 - 产品名称
Poland (PL)
Piramil Biso
互认成员国 - 产品名称
Germany (DE)
RamiBiso HEXAL 10 mg/5 mg Hartkapseln
Italy (IT)
许可日期
2022/03/22
最近更新日期
2025/01/20
药物ATC编码
C09BX ACE inhibitors, other combinations
申请类型
TypeLevel1:
Known Active Substance
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
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Acive substances specifications
Date of last change:2024/09/06
Final Product Information
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analytical_procedure_1
Date of last change:2024/09/06
Final Product Information
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common_interpack
Date of last change:2024/09/06
Final Product Information
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common_pl_2
Date of last change:2024/09/06
Final Product Information
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common_spc_2
Date of last change:2024/09/06
Final Product Information
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FAR Overview PL_H_0752_0757_001_006_DC_clean
Date of last change:2024/09/06
Final Product Information
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PL_H_0752_0757_001_006_DC EOP Letter
Date of last change:2024/09/06
Final Product Information
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Specifications
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase