欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
NL/H/0673/004
药品名称
Bisoprololfumaraat 5 mg
活性成分
bisoprolol fumarate 5.0 mg
剂型
Film-coated tablet
上市许可持有人
Hexal AG Holzkirchen Germany
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Austria (AT)
许可日期
2008/10/07
最近更新日期
2023/03/21
药物ATC编码
C07AB07 bisoprolol
申请类型
TypeLevel1：
Abridged
TypeLevel2：
Multiple (Copy) 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 Product Information
|
Bisoprolol Hexal_1_3_1 spc_label_pl _ common_outer _ 6_170 _ Clean
Date of last change:2024/09/06
Final Product Information
|
Bisoprolol Hexal_1_3_1 spc_label_pl _ common_pl_125mg25mg375mg75mg _ 26 _ Clean
Date of last change:2024/09/06
Final Product Information
|
Bisoprolol Hexal_1_3_1 spc_label_pl _ common_pl_5mg10mg _ 40 _ Clean
Date of last change:2024/09/06
Final Product Information
|
Bisoprolol Hexal_1_3_1 spc_label_pl _ common_spc_125mg25mg375mg75mg _ 16 _ Clean
Date of last change:2024/09/06
Final Product Information
|
Bisoprolol Hexal_1_3_1 spc_label_pl _ common_spc_5mg10mg _ 25 _ Clean
Date of last change:2024/09/06
Final Labelling
|
common_outer bisoprololfumaraat 673
Date of last change:2024/09/06
Final Labelling
|
common_pl bisoprololfumaraat 1_25mg2_5mg3_75mg7_5mg 673
Date of last change:2024/09/06
Final PL
|
common_pl bisoprololfumaraat 5mg10mg 673
Date of last change:2024/09/06
Final Labelling
|
common_spc bisoprololfumaraat 1_25mg2_5mg3_75mg7_5mg 673
Date of last change:2024/09/06
Final PL
|
common_spc bisoprololfumaraat 5mg 10mg 673
Date of last change:2024/09/06
Final SPC
|
common_spc_125mg25mg375mg75mg
Date of last change:2024/09/06
Final SPC
|
common_spc_5mg10mg
Date of last change:2024/09/06
市场状态
Positive
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Drugfuture
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European Union HMA Authorisation of Medicines DataBase