欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/0684/006
药品名称
Bisoprololfumaraat 10 mg
活性成分
Bisoprolol fumarate 7.5 mg
剂型
Film-coated tablet
上市许可持有人
Sandoz B.V. Almere The Netherlands
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Denmark (DK)
Belgium (BE)
United Kingdom (Northern Ireland) (XI)
Austria (AT)
France (FR)
Spain (ES)
Italy (IT)
Sweden (SE)
Norway (NO)
Finland (FI)
Poland (PL)
Hungary (HU)
Slovenia (SI)
许可日期
2008/10/07
最近更新日期
2025/01/29
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 Sandoz_1_3_1 spc_label_pl _ common_outer _ 6_170 _ Clean
Date of last change:2024/09/06
Final Product Information
|
Bisoprolol Sandoz_1_3_1 spc_label_pl _ common_pl_125mg25mg375mg75mg _ 26 _ Clean
Date of last change:2024/09/06
Final Product Information
|
Bisoprolol Sandoz_1_3_1 spc_label_pl _ common_pl_5mg10mg _ 40 _ Clean
Date of last change:2024/09/06
Final Product Information
|
Bisoprolol Sandoz_1_3_1 spc_label_pl _ common_spc_125mg25mg375mg75mg _ 16 _ Clean
Date of last change:2024/09/06
Final Product Information
|
Bisoprolol Sandoz_1_3_1 spc_label_pl _ common_spc_5mg10mg _ 25 _ Clean
Date of last change:2024/09/06
Final SPC
|
clean _ common_spc_125mg25mg375mg75mg
Date of last change:2024/09/06
Final SPC
|
clean _ common_spc_5mg10mg_2
Date of last change:2024/09/06
Final PL
|
common PL 125mg25mg375mg75mg_0684
Date of last change:2024/09/06
Final Labelling
|
common_outer bisoprololfumaraat sandoz 684
Date of last change:2024/09/06
Final Labelling
|
common_pl bisoprololfumaraat sandoz 125mg25mg375mg75mg 684
Date of last change:2024/09/06
Final PL
|
common_pl_5mg10mg_0684
Date of last change:2024/09/06
Final Labelling
|
common_spc bisoprololfumaraat sandoz 125mg25mg375mg75mg 684
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase