欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/1363/002
药品名称
Bisoprolol fumaraat Nucleus 5 mg tabletten
活性成分
bisoprolol fumarate 5.0 mg
剂型
Tablet
上市许可持有人
Nucleus ehf. Reykjavik Iceland
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
许可日期
2010/01/13
最近更新日期
2020/01/10
药物ATC编码
C07AB07 bisoprolol
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
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
|
common_outer_clean 5 mg
Date of last change:2024/09/06
Final PL
|
common_pl_clean
Date of last change:2024/09/06
Final Product Information
|
LAB_Bisoprolol_NL_H_1363_R01_v1_0_proposed_20130801
Date of last change:2024/09/06
Final Product Information
|
PIL_Bisoprolol_NL_H_1363_R01_v1_1_1_proposed_20131010_CL
Date of last change:2024/09/06
Final Product Information
|
SmPC_Bisoprolol_NL_H_1363_R01_v1_0_proposed_20130801_CL
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase