欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0961/002
药品名称
Dipinosticht
活性成分
amlodipine besilate 10.0 mg
剂型
Tablet
上市许可持有人
Hexal AG Industriestr. 25 D-83607 Holzkirchen Germany
参考成员国 - 产品名称
Denmark (DK)
Dipinosticht
互认成员国 - 产品名称
许可日期
2006/10/11
最近更新日期
2023/03/31
药物ATC编码
C08CA01 amlodipine
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 PL
|
Amlodipin PIL common _ DK_H_0961_001_002_IA_081 _ clean
Date of last change:2022/09/20
Final SPC
|
Amlodipin SPC common _ DK_H_0961_001_002_IA_081 _ clean
Date of last change:2022/09/20
Final Product Information
|
1_3_1 spc_label_pl _ common_spc _ 12_445 clean
Date of last change:2022/06/02
Final Product Information
|
1_3_1 spc_label_pl _ common_outer_clean _ 469
Date of last change:2022/06/02
Final Product Information
|
1_3_1 spc_label_pl _ common_pl _ 12_907 clean
Date of last change:2022/06/02
Final Labelling
|
1.3.1 spc-label-pl - common-outer-clean - 456 - clean
Date of last change:2019/09/16
市场状态
Withdrawn(注:已撤市)
©2006-2024
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European Union HMA Authorisation of Medicines DataBase