欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DK/H/0960/003
药品名称
Amlohexal
活性成分
amlodipine besilate 10.0 mg
剂型
Tablet
上市许可持有人
Hexal A/S Edvard Thomsens Vej 14 2300 København S Denmark
参考成员国 - 产品名称
Denmark (DK)
Amlohexal
互认成员国 - 产品名称
Germany (DE)
Ireland (IE)
Austria (AT)
Amlodipin Hexal 10 mg - Tabletten
Italy (IT)
Poland (PL)
Amlopin 5 mg
Hungary (HU)
许可日期
2006/10/11
最近更新日期
2024/04/15
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_0960_001_003_IA_093 _ clean
Date of last change:2022/09/20
Final SPC
|
Amlodipin SPC common _ DK_H_0960_001_003_IA_093 _ 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_pl _ 12_907 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 Labelling
|
1.3.1 spc-label-pl - common-outer-clean - 456 - clean
Date of last change:2019/09/16
市场状态
Positive
©2006-2024
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase