欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/0814/002
药品名称
Amlober 10 mg tabletten, tabletten
活性成分
amlodipine besilate 10.0 mg
剂型
Tablet
上市许可持有人
Krka, d.d. Novo Mesto, Slovenia
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Denmark (DK)
Amlodipin "Krka"
Sweden (SE)
Amlodipin Krka
Finland (FI)
许可日期
2006/08/22
最近更新日期
2023/08/21
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 Labelling
|
Labelling_clean
Date of last change:2022/08/09
Final SPC
|
NLH_0814_001-002_IB_015 common SPC clean
Date of last change:2019/02/14
Final Product Information
|
Amlodipine besilate-tablets,NL-Common QRD--SmPCPIL102782_1
Date of last change:2018/03/23
Final PL
|
Common SmPC NL_H_0814
Date of last change:2013/04/25
Final PL
|
Common PIL NL_H_0814
Date of last change:2013/04/25
市场状态
Positive
©2006-2024
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase