欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
BE/H/0250/001
药品名称
Diazetop
活性成分
Diazepam 2.0 mg
剂型
Tablet
上市许可持有人
Aurobindo SA-NV E. Demunterlaan 5 box 8 1090 Brussel Belgium
参考成员国 - 产品名称
Belgium (BE)
Diazetop 2 mg tabletten
互认成员国 - 产品名称
United Kingdom (Northern Ireland) (XI)
许可日期
2016/09/27
最近更新日期
2024/10/21
药物ATC编码
N05BA01 diazepam
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial 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 PL
|
PIL_clean
Date of last change:2024/10/17
Final SPC
|
SmPC_clean
Date of last change:2024/10/17
Final Product Information
|
Final Labelling
Date of last change:2024/09/06
Final Product Information
|
Final PL
Date of last change:2024/09/06
Final Product Information
|
Final SPC
Date of last change:2024/09/06
Final Labelling
|
Labelling_clean
Date of last change:2024/09/06
PubAR
|
PAR BE_H_250_01_03 Valipam _Diazetop_
Date of last change:2024/09/06
PubAR Summary
|
Summary PAR for generics BE_H_250_01_03 Valipam _Diazetop_
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase