欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2272/001
药品名称
Delipam
活性成分
oxazepam 5.0 mg
剂型
Tablet
上市许可持有人
2care4 Generics ApS
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Norway (NO)
许可日期
2023/05/03
最近更新日期
2024/02/15
药物ATC编码
N05BA04 oxazepam
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 SPC
|
Delipam
Date of last change:2024/09/06
Final PL
|
Delipam_2
Date of last change:2024/09/06
PubAR
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20220421000029
Date of last change:2024/09/06
PubAR Summary
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20220421000029_2
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase