欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/0338/001
药品名称
Alprazolam-ratiopharm 0,25 mg
活性成分
alprazolam 0.25 mg
剂型
Tablet
上市许可持有人
Ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM Germany
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Portugal (PT)
Germany (DE)
许可日期
2002/07/30
最近更新日期
2022/12/12
药物ATC编码
N05BA12 alprazolam
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Generic Article 4.8(a)(iii), first paragraph
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Labelling
|
outer-1.0 mg
Date of last change:2018/03/13
Final Labelling
|
outer-0.25 mg
Date of last change:2018/03/13
Final Labelling
|
outer-0.5 mg
Date of last change:2018/03/13
Final Product Information
|
common-pl-cean combi
Date of last change:2012/10/03
Final SPC
|
common-spc-clean combi
Date of last change:2012/10/03
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase