欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
NL/H/0355/003
药品名称
Alprazolam Sandoz 1 mg, tabletten
活性成分
alprazolam 1.0 mg
剂型
Tablet
上市许可持有人
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE/NL
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Belgium (BE)
Portugal (PT)
Italy (IT)
许可日期
2002/10/30
最近更新日期
2024/04/29
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 PL
|
common-pl-clean
Date of last change:2020/05/02
Final SPC
|
common-spc-clean
Date of last change:2020/05/02
Final Labelling
|
1.3.1 spc-label-pl - common-outer - 4,803_clean
Date of last change:2018/11/10
Final Product Information
|
common-spc
Date of last change:2013/07/02
Final Product Information
|
NL_H_0355_001-003_1B_029G_IB variation - Alprazolam Sandoz
Date of last change:2013/07/02
Final Product Information
|
common-pil
Date of last change:2013/07/02
Final Product Information
|
NL-spc - RMS comments final
Date of last change:2013/07/02
Final Product Information
|
NL-pil - RMS comments final
Date of last change:2013/07/02
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase