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
2024/07/05
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
|
1_3_1 spc_label_pl _ common_outer _ 4_803_clean
Date of last change:2024/09/06
Final Product Information
|
common_pil
Date of last change:2024/09/06
Final PL
|
common_pl_clean
Date of last change:2024/09/06
Final Product Information
|
common_spc
Date of last change:2024/09/06
Final SPC
|
common_spc_clean
Date of last change:2024/09/06
Final Product Information
|
NL_H_0355_001_003_1B_029G_IB variation _ Alprazolam Sandoz
Date of last change:2024/09/06
Final Product Information
|
NL_pil _ RMS comments final
Date of last change:2024/09/06
Final Product Information
|
NL_spc _ RMS comments final
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase