欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
FR/H/0147/003
药品名称
Subutex
活性成分
Buprenorphine 8.0 mg
剂型
Sublingual tablet
上市许可持有人
RB PHARMACEUTICALS LIMITED
参考成员国 - 产品名称
France (FR)
互认成员国 - 产品名称
Belgium (BE)
Luxembourg (LU)
Portugal (PT)
Latvia (LV)
Lithuania (LT)
Cyprus (CY)
Czechia (CZ)
许可日期
1999/11/02
最近更新日期
2024/12/13
药物ATC编码
N02AE01 buprenorphine
申请类型
TypeLevel1:
[not specified]
TypeLevel2:
[not specified]
TypeLevel3:
Full Dossier Article 4.8 Di 65/65
TypeLevel4:
[not specified]
TypeLevel5:
[not specified]
附件文件下载
Final Labelling
|
Combined QRD _ Subutex 8mg Sublingual Tablets _ tracked
Date of last change:2024/09/18
Final Product Information
|
Combined QRD _ Subutex 0_4mg Sublingual Tablets _ tracked
Date of last change:2024/09/18
Final SPC
|
Combined QRD _ Subutex 2mg Sublingual Tablets _ tracked
Date of last change:2024/09/18
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase