欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号FR/H/0147/005
药品名称Subutex 300mg
活性成分
    • buprenorphine 300.0 mg
剂型SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
上市许可持有人Indivior Europe Limited 27 Windsor Place Dublin 2 Ireland
参考成员国 - 产品名称France (FR)
Subutex Mondepa 300mg
互认成员国 - 产品名称
    • Belgium (BE)
    • Cyprus (CY)
    • Czechia (CZ)
      Subutex Mondepa
    • Lithuania (LT)
      -
    • Luxembourg (LU)
    • Latvia (LV)
    • Portugal (PT)
许可日期2020/10/26
最近更新日期2021/01/25
药物ATC编码
    • N07BC01 buprenorphine
申请类型
  • TypeLevel1:Line Extension
  • TypeLevel2:Initial Application
  • TypeLevel3:Full Dossier Art 8.3(i) Dir 2001/83/EC
  • TypeLevel4:Chemical Substance
  • TypeLevel5:Prescription Only
附件文件下载
    市场状态Withdrawn(注:已撤市)
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