欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号DE/H/5111/003
药品名称Bupensanduo 8 mg/2 mg Sublingualtabletten
活性成分
    • Buprenorphine hydrochloride 8.64 mg
    • Naloxone hydrochloride dihydrate 2.44 mg
剂型Sublingual tablet
上市许可持有人G.L. Pharma GmbH Schlossplatz 1 8502 LANNACH Austria
参考成员国 - 产品名称Germany (DE)
2199068
互认成员国 - 产品名称
    • Austria (AT)
      Bupensan Duo 8 mg/2 mg-Sublingualtabletten
    • Latvia (LV)
      Bupensanduo 8 mg/2 mg tabletes lietošanai zem mēles
    • Lithuania (LT)
      Bupensanduo 8 mg/2 mg poliežuvinės tabletės
    • Estonia (EE)
    • Czechia (CZ)
      Bupexon
    • Slovakia (SK)
    • Croatia (HR)
      Bupensanduo 8 mg/2 mg sublingvalne tablete
许可日期2018/04/25
最近更新日期2024/10/10
药物ATC编码
    • N07BC51 buprenorphine, combinations
申请类型
  • TypeLevel1:Abridged
  • TypeLevel2:Additional Strength/Form
  • TypeLevel3:Generic Art 10.1 and 10.2 Dir 2001/83/EC
  • TypeLevel4:Chemical Substance
  • TypeLevel5:Prescription Only
附件文件下载
市场状态Positive
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