欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号SE/H/1547/001
药品名称Belkyra
活性成分
    • Deoxycholic acid 10.0 mg/ml
剂型Solution for injection
上市许可持有人Abbvie AB Hemvarnsgatan 9 Solna
参考成员国 - 产品名称Sweden (SE)
互认成员国 - 产品名称
    • United Kingdom (Northern Ireland) (XI)
    • Spain (ES)
    • Portugal (PT)
    • Netherlands (NL)
      Belkyra 10 mg/ml solution for injection
    • Italy (IT)
    • Ireland (IE)
    • Greece (GR)
      BELKYRA
    • Norway (NO)
    • Malta (MT)
      Belkyra 10mg/ml solution
许可日期2016/06/29
最近更新日期2025/01/21
药物ATC编码
    • D11AX24 deoxycholic acid
申请类型
  • TypeLevel1:Known Active Substance
  • 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Positive
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