欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号PT/H/1198/002
药品名称Bosentano Aurobindo
活性成分
    • Bosentan monohydrate 129.08 mg
剂型Film-coated tablet
上市许可持有人Aurobindo Pharma (Portugal), Unipessoal, Lda.
参考成员国 - 产品名称Portugal (PT)
Bosentano Aurobindo
互认成员国 - 产品名称
    • Germany (DE)
      Bosentan PUREN 125 mg Filmtabletten
    • France (FR)
    • Netherlands (NL)
    • Spain (ES)
    • Italy (IT)
    • Croatia (HR)
    • Cyprus (CY)
      BOSENTAN AUROBINDO FC TABS
    • Malta (MT)
      Bosentan Aurobindo 125 mg film-coated tablets
许可日期2015/05/27
最近更新日期2024/12/06
药物ATC编码
    • C02KX01 bosentan
申请类型
  • TypeLevel1：Known Active Substance
  • TypeLevel2：Initial Application
  • 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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