欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号FR/H/0156/001
药品名称Betafact
活性成分
    • Human Coagulation Factor IX 50.0 IU/ml
剂型Powder and solvent for solution for injection
上市许可持有人Laboratoire Fran‡ais du Fractionnement et des Biotechnologies
参考成员国 - 产品名称France (FR)
互认成员国 - 产品名称
    • Netherlands (NL)
    • Czechia (CZ)
      BETAFACT 50 IU/ml
    • Germany (DE)
    • Slovakia (SK)
    • Luxembourg (LU)
    • Poland (PL)
    • Hungary (HU)
      Betafact 50NE/ml por és oldószer oldatos injekcióhoz
    • Romania (RO)
      BETAFACT 50 UI/ml pulbere si solvent pentru solutie injectabila
    • United Kingdom (GB)
    • Ireland (IE)
许可日期1999/12/22
最近更新日期2023/11/15
药物ATC编码
    • B02BD04 coagulation factor IX
申请类型
  • TypeLevel1：[not specified]
  • TypeLevel2：[not specified]
  • TypeLevel3：Full Dossier Article 4.8 Di 65/65
  • TypeLevel4：Biological: Other
  • TypeLevel5：[not specified]
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