欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号SE/H/1070/003
药品名称Octanate LV
活性成分
    • blood coagulation factor VIII human 100.0 IU/ml
剂型Powder and solvent for solution for injection
上市许可持有人Octapharma AB Sweden
参考成员国 - 产品名称Sweden (SE)
互认成员国 - 产品名称
    • Austria (AT)
      Octanate LV 100 I.E./ml Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
    • Latvia (LV)
      Octanate 500 SV/5 ml pulveris un šķīdinātājs injekciju šķīduma pagatavošanai
    • Czech Republic (CZ)
      Octanate (100 IU/ml)
    • Cyprus (CY)
      OCTANATE C PWD AND SOLVENT FOR SOL FOR INJ
    • Lithuania (LT)
      Octanate 100 TV/ml milteliai ir tirpiklis injekciniam tirpalui
    • Poland (PL)
      Octanate LV
    • Italy (IT)
    • Portugal (PT)
    • Spain (ES)
    • France (FR)
    • Ireland (IE)
    • United Kingdom (Northern Ireland) (XI)
    • Luxembourg (LU)
    • Netherlands (NL)
    • Belgium (BE)
      Octanate 100 IU/ml poeder en oplosmiddel voor injectie
    • Denmark (DK)
    • Slovenia (SI)
    • Romania (RO)
      Octanate LV 100 UI/ml pulbere şi solvent pentru soluţie injectabilă
    • Malta (MT)
      Octanate C 100 IU/ml powder and solvent for solution for injection
许可日期2014/10/13
最近更新日期2025/09/08
药物ATC编码
    • B02BD02 coagulation factor VIII
申请类型
  • TypeLevel1：Line Extension
  • TypeLevel2：Additional Strength/Form
  • TypeLevel3：Full Dossier
  • TypeLevel4：Biological: Blood Product
  • TypeLevel5：Prescription Only
附件文件下载
市场状态Positive
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