欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号AT/H/0190/001
药品名称Haemonine 50 I.E./ml Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
活性成分
    • blood coagulation factor IX human 50.0 IU/ml
剂型Powder and solvent for solution for injection
上市许可持有人Biotest Pharma GmbH Landsteinerstr.5 63303 Dreieich Germany
参考成员国 - 产品名称Austria (AT)
互认成员国 - 产品名称
    • United Kingdom (Northern Ireland) (XI)
    • Germany (DE)
    • Italy (IT)
    • Greece (GR)
许可日期2008/11/22
最近更新日期2016/10/24
药物ATC编码
    • B02BD04 coagulation factor IX
申请类型
  • TypeLevel1:Known Active Substance
  • TypeLevel2:Initial Application
  • TypeLevel3:Full Dossier Art 8.3(i) Dir 2001/83/EC
  • TypeLevel4:Biological: Blood Product
  • TypeLevel5:Prescription Only
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市场状态Positive
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