欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DE/H/0477/002
药品名称Beriplex P/N 500
活性成分
    • blood coagulation factors II, VII, IX, X in combination (Prothrombin complex) 500.0 IU
剂型Powder and solvent for solution for injection
上市许可持有人CSL-Behring GmbH Emil-von-Behring-Str. 76 D 35041 Marburg Germany
参考成员国 - 产品名称Germany (DE)
Beriplex P/N 500
互认成员国 - 产品名称
    • Belgium (BE)
    • Netherlands (NL)
    • Luxembourg (LU)
    • United Kingdom (Northern Ireland) (XI)
    • Austria (AT)
    • France (FR)
    • Spain (ES)
    • Portugal (PT)
    • Italy (IT)
    • Greece (GR)
    • Sweden (SE)
    • Norway (NO)
    • Finland (FI)
    • Poland (PL)
    • Cyprus (CY)
    • Denmark (DK)
    • Bulgaria (BG)
    • Czechia (CZ)
      Beriplex P/N 500
    • Ireland (IE)
    • Romania (RO)
      Beriplex P/N 500 UI pulbere și solvent pentru soluție injectabilă
    • Croatia (HR)
    • Malta (MT)
    • Slovenia (SI)
    • Slovakia (SK)
    • Hungary (HU)
      BERIPLEX P/N 500 por és oldószer oldatos injekcióhoz
许可日期2008/01/11
最近更新日期2024/04/12
药物ATC编码
    • B02BD01 coagulation factor IX, II, VII and X in combination
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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