欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号AT/H/0373/002
药品名称Prothromplex Total 500 I.E.
活性成分
    • blood coagulation factors II, VII, IX, X in combination (Prothrombin complex) 500.0 IU/17 ml
剂型Powder and solvent for solution for injection
上市许可持有人Takeda Manufacturing Austria AG Industriestraße 67 A-1221 Vienna
参考成员国 - 产品名称Austria (AT)
Prothromplex TOTAL 500 I.E. Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
互认成员国 - 产品名称
    • Norway (NO)
    • Poland (PL)
      Prothromplex Total NF
    • Germany (DE)
    • Latvia (LV)
    • Denmark (DK)
    • Lithuania (LT)
      Prothromplex 500 TV milteliai ir tirpiklis injekciniam tirpalui
    • Belgium (BE)
    • Estonia (EE)
      PROTHROMPLEX TOTAL
    • Netherlands (NL)
      Prothromplex
    • Hungary (HU)
    • Luxembourg (LU)
    • Bulgaria (BG)
    • Ireland (IE)
    • Czechia (CZ)
      Prothromplex Total NF
    • Spain (ES)
    • Romania (RO)
    • Portugal (PT)
    • Slovakia (SK)
    • Italy (IT)
    • Slovenia (SI)
    • Greece (GR)
    • Malta (MT)
许可日期2023/03/15
最近更新日期2024/06/12
药物ATC编码
    • B02BD01 coagulation factor IX, II, VII and X in combination
申请类型
  • TypeLevel1：Line Extension
  • TypeLevel2：Additional Strength/Form
  • 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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