欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DE/H/0483/004
药品名称Beriate 2000
活性成分
    • blood coagulation factor VIII human 2000.0 IU
剂型Powder and solvent for solution for injection
上市许可持有人CSL Behring Emil-von-Behring Str. 76 35041 Marburg
参考成员国 - 产品名称Germany (DE)
Beriate 2000
互认成员国 - 产品名称
    • Austria (AT)
      Beriate 200 I.E./ml Pulver und Lösungsmittel zur Herstellung einer Injektions- oder Infusionslösung
    • Italy (IT)
    • Latvia (LV)
      Beriate 2000 SV pulveris un šķīdinātājs injekciju vai infūziju šķīduma pagatavošanai
    • Portugal (PT)
    • Poland (PL)
      Beriate 2000
    • Bulgaria (BG)
    • Czechia (CZ)
      Beriate® 2000 IU
    • Hungary (HU)
      BERIATE 200 NE/ml por és oldószer oldatos injekcióhoz vagy infúzióhoz
    • Romania (RO)
      Beriate 2000 pulbere şi solvent pentru soluţie injectabilă/perfuzabilă
    • Croatia (HR)
      Beriate 2000 IU prašak i otapalo za otopinu za injekciju ili infuziju
    • Slovenia (SI)
    • Slovakia (SK)
      Beriate 2000
    • Lithuania (LT)
      Beriate 2000 TV milteliai ir tirpiklis injekciniam ar infuziniam tirpalui
    • Estonia (EE)
    • Malta (MT)
许可日期2012/11/16
最近更新日期2025/04/16
药物ATC编码
    • B02BD02 coagulation factor VIII
申请类型
  • TypeLevel1：Known Active Substance
  • 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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