欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DE/H/0481/001
药品名称Berinert 500
活性成分
    • C1-esterase inhibitor human 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 35041 Marburg Germany
参考成员国 - 产品名称Germany (DE)
294.00.00
互认成员国 - 产品名称
    • France (FR)
    • Italy (IT)
    • Finland (FI)
    • Austria (AT)
      Berinert 500 Einheiten Pulver & Lösungsmittel zur Herstellung einer Injektions-oder Infusionslösung
    • Belgium (BE)
    • Netherlands (NL)
    • Iceland (IS)
    • Portugal (PT)
    • Slovenia (SI)
    • Slovakia (SK)
    • Romania (RO)
      BERINERT P, 500 unităţi, pulbere şi solvent pentru soluţie injectabilă/perfuzabilă
    • Czechia (CZ)
    • Cyprus (CY)
    • Bulgaria (BG)
    • Hungary (HU)
      BERINERT 500 Egység por és oldószer oldatos injekcióhoz vagy infúzióhoz
    • Poland (PL)
      Berinert
    • Sweden (SE)
    • Greece (GR)
    • Spain (ES)
    • United Kingdom (Northern Ireland) (XI)
    • Luxembourg (LU)
    • Denmark (DK)
    • Norway (NO)
    • Croatia (HR)
      Berinert 500 IU prašak i otapalo za otopinu za injekciju/infuziju
    • Malta (MT)
      Berinert 500IU Powder and solvent for solution for injection/infusion
    • Estonia (EE)
      BERINERT IV
    • Lithuania (LT)
      Human C1-esterase inhibitor CSL Behring 500 TV milteliai ir tirpiklis injekciniam ar infuziniam tirpalui
    • Ireland (IE)
许可日期2008/12/11
最近更新日期2024/04/24
药物ATC编码
    • B06AC01 c1-inhibitor, plasma derived
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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