欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号DE/H/4900/001
药品名称Fibryga
活性成分
    • fibrinogen 1.0 g
剂型Powder and solvent for solution for injection
上市许可持有人Octapharma GmbH Elisabeth-Selbert-Str. 11 40764 Langenfeld Germany
参考成员国 - 产品名称Germany (DE)
Fibryga
互认成员国 - 产品名称
    • Sweden (SE)
    • Bulgaria (BG)
    • Cyprus (CY)
      Fibryga 1gr κόνις και διαλ'υτης για ενέσιμο διάλυμα-έγχυση
    • Estonia (EE)
      FIBRYGA
    • Spain (ES)
    • France (FR)
    • Croatia (HR)
      Fibryga 1 g prašak i otapalo za otopinu za injekciju/infuziju
    • Ireland (IE)
    • Iceland (IS)
    • Italy (IT)
    • Lithuania (LT)
      Fibryga 1 g milteliai ir tirpiklis injekciniam ar infuziniam tirpalui
    • Latvia (LV)
      Fibryga 1 g pulveris un šķīdinātājs injekciju/infūziju šķīduma pagatavošanai
    • Netherlands (NL)
    • Romania (RO)
      Fibryga 1 g, pulbere și solvent pentru soluţie injectabilă/perfuzabilă
    • Denmark (DK)
    • Belgium (BE)
      Fibryga 1g Poudre pour solution injectable/pour perfusion
    • Luxembourg (LU)
    • United Kingdom (Northern Ireland) (XI)
    • Austria (AT)
      FIBRYGA 1 g Pulver zur Herstellung einer Injektions-/Infusionslösung
    • Portugal (PT)
    • Norway (NO)
      Fibryga
    • Finland (FI)
    • Poland (PL)
      Fibryga
    • Hungary (HU)
      FIBRYGA 1 g por és oldószer oldatos injekcióhoz vagy infúzióhoz
    • Czechia (CZ)
      Fibryna
    • Slovakia (SK)
    • Slovenia (SI)
    • Malta (MT)
      Fibryga 1 g, powder and solvent for solution for injection/infusion
许可日期2017/05/22
最近更新日期2024/04/16
药物ATC编码
    • B02BB01 fibrinogen, human
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
附件文件下载
市场状态Positive
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