欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号SE/H/0429/001
药品名称Primovist
活性成分
    • Gadoxetic acid disodium 0.25 mmol/ml
剂型Solution for injection in prefilled syringe
上市许可持有人Bayer AB Sweden
参考成员国 - 产品名称Sweden (SE)
互认成员国 - 产品名称
    • Germany (DE)
    • Belgium (BE)
    • Netherlands (NL)
    • Luxembourg (LU)
    • Ireland (IE)
    • Austria (AT)
      Primovist 0,25 mmol/ml Injektionslösung, Fertigspritze
    • Spain (ES)
    • Portugal (PT)
    • Italy (IT)
    • Greece (GR)
    • Norway (NO)
    • Finland (FI)
    • Poland (PL)
      Primovist
    • Latvia (LV)
      Primovist 0,25 mmol/ml, šķīdums injekcijām pilnšļircē
    • Lithuania (LT)
      Primovist 0,25 mmol/ml injekcinis tirpalas užpildytame švirkšte
    • Estonia (EE)
      PRIMOVIST
    • Hungary (HU)
      PRIMOVIST 0,25 mmol/ml oldatos injekció előretöltött fecskendőben
    • Cyprus (CY)
    • Czechia (CZ)
    • Slovakia (SK)
      Primovist 0,25 mmol/ml
    • Slovenia (SI)
    • Malta (MT)
    • Croatia (HR)
      Primovist 0,25 mmol/ml otopina za injekciju u napunjenoj štrcaljki
    • Bulgaria (BG)
    • Romania (RO)
      Primovist 0,25 mmol/ml soluţie injectabilă în seringă preumplută
    • Iceland (IS)
    • France (FR)
      Promovist 0.25 mmol/ml, solution injectable en seringue preremplie
    • Denmark (DK)
许可日期2004/09/28
最近更新日期2024/04/19
药物ATC编码
    • V08CA10 gadoxetic acid
申请类型
  • TypeLevel1:New Active Substance
  • TypeLevel2:Initial Application
  • TypeLevel3:Full Dossier Article 4.8 Di 65/65
  • TypeLevel4:Chemical Substance
  • TypeLevel5:Prescription Only
附件文件下载
市场状态Positive
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