欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号DE/H/5452/001
药品名称Gadograf 1,0 mmol/ml Injektionslösung
活性成分
    • Gadobutrol 604.72 mg
剂型Solution for injection
上市许可持有人Jenapharm GmbH & Co. KG Otto-Schott-Str. 15 D-07745 Jena
参考成员国 - 产品名称Germany (DE)
Gadograf 1,0 mmol/ml Injektionslösung (Vials)
互认成员国 - 产品名称
    • Luxembourg (LU)
    • United Kingdom (Northern Ireland) (XI)
    • Portugal (PT)
    • Italy (IT)
    • Lithuania (LT)
      Kiralda 1,0 mmol/ml injekcinis tirpalas
    • Bulgaria (BG)
      Gadograf
    • Romania (RO)
许可日期2019/06/19
最近更新日期2025/02/13
药物ATC编码
    • V08CA09 gadobutrol
申请类型
  • TypeLevel1:Abridged
  • TypeLevel2:Initial Application
  • TypeLevel3:Informed Consent Art 10c Dir 2001/83/EC
  • TypeLevel4:Chemical Substance
  • TypeLevel5:Prescription Only
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市场状态Positive
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