欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号DE/H/5452/002
药品名称Gadograf 1,0 mmol/ml Injektionslösung in Fertigspritzen
活性成分
    • gadobutrol 604.72 mg
剂型Solution for injection in pre-filled syringe
上市许可持有人Jenapharm GmbH & Co. KG Otto-Schott-Str. 15 DE-07745 Jena Germany
参考成员国 - 产品名称Germany (DE)
Gadograf 1,0 mmol/ml Injektionslösung (PFS)
互认成员国 - 产品名称
    • Netherlands (NL)
    • Luxembourg (LU)
    • United Kingdom (Northern Ireland) (XI)
    • France (FR)
    • Portugal (PT)
    • Italy (IT)
    • Norway (NO)
      Gadograf
    • Lithuania (LT)
      Kiralda 1,0 mmol/ml injekcinis tirpalas užpildytame švirkšte
    • Bulgaria (BG)
      Gadograf
    • Romania (RO)
    • Malta (MT)
      Gadograf 1.0 mmol/ml solution for injection in prefilled syringe
许可日期2019/06/19
最近更新日期2024/04/19
药物ATC编码
    • V08CA09 gadobutrol
申请类型
  • TypeLevel1:Abridged
  • TypeLevel2:Additional Strength/Form
  • TypeLevel3:Informed Consent Art 10c Dir 2001/83/EC
  • TypeLevel4:Chemical Substance
  • TypeLevel5:Prescription Only
附件文件下载
市场状态Positive
©2006-2024 Drugfuture->European Union HMA Authorisation of Medicines DataBase