欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DE/H/0247/002
药品名称Gadovist 1.0 mmol/ml Injektionslösung in Fertigspritzen/Patronen
活性成分
    • gadobutrol 604.72 mg
剂型Solution for injection
上市许可持有人Bayer Vital GmbH D-51368 Leverkusen
参考成员国 - 产品名称Germany (DE)
互认成员国 - 产品名称
    • Denmark (DK)
    • Belgium (BE)
    • Netherlands (NL)
    • Luxembourg (LU)
      Gadovist
    • United Kingdom (Northern Ireland) (XI)
      Gadovist
    • Ireland (IE)
    • Austria (AT)
      Gadovist 0,5 mmol/ml-Injektionsl”sung
    • France (FR)
      GADOVIST
    • Spain (ES)
    • Portugal (PT)
    • Italy (IT)
    • Greece (GR)
    • Sweden (SE)
      Gadovist
    • Norway (NO)
    • Finland (FI)
许可日期2000/12/21
最近更新日期2011/11/14
药物ATC编码
    • V VARIOUS
    • V08 CONTRAST MEDIA
    • V08C MAGNETIC RESONANCE IMAGING CONTRAST MEDIA
    • V08CA Paramagnetic contrast media
    • V08CA09 gadobutrol
申请类型
  • TypeLevel1：New Active Substance
  • TypeLevel2：Additional Strength/Form
  • 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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