欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号IS/H/0487/002
药品名称Balfumon
活性成分
    • dimethyl fumarate 240.0 mg
剂型Gastro-resistant capsule, hard
上市许可持有人G.L. Pharma GmbH Schlossplatz 1, 8502 Lannach, Steiermark, Austria
参考成员国 - 产品名称Iceland (IS)
Balfumon
互认成员国 - 产品名称
    • Finland (FI)
    • Poland (PL)
      Dimethyl fumarate G.L.
    • Hungary (HU)
      DMF G.L
    • Bulgaria (BG)
      DMF G.L.
    • Czechia (CZ)
      DMF G.L.
    • Slovakia (SK)
    • Denmark (DK)
    • Sweden (SE)
    • Norway (NO)
许可日期2023/01/02
最近更新日期2024/08/05
药物ATC编码
    • L04AX07 dimethyl fumarate
申请类型
  • TypeLevel1:Abridged
  • TypeLevel2:Initial Application
  • TypeLevel3:Generic Art 10.1 and 10.2 Dir 2001/83/EC
  • TypeLevel4:Chemical Substance
  • TypeLevel5:Prescription Only
附件文件下载
市场状态Positive
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