欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号NL/H/4948/001
药品名称Fingolimod 0.5 mg Capsules, Hard
活性成分
    • fingolimod hydrochloride 0.5 mg
剂型Capsule, hard
上市许可持有人Biocon Pharma Malta I Limited The Victoria Centre Unit 2, Lower Ground Floor Valletta Road, Mosta MST 9012 Malta
参考成员国 - 产品名称Netherlands (NL)
互认成员国 - 产品名称
    • Germany (DE)
      Fingolimod Biocon 0.5 mg Hartkapsel
    • Austria (AT)
    • Spain (ES)
许可日期2021/12/16
最近更新日期2022/04/22
药物ATC编码
    • L04AA27 fingolimod
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
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市场状态Positive
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