欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号NL/H/4797/001
药品名称Fingolimod Synthon 0.5 mg, hard capsules
活性成分
    • fingolimod hydrochloride 0.5 mg
剂型Capsule, hard
上市许可持有人Synthon B.V. Microweg 22 6545 CM Nijmegen The Netherlands
参考成员国 - 产品名称Netherlands (NL)
互认成员国 - 产品名称
    • Spain (ES)
    • United Kingdom (Northern Ireland) (XI)
    • Belgium (BE)
      Fingolimod Fresenius Kabi 0,5 mg, harde capsules
    • Czechia (CZ)
      Fingolimod Fresenius Kabi
    • Italy (IT)
    • Norway (NO)
    • Poland (PL)
    • Portugal (PT)
许可日期2020/05/07
最近更新日期2022/07/25
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
附件文件下载
市场状态Positive
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