欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号DK/H/3109/001
药品名称Fingolimod Glenmark
活性成分
    • fingolimod hydrochloride 0.56 mg
剂型Capsule, hard
上市许可持有人Glenmark Arzneimittel GmbH Industriestrasse 31 82194 Groebenzell Bavaria, Germany
参考成员国 - 产品名称Denmark (DK)
Fingolimod Glenmark
互认成员国 - 产品名称
    • Sweden (SE)
    • Poland (PL)
    • Czechia (CZ)
      Fingolimod Glenmark
    • Slovakia (SK)
      Fingolimod Glenmark 0,5 mg
    • Germany (DE)
      Fingolimod Glenmark 0,5 mg Hartkapseln
    • Netherlands (NL)
    • United Kingdom (Northern Ireland) (XI)
    • Spain (ES)
许可日期2021/01/20
最近更新日期2024/03/26
药物ATC编码
    • L04AE Sphingosine 1-phosphate (S1P) receptor modulators
申请类型
  • TypeLevel1:Known Active Substance
  • 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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