欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号NL/H/5610/001
药品名称Scleryda 120 mg, maagsapresistente harde capsules
活性成分
    • dimethyl fumarate 120.0 mg
剂型Gastro-resistant capsule, hard
上市许可持有人European Regulatory Affairs Limited (trading as Ivowen) 3 Anglesea Street, Clonmel, Co. Tipperary E91 D6C5, Ireland
参考成员国 - 产品名称Netherlands (NL)
Scleryda 120 mg, maagsapresistente harde capsules
互认成员国 - 产品名称
    • Italy (IT)
    • Greece (GR)
    • Cyprus (CY)
      Scleryda 120 mg γαστροανθεκτικά, σκληρά καψάκια
    • Malta (MT)
      Scleryda 120 mg Gastro-Resistant Hard
许可日期2023/10/25
最近更新日期2025/05/28
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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