欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号NL/H/5723/001
药品名称Apremilast Sandoz 10 mg, 20 mg, 30 mg film-coated tablet
活性成分
    • Apremilast 10.0 mg
    • Apremilast 20.0 mg
    • Apremilast 30.0 mg
剂型Film-coated tablet
上市许可持有人Sandoz B.V. Hospitaaldreef 29 1315 RC Almere Netherlands
参考成员国 - 产品名称Netherlands (NL)
Apremilast Sandoz 10 mg, 20 mg, 30 mg filmomhulde tabletten
互认成员国 - 产品名称
    • Belgium (BE)
    • Ireland (IE)
    • France (FR)
    • Spain (ES)
    • Italy (IT)
    • Greece (GR)
    • Sweden (SE)
    • Finland (FI)
    • Hungary (HU)
    • Cyprus (CY)
      Apremilast/Sandoz 10 mg, 20 mg & 30 mg film-coated tablets
    • Germany (DE)
      Apremilast HEXAL 10 mg + 20 mg + 30 mg Filmtabletten
许可日期2024/04/17
最近更新日期2024/12/19
药物ATC编码
    • L04AA32 apremilast
申请类型
  • TypeLevel1:Abridged
  • TypeLevel2:Multiple (Copy) 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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