欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号NL/H/5851/002
药品名称Enzalutamide SDZ 80 mg, film-coated tablets
活性成分
    • enzalutamide 80.0 mg
剂型Film-coated tablet
上市许可持有人Sandoz B.V. Veluwezoom 22 Almere, 1327 AH Netherlands
参考成员国 - 产品名称Netherlands (NL)
Enzalutamide Sandoz 80 mg, filmomhulde tabletten
互认成员国 - 产品名称
    • Iceland (IS)
    • Latvia (LV)
    • Ireland (IE)
    • Lithuania (LT)
    • Austria (AT)
    • Hungary (HU)
      Enzalutamid 1 A Pharma 80 mg filmtabletta
    • France (FR)
    • Cyprus (CY)
      Enzalutamide Ebewe 80 mg επικαλυμμένα με λεπτό υμένιο δισκία
    • Spain (ES)
    • Czechia (CZ)
      Enzalutamid Sandoz s.r.o.
    • Portugal (PT)
    • Romania (RO)
      Enzalutamidă PharOS 80 mg comprimate filmate
    • Italy (IT)
    • Slovakia (SK)
    • Greece (GR)
    • Slovenia (SI)
    • Sweden (SE)
    • Malta (MT)
      Enzalutamide Ebewe 80 mg film-coated tablets
    • Norway (NO)
    • Croatia (HR)
    • Germany (DE)
      Enzalutamid HEXAL 80 mg Filmtabletten
    • Finland (FI)
    • Denmark (DK)
      Enzalutamide "Hexal"
    • Poland (PL)
      Enzalutamide Sandoz
许可日期2024/05/28
最近更新日期2025/09/17
药物ATC编码
    • L02BB04 enzalutamide
申请类型
  • TypeLevel1：Abridged
  • TypeLevel2：Additional Strength/Form
  • 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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