欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号NL/H/5068/002
药品名称Abiraterone acetate
活性成分
    • abiraterone acetate 500.0 mg
剂型Film-coated tablet
上市许可持有人Sandoz B.V.
参考成员国 - 产品名称Netherlands (NL)
Abirateron Sandoz 500 mg, filmomhulde tabletten
互认成员国 - 产品名称
    • Italy (IT)
    • Malta (MT)
      Abiraterone Sandoz 500mg film coated tablets
    • Czechia (CZ)
      Abiraterone Sandoz
    • Greece (GR)
    • Slovakia (SK)
      Abiraterón Sandoz 500 mgfilmom obalené tablety
    • Sweden (SE)
    • Croatia (HR)
      Abirateron Sandoz 500 mg filmom obložene tablete
    • Norway (NO)
      Abirateron Sandoz
    • United Kingdom (Northern Ireland) (XI)
    • Finland (FI)
    • Germany (DE)
      Abirateron Hexal 500 mg Filmtabletten
    • Poland (PL)
      Abiraterone Sandoz
    • Denmark (DK)
    • Latvia (LV)
      Abiraterone Sandoz 500 mg apvalkotās tabletes
    • Ireland (IE)
    • Lithuania (LT)
      Abiraterone Sandoz 500 mg plėvele dengtos tabletės pavadinimo
    • Austria (AT)
      Abirateron Sandoz 500 mg – Filmtabletten
    • Estonia (EE)
      ABIRATERONE SANDOZ
    • France (FR)
    • Hungary (HU)
    • Spain (ES)
    • Bulgaria (BG)
      Abirateron Sandoz
    • Portugal (PT)
    • Cyprus (CY)
      Abiraterone/Sandoz 500 mg επικαλυμμένα με λεπτό υμένιο δισκία
许可日期2021/04/21
最近更新日期2024/04/29
药物ATC编码
    • L02BX03 abiraterone
申请类型
  • TypeLevel1：Line Extension
  • 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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