欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号HU/H/0476/004
药品名称Erlotinib Sandoz
活性成分
    • Erlotinib 150.0 mg
剂型Film-coated tablet
上市许可持有人PharOS – Pharmaceutical Oriented Services Ltd Lesvou str. (end), Thesi Loggos, Industrial Zone Metamorfossi Attikis 144 52 Greece
参考成员国 - 产品名称Hungary (HU)
ERLOTINIB SANDOZ 150 mg filmtabletta
互认成员国 - 产品名称
    • Germany (DE)
      Berzin 150 mg Filmtabletten
    • Latvia (LV)
      Erlotinib Sandoz 150 mg apvalkotās tabletes
    • Bulgaria (BG)
      Berzin 150mg филмирани таблетки
    • Denmark (DK)
      Erlotinib Sandoz
    • Belgium (BE)
      Erlotinib Sandoz 150 mg filmomhulde tabletten
    • Netherlands (NL)
      Erlotinib Sandoz 150 mg, filmomhulde tabletten
    • United Kingdom (Northern Ireland) (XI)
    • France (FR)
    • Spain (ES)
    • Portugal (PT)
    • Czechia (CZ)
    • Italy (IT)
    • Sweden (SE)
    • Slovakia (SK)
许可日期2017/05/17
最近更新日期2025/09/26
药物ATC编码
    • L01XE03 erlotinib
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
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市场状态Positive
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