欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号AT/H/0497/002
药品名称Bendamustine Accord 25 mg/ml concentrate for solution for infusion
活性成分
    • Bendamustine hydrochloride 25.0 mg/ml
剂型Concentrate for solution for infusion
上市许可持有人Accord Healthcare B.V. Winthontlaan 200 3526KV Utrecht Niederlande
参考成员国 - 产品名称Austria (AT)
互认成员国 - 产品名称
    • Slovenia (SI)
    • Denmark (DK)
    • Finland (FI)
    • Belgium (BE)
    • Poland (PL)
      Bendamustine Accord
    • United Kingdom (Northern Ireland) (XI)
    • Netherlands (NL)
    • Latvia (LV)
    • Iceland (IS)
      Bendamustine Accord 2,5 mg/ml Stofn fyrir innrennslisþykkni, lausn
    • Lithuania (LT)
      -
    • Ireland (IE)
    • Estonia (EE)
      Bendamustine Accord
    • France (FR)
    • Hungary (HU)
      Bendamustine Accord 25 mg/ml koncentrátum oldatos infúzióhoz
    • Spain (ES)
    • Bulgaria (BG)
    • Portugal (PT)
    • Cyprus (CY)
      Bendamustine Accord 25mg/ml concentrate for solution for Infusion
    • Italy (IT)
    • Czechia (CZ)
      BENDAMUSTINE ACCORD 25 MG/ML KONCENTRÁT PRO INFUZNÍ ROZTOK
    • Greece (GR)
      BENDAMUSTINE/ACCORD
    • Romania (RO)
      Bendamustina Accord 2,5 mg/ml pulbere pentru concentrat pentru solutie perfuzabila
    • Sweden (SE)
    • Slovakia (SK)
      Bendamustine Accord 2,5 mg/ml prášok na infúzny koncentrát
    • Germany (DE)
      Bendamustine Accord 25 mg/ml Konzentrat zur Herstellung einer Infusionslösung
    • Norway (NO)
      Bendamustine Accord
许可日期2022/01/26
最近更新日期2025/07/31
药物ATC编码
    • L01AA09 bendamustine
申请类型
  • TypeLevel1：Line Extension
  • TypeLevel2：Additional Strength/Form
  • TypeLevel3：Other Generic application Art 10.3 Dir 2001/83/EC
  • TypeLevel4：Chemical Substance
  • TypeLevel5：Prescription Only
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市场状态Positive
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