欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号NL/H/3717/001
药品名称Irinotecan SUN 1.5 mg/ml solution for infusion
活性成分
    • irinotecan hydrochloride 1.5 mg/ml
剂型Solution for infusion
上市许可持有人Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87 2132 JH Hoofdorp The Netherlands
参考成员国 - 产品名称Netherlands (NL)
Irinotecan SUN, 1,5 mg/ml oplossing voor infusie
互认成员国 - 产品名称
    • Denmark (DK)
    • Finland (FI)
    • France (FR)
    • Germany (DE)
      Irinotecan SUN 1,5 mg/ml Infusionslösung
    • Italy (IT)
    • Norway (NO)
    • Spain (ES)
    • United Kingdom (GB)
    • Sweden (SE)
许可日期2017/04/24
最近更新日期2017/05/17
药物ATC编码
    • L01XX19 irinotecan
申请类型
  • TypeLevel1：Abridged
  • TypeLevel2：Initial Application
  • TypeLevel3：Other Generic application Art 10.3 Dir 2001/83/EC
  • TypeLevel4：Chemical Substance
  • TypeLevel5：Prescription Only
附件文件下载
    市场状态Withdrawn（注：已撤市）
    撤市原因：1.The company decided to withdraw the application. At the time of withdrawal, the MS considered that the data provided did not allow to conclude on a positive benefit-risk balance as major objections were raised.
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