欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号SE/H/1589/003
药品名称Quetiapine Amneal
活性成分
    • QUETIAPINE FUMARATE 200.0 mg
剂型Prolonged-release tablet
上市许可持有人Amneal Pharma Europe Limited
参考成员国 - 产品名称Sweden (SE)
互认成员国 - 产品名称
    • Germany (DE)
      Quetiapine Amneal 200 mg Retardtabletten
    • Denmark (DK)
    • Spain (ES)
    • Finland (FI)
    • France (FR)
    • Norway (NO)
    • United Kingdom (GB)
许可日期2016/10/27
最近更新日期2016/11/04
药物ATC编码
    • N05AH04 quetiapine
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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