欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号DE/H/5989/003
药品名称Leponex 200 mg Tabletten
活性成分
    • clozapine 200.0 mg
剂型Tablet
上市许可持有人Mylan Healthcare GmbH Freundallee 9A D-30173 Hannover Germany
参考成员国 - 产品名称Germany (DE)
Leponex 200 mg Tabletten
互认成员国 - 产品名称
    • Belgium (BE)
    • Croatia (HR)
    • Czechia (CZ)
      Leponex
    • Finland (FI)
    • Greece (GR)
    • Hungary (HU)
    • Ireland (IE)
    • Luxembourg (LU)
    • Spain (ES)
    • United Kingdom (GB)
许可日期2020/03/18
最近更新日期2020/07/07
药物ATC编码
    • N05AH02 clozapine
申请类型
  • TypeLevel1:Abridged
  • TypeLevel2:Initial Application
  • TypeLevel3:Full Dossier Art 8.3(i) 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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