欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号SE/H/2112/001
药品名称Melatonin Zentiva
活性成分
    • Melatonin 2.0 mg
剂型Prolonged-release tablet
上市许可持有人Zentiva k.s., Czechia
参考成员国 - 产品名称Sweden (SE)
互认成员国 - 产品名称
    • France (FR)
    • United Kingdom (Northern Ireland) (XI)
    • Italy (IT)
许可日期2022/07/01
最近更新日期2022/07/04
药物ATC编码
    • N05CH01 melatonin
申请类型
  • TypeLevel1：Abridged
  • TypeLevel2：Initial Application
  • 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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