欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号NL/H/5845/001
药品名称Mellozzan 1 mg, tablet
活性成分
    • Melatonin 1.0 mg
剂型Tablet
上市许可持有人H.A.C. Pharma Pericentre 2 43 Avenue De La Cote De Nacre 14000 Caen France
参考成员国 - 产品名称Netherlands (NL)
Mellozzan 1 mg, tablet
互认成员国 - 产品名称
    • France (FR)
许可日期2024/11/12
最近更新日期2024/11/21
药物ATC编码
    • N05CH01 melatonin
申请类型
  • TypeLevel1：Known Active Substance
  • TypeLevel2：Initial Application
  • TypeLevel3：Bibliographic Art 10 a 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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