欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号NL/H/5363/002
药品名称Retenar 50 mg, prolonged-release tablets
活性成分
    • Mirabegron 50.0 mg
剂型Prolonged-release tablet
上市许可持有人Sandoz B.V. Veluwezoom 22 1327 AH Almere The Netherlands
参考成员国 - 产品名称Netherlands (NL)
OFULMEYA 50 mg, tabletten met verlengde afgifte
互认成员国 - 产品名称
    • Bulgaria (BG)
      OFULMEYA
    • Czechia (CZ)
      Ofulmeya
    • Slovakia (SK)
许可日期2024/10/23
最近更新日期2024/12/18
药物ATC编码
    • G04BD12 mirabegron
申请类型
  • TypeLevel1：Known Active Substance
  • 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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