欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号NL/H/5490/001
药品名称Ovalute 100 mg Capsule, soft
活性成分
    • progesterone 100.0 mg
剂型Capsule, soft
上市许可持有人Theramex Ireland Ltd 3rd Floor, Kilmore House, Park Lane Spencer Dock DOI YE64 Dublin Ireland
参考成员国 - 产品名称Netherlands (NL)
Ovalute 100 mg Capsule, soft
互认成员国 - 产品名称
    • Belgium (BE)
    • France (FR)
    • Ireland (IE)
    • Spain (ES)
    • Germany (DE)
      Ovalute
许可日期2023/06/28
最近更新日期2023/07/03
药物ATC编码
    • G03DA04 progesterone
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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