欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号SE/H/2619/001
药品名称Slinda Plus
活性成分
    • Drospirenone 4.0 mg
    • Drospirenone 2.8 mg
剂型Film-coated tablet
上市许可持有人Exeltis Healthcare S.L., Spain
参考成员国 - 产品名称Sweden (SE)
互认成员国 - 产品名称
    • Italy (IT)
许可日期2025/11/21
最近更新日期2025/11/21
药物ATC编码
    • G03AC10 drospirenone
申请类型
  • TypeLevel1:Known Active Substance
  • TypeLevel2:Initial Application
  • TypeLevel3:Full Dossier
  • 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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