欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号AT/H/1177/001
药品名称Isovirum 1000 mg Tablets
活性成分
    • Inosine Acedoben Dimepranol 1000.0 mg
剂型Tablet
上市许可持有人Health-Med Sp. z o.o. sp.k. Ul. Walewska 8/5 04-022 Warsaw, Poland
参考成员国 - 产品名称Austria (AT)
互认成员国 - 产品名称
    • Portugal (PT)
    • Spain (ES)
许可日期2022/06/15
最近更新日期2022/06/15
药物ATC编码
    • J05AX05 inosine pranobex
申请类型
  • TypeLevel1：Abridged
  • TypeLevel2：Initial Application
  • TypeLevel3：Other Generic application Art 10.3 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.
    ©2006-2025 Drugfuture->European Union HMA Authorisation of Medicines DataBase