欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号NL/H/3463/001
药品名称Voxitrina 20 mg/ml
活性成分
    • acetylcysteine 20.0 mg/ml
剂型Oral solution
上市许可持有人Actavis Group PTC ehf. Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland
参考成员国 - 产品名称Netherlands (NL)
Voxitrina 20 mg/ml
互认成员国 - 产品名称
    • Bulgaria (BG)
      Pinacetil
    • Denmark (DK)
    • Finland (FI)
    • Hungary (HU)
    • Iceland (IS)
    • Norway (NO)
    • Slovakia (SK)
      ACCEX 20 mg/ml
    • Sweden (SE)
许可日期2016/06/15
最近更新日期2017/08/03
药物ATC编码
    • R05CB01 acetylcysteine
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:Non Prescription (including OTC)
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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