欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号UK/H/5821/001
药品名称Paracetamol/Guaifenesin/Phenylephrine Hydrochloride Wrafton 250 mg/100 mg/5 mg Film Coated Tablets
活性成分
    • guaifenesin 100.0 mg
    • paracetamol 250.0 mg
    • phenylephrine hydrochloride 5.0 mg
剂型Film-coated tablet
上市许可持有人Janice King Wrafton, Braunton Devon EX33 2DL UK
参考成员国 - 产品名称United Kingdom (GB)
Paracetamol/Guaifenesin/Phenylephrine Hydrochloride Wrafton 250 mg/100 mg/5 mg Film Coated Tablets
互认成员国 - 产品名称
    • Poland (PL)
      Paracetamol+Guaifenesin+Phenylephrine Hydrochloride Wrafton
    • Spain (ES)
    • Germany (DE)
      Paracetamol/Guaifenesin/Phenylephrinhydrochlorid Wrafton 250 mg/100 mg/5 mg Filmtabletten
许可日期2015/11/20
最近更新日期2015/11/20
药物ATC编码
    • N02BE51 paracetamol, combinations excl. psycholeptics
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.
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