欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号ES/H/0387/002
药品名称Darunavir Farma Job 800 mg film-coated tablets
活性成分
    • DARUNAVIR 800.0 mg
剂型Film-coated tablet
上市许可持有人Farma Job Registros Consult S.L. C/ Valle de Arán 6, Villanueva de la Cañada, 28692 Madrid, Spain
参考成员国 - 产品名称Spain (ES)
Darunavir Farma Job 800 mg comprimidos recubiertos con película EFG
互认成员国 - 产品名称
    • Malta (MT)
      Darunavir Farma Job 800 mg film-coated tablets
许可日期2017/05/09
最近更新日期2017/05/10
药物ATC编码
    • J05AE10 darunavir
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：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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