欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号NL/H/3512/001
药品名称Dapratis
活性成分
    • acetylsalicylic acid 100.0 mg
    • atorvastatin calcium trihydrate 20.0 mg
    • PERINDOPRIL ARGININE 5.0 mg
剂型Capsule, hard
上市许可持有人Les Laboratoires Servier 50 rue Carnot 92284 Suresnes Cedex France
参考成员国 - 产品名称Netherlands (NL)
互认成员国 - 产品名称
    • Bulgaria (BG)
      ASAPRILOR 20 mg/5 mg/100 mg
    • Czechia (CZ)
      DAPRATIS 20mg/5mg/100mg tvrdá tobolka
    • Greece (GR)
      DAPRATIS
    • Hungary (HU)
    • Italy (IT)
    • Lithuania (LT)
      ASAPRILOR 20mg/5mg/100mg kietosios kapsulės
    • Latvia (LV)
    • Portugal (PT)
    • Romania (RO)
许可日期2017/10/03
最近更新日期2018/02/22
药物ATC编码
    • C10BX Lipid modifying agents in combination with other drugs
申请类型
  • TypeLevel1:Known Active Substance
  • TypeLevel2:Multiple (Copy) Application
  • TypeLevel3:Full Dossier Art 8.3(i) 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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