欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号HU/H/0598/003
药品名称Rosamera 10 mg /10 mg /8 mg film-coated tablet
活性成分
    • Amlodipine 10.0 mg
    • Perindopril 8.0 mg
    • Rosuvastatin 10.0 mg
剂型Film-coated tablet
上市许可持有人KRKA, d.d., Novo mesto Šmarješka Cesta 6 Novo Mesto 8501 Slovenia Telephone +38516312155 Telefax +38673322742 E-mail martina.crevar@krka.biz
参考成员国 - 产品名称Hungary (HU)
ROXAMPEX 10 mg/10 mg/8 mg filmtabletta
互认成员国 - 产品名称
    • Portugal (PT)
    • Finland (FI)
    • Poland (PL)
      Rosamera
    • Latvia (LV)
      Roxampex 10 mg/10 mg/8 mg apvalkotās tabletes
    • Lithuania (LT)
      Roxampex 10 mg /10 mg /8 mg plėvele dengtos tabletės
    • Estonia (EE)
    • Bulgaria (BG)
      Rosamera
    • Romania (RO)
    • Slovakia (SK)
      Roxampex 10 mg/10 mg/8 mg filmom obalené tablety
    • Slovenia (SI)
      Roxampex 10 mg/10 mg/8 mg filmsko obložene tablete
许可日期2019/09/19
最近更新日期2025/01/13
药物ATC编码
    • C10BX Lipid modifying agents in combination with other drugs
申请类型
  • TypeLevel1:Known Active Substance
  • TypeLevel2:Initial Application
  • TypeLevel3:Fixed combination Art 10b Dir 2001/83/EC
  • TypeLevel4:Chemical Substance
  • TypeLevel5:Prescription Only
附件文件下载
市场状态Positive
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