欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号NL/H/4126/001
药品名称Rosuvastatin/Ezetimibe Mylan 10 mg/10 mg, film-coated tablets
活性成分
    • ezetimibe 10.0 mg
    • rosuvastatin calcium 10.0 mg
剂型Film-coated tablet
上市许可持有人Mylan Healthcare B.V. Krijgsman 20 1186 DM Amstelveen Netherlands
参考成员国 - 产品名称Netherlands (NL)
Rosuvastatine/Ezetimibe Mylan Healthcare 10 mg/10 mg, filmomhulde tabletten
互认成员国 - 产品名称
    • Belgium (BE)
      Myrosor 10mg/10mg filmomhulde tabletten
    • Luxembourg (LU)
    • United Kingdom (Northern Ireland) (XI)
    • France (FR)
    • Portugal (PT)
    • Italy (IT)
    • Greece (GR)
    • Hungary (HU)
      ROZOR 10 mg/10 mg filmtabletta
    • Bulgaria (BG)
      Rozor
    • Cyprus (CY)
      ROZOR 10MG/10MG FC TABS
    • Romania (RO)
    • Slovakia (SK)
      ROZOR 10 mg/10 mg
    • Slovenia (SI)
    • Malta (MT)
许可日期2018/10/11
最近更新日期2024/07/08
药物ATC编码
    • C10BA06 rosuvastatin and ezetimibe
申请类型
  • TypeLevel1：Known Active Substance
  • TypeLevel2：Initial Application
  • TypeLevel3：Full Dossier Art 8.3(i) Dir 2001/83/EC
  • TypeLevel4：Chemical Substance
  • TypeLevel5：Prescription Only
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市场状态Positive
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