Dyslipidemias

• EMA approval · 2026-08-06
  EMA Authorised: Cholib (fenofibrate;simvastatin) — Viatris Healthcare Limited

  Cholib, a fixed-dose combination of fenofibrate and simvastatin, has been authorised for dyslipidemias in the European Union.

• EMA approval · 2026-03-13
  EMA Authorised: Vazkepa (Icosapent ethyl) — Recordati Industria Chimica e Farmaceutica S.p.A.

  EMA authorised Vazkepa (icosapent ethyl) for the treatment of dyslipidemias; the marketing authorization holder is Recordati Industria Chimi…

• EMA approval · 2026-03-04
  EMA Authorised: Leqvio (inclisiran) — Novartis Europharm Limited

  The European Medicines Agency authorised Leqvio (inclisiran) from Novartis Europharm Limited for hypercholesterolemia and dyslipidemias, wit…

• EMA approval · 2026-02-27
  EMA Authorised: Nilemdo (bempedoic acid) — Daiichi Sankyo Europe GmbH

  The European Medicines Agency authorised Nilemdo (bempedoic acid) for hypercholesterolemia and related dyslipidemias. The marketing authoris…

• EMA approval · 2026-02-27
  EMA Authorised: Nustendi (bempedoic acid;ezetimibe) — Daiichi Sankyo Europe GmbH

  The EMA has authorised Nustendi, a fixed-dose combination of bempedoic acid and ezetimibe, for hypercholesterolemia and related dyslipidemia…

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• EMA approval · 2025-12-16
  EMA Authorised: Cholib (fenofibrate;simvastatin) — Viatris Healthcare Limited

  The EMA has authorised Cholib, a fixed-dose combination of fenofibrate and simvastatin, for dyslipidemias.

• EMA approval · 2025-12-15
  EMA Authorised: Repatha (Evolocumab) — Amgen Europe B.V.

  EU regulators authorised Repatha (evolocumab) for dyslipidemias and hypercholesterolemia; decision date 12/12/2025.

• EMA approval · 2025-01-17
  EMA Authorised: Pravafenix (fenofibrate;pravastatin) — Laboratoires SMB S.A.

  The EMA authorised Pravafenix, a fixed-dose combination of fenofibrate and pravastatin, for dyslipidemias.