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EMA approval · 2023-09-27

EMA Authorised: Epclusa (sofosbuvir;velpatasvir) — Gilead Sciences Ireland UC

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Summary

EPAR entry indicating EMA authorised Epclusa (sofosbuvir/velpatasvir) for chronic hepatitis C, with Gilead as MAH and accelerated assessment.

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Diseases / indications

Drugs mentioned

  • Epclusa (sofosbuvir/velpatasvir)
  • Sofosbuvir/Velpatasvir (sofosbuvir/velpatasvir)

Snippet

Status: Authorised. Therapeutic area: Hepatitis C, Chronic. MAH: Gilead Sciences Ireland UC. Decision date: 07/08/2023. Accelerated assessment