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EMA approval · 2026-01-28

EMA Authorised: Biktarvy (bictegravir;emtricitabine;tenofovir alafenamide;fumarate) — Gilead Sciences Ireland UC

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Summary

The EMA has authorized Biktarvy for HIV infections, with Gilead Sciences Ireland UC as the marketing authorization holder.

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Diseases / indications

Drugs mentioned

  • BIKTARVY (BICTEGRAVIR SODIUM, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE)

Snippet

Status: Authorised. Therapeutic area: HIV Infections. MAH: Gilead Sciences Ireland UC. Decision date: 12/12/2025