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EMA approval · 2025-10-30

EMA Authorised: Orkambi (Lumacaftor;ivacaftor) — Vertex Pharmaceuticals (Ireland) Limited

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Summary

The European Medicines Agency authorised Orkambi (lumacaftor/ivacaftor) for cystic fibrosis, with Vertex Pharmaceuticals (Ireland) Limited as the marketing auth…

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Diseases / indications

Drugs mentioned

  • ORKAMBI (lumacaftor and ivacaftor)

Snippet

Status: Authorised. Therapeutic area: Cystic Fibrosis. MAH: Vertex Pharmaceuticals (Ireland) Limited. Decision date: 30/10/2025