EMA
approval
· 2025-10-30
EMA Authorised: Orkambi (Lumacaftor;ivacaftor) — Vertex Pharmaceuticals (Ireland) Limited
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
Snippet
Status: Authorised. Therapeutic area: Cystic Fibrosis. MAH: Vertex Pharmaceuticals (Ireland) Limited. Decision date: 30/10/2025