EMA Authorised: Symkevi (tezacaftor;ivacaftor) — Vertex Pharmaceuticals (Ireland) Limited

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Summary

The EMA authorised Symkevi (tezacaftor and ivacaftor) for cystic fibrosis. It has orphan medicine status.

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Diseases / indications

• Cystic Fibrosis

Drugs mentioned

• Symkevi (tezacaftor and ivacaftor)

Snippet

Status: Authorised. Therapeutic area: Cystic Fibrosis. MAH: Vertex Pharmaceuticals (Ireland) Limited. Decision date: 17/11/2025. Orphan medicine