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EMA approval · 2026-08-13

EMA Authorised: Ezmekly (mirdametinib) — Merck Europe B.V.

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Summary

EU authority authorised Ezmekly (mirdametinib) for Neurofibromatosis type 1 with neurofibromas, including plexiform neurofibroma, under conditional and orphan d…

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Diseases / indications

Drugs mentioned

  • Ezmekly (mirdametinib)

Snippet

Status: Authorised. Therapeutic area: Neurofibromatosis 1;Neurofibroma, Plexiform. MAH: Merck Europe B.V.. Decision date: 12/08/2026. Conditional approval. Orphan medicine