Prognia
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🇪🇺EU · EMAAuthorisedATC: L01EEOrphan MedicineConditional Approval

Ezmekly(mirdametinib)

Neurofibromatosis 1;Neurofibroma, Plexiform

Marketing Authorisation Holder: Merck Europe B.V.

EMA Authorisation: 17/07/2025

INN: mirdametinib

Indication

Ezmekly as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric and adult patients with neurofibromatosis type 1 (NF1) aged 2 years and above.

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.