🇪🇺 MIRDAMETINIB in European Union

EMA authorised MIRDAMETINIB on 17 July 2025

Marketing authorisation

EMA — authorised 17 July 2025

  • Application: EMEA/H/C/006460
  • Marketing authorisation holder: Merck Europe B.V.
  • Local brand name: Ezmekly
  • 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.
  • Pathway: conditional, orphan
  • Status: approved

The European Medicines Agency (EMA) approved Ezmekly (MIRDAMETINIB) for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in patients with neurofibromatosis type 1 (NF1). This approval was granted on 17 July 2025. Ezmekly is indicated for patients aged 2 years and above, including both paediatric and adult patients. The marketing authorisation was granted through the conditional, orphan drug pathway.

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MIRDAMETINIB in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is MIRDAMETINIB approved in European Union?

Yes. EMA authorised it on 17 July 2025.

Who is the marketing authorisation holder for MIRDAMETINIB in European Union?

Merck Europe B.V. holds the EU marketing authorisation.