Ezmekly (mirdametinib)
OrphanConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- mirdametinib
- Company
- Merck Europe B.V.
- Status
- Authorised
- Therapeutic area
- Neurofibromatosis 1; Neurofibroma, Plexiform
- CHMP opinion
- Thu 22 May 2025
- EU approval
- Thu 17 Jul 2025
- Designations
- Orphan, Conditional, Additional monitoring
- Application
- EMEA/H/C/006460
- ATC
- L01EE
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.