EZMEKLY 2mg capsules medication leaflet

L01EE05 mirdametinib • Antineoplastic and immunomodulating agents | Protein kinase inhibitors | Mitogen-activated protein kinase (MEK) inhibitors

Mirdametinib is a medicine used in people with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas that cannot be completely removed by surgery without major risk. It may be used in adults and children according to the specialist’s recommendation.

The medicine blocks MEK, a protein involved in cell growth signalling. By doing this, it may reduce tumour size or symptoms such as pain, limited movement or impaired function. The benefit is assessed through clinical examinations, symptom review and imaging tests.

Mirdametinib is taken by mouth according to a strict schedule, sometimes with planned treatment breaks. Taking the doses correctly is important. Before and during treatment, eye examinations, heart assessment and blood tests, including muscle enzyme tests, may be required.

Common side effects include rash, diarrhoea, nausea, vomiting, muscle or joint pain, tiredness, abdominal pain, headache and inflammation around the nails. Contact your doctor urgently if you develop blurred vision, eye pain, palpitations, breathing difficulty, swelling, severe muscle weakness or a widespread rash.

General data about EZMEKLY 2mg

Substance: mirdametinib

Date of last drug list: 01-04-2026

Commercial code: W71402001

Concentration: 2mg

Pharmaceutical form: capsules

Quantity: 42

Product type: original

Price: 59066.61 RON

Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

Manufacturer: MIAS PHARMA LIMITED - IRLANDA

Holder: SPRINGWORKS THERAPEUTICS IRELAND LIMITED - IRLANDA

Number: 1950/2025/04

Shelf life: 42 months

Pharmaceutical forms available for mirdametinib

Concentrations available for mirdametinib

1mg, 2mg

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