Fertility warning
This medicine may affect fertility.
Medicine information EZMEKLY 1mg dispersible tablets
- Product code:
- W71877002
- Quantity:
- 84
- Indicated for:
- cancer
- Route of administration:
- oral
- Substance:
- mirdametinib (antineoplastic agent)
- ATC
- L01EE05 — 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.
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 1mg
- Substance:
- mirdametinib
- Date of latest medicines list:
- 01-10-2026
- Product code:
- W71877002
- Strength:
- 1mg
- Pharmaceutical form:
- dispersible tablets
- Quantity:
- 84
- Product type:
- Original
- Price:
- 59066.61 RON
- Prescription status:
- P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.
Pharmaceutical forms available for mirdametinib
Strengths available for mirdametinib
- 1mg
- 2mg
Official documents
The SmPC text is not displayed because a match to this medicine, strength and pharmaceutical form has not been confirmed.
- Added to database:
- 20/08/2025
- Source record updated:
- 02/09/2026
Warnings:
Dose adjustment in hepatic impairment
Dose adjustment may be needed in liver disease.
Cytotoxic / special handling
Handle with special care.
Contraception required
Effective contraception is required during treatment.
Contraindicated during breastfeeding
Do not use this medicine while breastfeeding.
Contraindicated during pregnancy
Do not use this medicine during pregnancy.
Hepatotoxicity
This medicine may affect the liver.
Major drug interactions
This medicine may have important interactions with other medicines.
Myelosuppression / agranulocytosis
This medicine may lower blood cell counts.
Additional monitoring
This medicine is subject to additional monitoring.
Requires periodic laboratory tests
Periodic laboratory tests may be required during treatment.
Severe skin reactions
Stop taking the medicine and seek urgent medical help if a severe rash occurs.