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Omjjara ▼ momelotinib Support Materials

Resources for Healthcare Professionals

Dr Donal McLornan
SIMPLIFY-1 trial results

Omjjara (Momelotinib) | Abbreviated Prescribing Information

POM A. Marketing Authorisation Number: EU/1/20/1481/003. Further information available from GlaxoSmithKline, 12 Riverwalk, Citywest, Business Campus, Dublin 24. Tel: 01-4955000.

Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255 or via online form https://gsk.public.reportum.com/.

PM-IE-MML-WCNT-250006 | Date of Preparation: September 2025

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Summary of product characteristics & Patient information leaflet for 100 mg, 150 mg and 200 mg film coated tablets

INDICATION

OMJJARA is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.

Reference

  1. OMJJARA Summary of Product Characteristics (SPC), available on www.medicines.ie/medicines/omjjara-100-150-200-mg-film-coated-tablets-36329/spc. Last accessed: September 2024.

Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie.
Adverse events should also be reported to GlaxoSmithKline on 1800 244 255 or via online form https://gsk.public.reportum.com/.

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information.

Omjjara is a registered trademark of the GlaxoSmithKline group of companies.

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April 2025 | PM-IE-MML-WCNT-250003