Indications
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.
Composition
- Active substance
- Momelotinib dihydrochloride monohydrate
- International name (INN)
- momelotinib
Official product information
The European public assessment report holds the summary of product characteristics and the package leaflet in every EU language.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Medicine
- Omjjara
- Active substance
- Momelotinib dihydrochloride monohydrate
- Therapeutic area
- Splenomegaly, Myeloproliferative Disorders
- Marketing authorisation holder
- GlaxoSmithKline Trading Services Limited
- Status
- Authorised
- EU authorisation
- 25 Jan 2024
- EMA product number
- EMEA/H/C/005768
EMA designations
- Orphan medicine
- Yes
- Conditional approval
- No
- Biosimilar
- No
- Generic
- No
- Accelerated assessment
- No
- Additional monitoring
- Yes
- Patient safety information
- No