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Drug

Momelotinib dihydrochloride monohydrate

Approved medicine
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Approval: Omjjara (EMA)

Regulatory2024-01-25EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Momelotinib dihydrochloride monohydrate
RxNorm CUI
2665205
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2024-01-25
Latest approval
2024-01-25
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2024-01-25Approval
Approval: Omjjara (EMA)
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, postShow full 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.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Regulatory event sources are credited in the Regulatory Timeline above.