Is Momelotinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Momelotinib, including Ojjaara (100 mg, Film-coated tablet, SAR 22816.70); Ojjaara (150 mg, Film-coated tablet, SAR 22816.70); Ojjaara (200 mg, Film-coated tablet, SAR 22816.70).

Is Momelotinib approved by the US FDA?

Drugs@FDA lists 1 application product line for Momelotinib, including OJJAARA (Prescription).

Is Momelotinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Momelotinib: Omjjara.

Are there safety signals or safety updates for Momelotinib?

US FDA: 1 entry (latest 2026-07-20).

Active substance

Momelotinib

SFDA 3
US FDA 1
EMA 1
Health Canada 3
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Ojjaara	100 mg	Film-coated tablet · Oral use	30 Bottle	SAR 22816.70	NCE · Prescription	Glaxo Saudi Arabia Ltd.	Valid
Ojjaara	150 mg	Film-coated tablet · Oral use	30 Bottle	SAR 22816.70	NCE · Prescription	Glaxo Saudi Arabia Ltd.	Valid
Ojjaara	200 mg	Film-coated tablet · Oral use	30 Bottle	SAR 22816.70	NCE · Prescription	Glaxo Saudi Arabia Ltd.	Valid

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
OJJAARA	EQ 100MG BASE; EQ 150MG BASE; EQ 200MG BASE	tablet · oral	GLAXOSMITHKLINE	Prescription	15 Sep 2023

EMA European Union — centrally authorised medicines

Omjjara GlaxoSmithKline Trading Services Limited · Authorised · authorised 25 Jan 2024

Therapeutic indication (EMA)

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.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
OJJAARA	02552965	100 MG	TABLET · ORAL	GLAXOSMITHKLINE INC
OJJAARA	02552973	150 MG	TABLET · ORAL	GLAXOSMITHKLINE INC
OJJAARA	02552981	200 MG	TABLET · ORAL	GLAXOSMITHKLINE INC

Safety signals and safety-related labeling changes

US FDA 20 Jul 2026 OJJAARA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for momelotinib →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.