Is Ruxolitinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 8 valid registrations of Ruxolitinib, including CELEZON (25 mg, Tablet, SAR 14033.70); CELEZON (20 mg, Tablet, SAR 11226.95); CELEZON (5 mg, Tablet, SAR 5490.75); CELEZON (15 mg, Tablet, SAR 11226.95); Celezon (10 mg, Tablet, SAR 9004.85).

Is Ruxolitinib approved by the US FDA?

Drugs@FDA lists 3 application product lines for Ruxolitinib, including JAKAFI (Prescription); OPZELURA (Prescription); JAKAFI XR (Prescription).

Is Ruxolitinib authorised in the European Union?

EMA lists 3 centrally authorised medicines containing Ruxolitinib: Jakavi, Opzelura, Ruxolitinib Viatris.

Are there safety signals or safety updates for Ruxolitinib?

US FDA: 3 entries (latest 2026-07-20).

Active substance

Ruxolitinib

SFDA 11
US FDA 3
EMA 4
Health Canada 5
US price lines 1
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
CELEZON	25 mg	Tablet · Oral use	60 Blister	SAR 14033.70	NCE · Prescription	Branch of jazeera pharmaceutical industries company	Valid
CELEZON	20 mg	Tablet · Oral use	56 Blister	SAR 11226.95	Generic · Prescription	Branch of jazeera pharmaceutical industries company	Valid
CELEZON	5 mg	Tablet · Oral use	56 Blister	SAR 5490.75	Generic · Prescription	Branch of jazeera pharmaceutical industries company	Valid
CELEZON	15 mg	Tablet · Oral use	56 Blister	SAR 11226.95	Generic · Prescription	Branch of jazeera pharmaceutical industries company	Valid
Celezon	10 mg	Tablet · Oral use	56 Blister	SAR 9004.85	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
JAKAVI 15MG TABLET	15 mg	Tablet · Oral use	56 Bottle	SAR 13769.30	NCE · Prescription	NOVARTIS PHARMA SCHWEIZ AG	Valid
JAKAVI 20MG TABLET	20 mg	Tablet · Oral use	56 Bottle	SAR 13080.85	NCE · Prescription	NOVARTIS PHARMA SCHWEIZ AG	Valid
JAKAVI 5MG TABLET	5 mg	Tablet · Oral use	56 Bottle	SAR 6977.80	NCE · Prescription	NOVARTIS PHARMA SCHWEIZ AG	Valid
JAKAVI 15MG TABLET	15 mg	Tablet · Oral use	56 Bottle	SAR 18866.05	NCE · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed
JAKAVI 20MG TABLET	20 mg	Tablet · Oral use	56 Bottle	SAR 18866.05	NCE · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed
JAKAVI 5MG TABLET	5 mg	Tablet · Oral use	56 Bottle	SAR 18866.05	NCE · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

GRAFT VERSUS HOST DISEASE; T-CELL LYMPHOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
JAKAFI	EQ 5MG BASE; EQ 10MG BASE; EQ 15MG BASE; EQ 20MG BASE; EQ 25MG BASE	tablet · oral	INCYTE CORP	Prescription	16 Nov 2011
OPZELURA	EQ 1.5% BASE	cream · topical	INCYTE CORP	Prescription	21 Sep 2021
JAKAFI XR	EQ 11MG BASE; EQ 22MG BASE; EQ 33MG BASE; EQ 44MG BASE; EQ 55MG BASE	tablet, extended release · oral	INCYTE CORP	Prescription	1 May 2026

EMA European Union — centrally authorised medicines

Jakavi Novartis Europharm Limited · Authorised · authorised 23 Aug 2012 · ATC L01EJ01

Therapeutic indication (EMA)

Myelofibrosis (MF)Jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.Polycythaemia vera (PV)Jakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.Graft versus host disease (GvHD)Acute GvHDJakavi is indicated for the treatment of adults and paediatric patients aged 28 days and older with acute graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1).Chronic GvHDJakavi is indicated for the treatment of adults and paediatric patients aged 6 months and older with chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1). Myelofibrosis (MF)Jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.Polycythaemia vera (PV)Jakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.Graft versus host disease (GvHD)Acute GvHDJakavi is indicated for the treatment of adults and paediatric patients aged 28 days and older with acute graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1).Chronic GvHDJakavi is indicated for the treatment of adults and paediatric patients aged 6 months and older with chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1).

Opzelura Incyte Biosciences Distribution B.V. · Authorised · authorised 19 Apr 2023 · ATC D11AH09

Therapeutic indication (EMA)

Vitiligo Opzelura is indicated for the treatment of non segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. Atopic dermatitis Opzelura is indicated for the treatment of moderate atopic dermatitis in adult patients for whom topical corticosteroids and topical calcineurin inhibitors are inadequate or inappropriate.

Ruxolitinib Viatris Viatris Limited · Authorised · authorised 18 Sep 2026 · ATC L01EJ01

Therapeutic indication (EMA)

Myelofibrosis (MF) Ruxolitinib Viatris is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. Polycythaemia vera (PV) Ruxolitinib Viatris is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea. Graft versus host disease (GvHD) Acute GvHD Ruxolitinib Viatris is indicated for the treatment of adults and paediatric patients aged 28 days and older with acute graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1). Chronic GvHD Ruxolitinib Viatris is indicated for the treatment of adults and paediatric patients aged 6 months and older with chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1).

Ruxolitinib Zentiva Zentiva k.s. · Opinion · ATC L01EJ01

Therapeutic indication (EMA)

Treatment of myelofibrosis (MF) in adults, treatment of polycythaemia vera (PV) in adults and treatment of Graft versus host disease (GvHD) in adults and children

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
JAKAVI	02388006	5 MG	TABLET · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
JAKAVI	02388014	15 MG	TABLET · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
JAKAVI	02388022	20 MG	TABLET · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
JAKAVI	02434814	10 MG	TABLET · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
OPZELURA	02552434	1.5 % / W/W	CREAM · TOPICAL	INCYTE CORPORATION

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	OPZELURA 1.5% CREAM	$34.01191	per GM	23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 20 Jul 2026 JAKAFI — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 20 Jul 2026 JAKAFI XR — safety-related labeling change
Labeling sections changed: Adverse Reactions
US FDA 30 Jun 2026 OPZELURA — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for ruxolitinib →

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.