Is Hydroxycarbamide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 5 valid registrations of Hydroxycarbamide, including CUREAML 500 mg Capsules (500 mg, Capsule, SAR 52.55); Cekea (200 mg, Capsule, hard, SAR 27.60); Cekea (500 mg, Capsule, hard, SAR 63.35); Hydroxyurea medac (500 mg, Capsule, hard, SAR 154.00); XROMI (100 mg/ml, Oral solution, SAR 1393.30).

Is Hydroxycarbamide authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Hydroxycarbamide: Siklos, Xromi.

Are there safety signals or safety updates for Hydroxycarbamide?

EMA PRAC: 3 entries (latest 2018-05-17).

Active substance

Hydroxycarbamide

SFDA 5
EMA 2
NHS prices 4
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
CUREAML 500 mg Capsules	500 mg	Capsule · Oral use	30 Blister	SAR 52.55	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Cekea	200 mg	Capsule, hard · Oral use	30 Blister	SAR 27.60	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Cekea	500 mg	Capsule, hard · Oral use	30 Blister	SAR 63.35	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Hydroxyurea medac	500 mg	Capsule, hard · Oral use	100 Blister	SAR 154.00	Generic · Prescription	medac Gesellschaft für klinische Spezialpräparate mbH	Valid
XROMI	100 mg/ml	Oral solution · Oral use	1 Bottle	SAR 1393.30	NCE · Prescription	Nova Laboratories Limited	Valid

Indications — CHI Daman Drug Formulary

ADULT ACUTE MYELOID LEUKAEMIA (AML); CHRONIC MYELOID LEUKAEMIA (CML); HEAD AND NECK CANCER; MYELOFIBROSIS-SYMPTOMATIC, LOW-RISK; POLYCYTHEMIA VERA; SICKLE CELL DISEASE; THALASSEMIA

EMA European Union — centrally authorised medicines

Siklos Theravia · Authorised · authorised 29 Jun 2007 · ATC L01XX05

Therapeutic indication (EMA)

Siklos is indicated for the prevention of recurrent painful vaso-occlusive crises including acute chest syndrome in paediatric and adult patients suffering from symptomatic sickle-cell syndrome.

Xromi Lipomed GmbH · Authorised · authorised 1 Jul 2019 · ATC L01XX05

Therapeutic indication (EMA)

Xromi is indicated for the prevention of vaso-occlusive complications of Sickle Cell Disease in patients over 9 months of age.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
NHS Drug Tariff	Hydroxycarbamide 100mg tablets	£100.00	60 tablet	1 Oct 2026
NHS Drug Tariff	Hydroxycarbamide 1g tablets	£500.00	30 tablet	1 Oct 2026
NHS Drug Tariff	Hydroxycarbamide 500mg capsules	£15.74	100 capsule	1 Oct 2026
NHS Drug Tariff	Hydroxycarbamide 500mg/5ml oral solution sugar free	£250.00	150 ml	1 Oct 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

EMA PRAC 17 May 2018 PRAC signal: Progressive multifocal leukoencephalopathy (PML)
Action for MAH: update of the product information: No
EMA PRAC 8 Feb 2018 PRAC signal: Cutaneous lupus erythematosus
Action for MAH: update of the product information: Yes
EMA PRAC 1 Sep 2017 PRAC signal: Cutaneous lupus erythematosus
Action for MAH: update of the product information: No

All safety entries for hydroxycarbamide →

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.