Is Deferiprone registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Deferiprone, including FERRIPROX 100MG/ML ORAL SOLUTION (100 mg/ml, Oral solution, SAR 547.35); FERRIPROX 500MG F.C.TABLET (500 mg, Film-coated tablet, SAR 526.35); Ferriprox (1000 mg, modified-release tablet, SAR 631.60); Olvia (500 mg, Film-coated tablet, SAR 368.45).

Is Deferiprone approved by the US FDA?

Drugs@FDA lists 8 application product lines for Deferiprone, including FERRIPROX (Prescription); FERRIPROX (Prescription); DEFERIPRONE (Prescription); FERRIPROX (Prescription); DEFERIPRONE (Prescription).

Is Deferiprone authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Deferiprone: Ferriprox, Deferiprone Lipomed.

Is Deferiprone on the WHO Model List of Essential Medicines?

Yes — 10.3. Medicines for haemoglobinopathies (core list): Therapeutic equivalent to deferasirox for Other specified sickle cell disorders or other haemoglobinopathies; Therapeutic equivalent to deferasirox for Thalassaemias.

Are there safety signals or safety updates for Deferiprone?

US FDA: 3 entries (latest 2025-03-26).

Active substance

Deferiprone

SFDA 4
US FDA 8
EMA 3
Health Canada 5
WHO EML 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
FERRIPROX 100MG/ML ORAL SOLUTION	100 mg/ml	Oral solution · Oral use	1 Bottle	SAR 547.35	NCE · Prescription	CHIESI FARMACEUTICIS	Valid
FERRIPROX 500MG F.C.TABLET	500 mg	Film-coated tablet · Oral use	100 Blister	SAR 526.35	NCE · Prescription	CHIESI FARMACEUTICIS	Valid
Ferriprox	1000 mg	modified-release tablet · Oral use	50 Blister	SAR 631.60	NCE · Prescription	CHIESI FARMACEUTICIS	Valid
Olvia	500 mg	Film-coated tablet · Oral use	100 Blister	SAR 368.45	Generic · Prescription	GENEPHARM S.A.	Valid

Indications — CHI Daman Drug Formulary

HEMOCHROMATOSIS; SICKLE CELL DISEASE - IRON OVERLOAD MANAGEMENT; THALASSEMIA

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

Product	Strength	Form · route	Applicant	Status	First approved
FERRIPROX	1GM	tablet · oral	CHIESI	Prescription	14 Oct 2011
FERRIPROX	100MG/ML	solution · oral	CHIESI	Prescription	9 Sep 2015
DEFERIPRONE	500MG; 1GM	tablet · oral	TARO	Prescription	8 Feb 2019
FERRIPROX	1GM	tablet · oral	CHIESI	Prescription	19 May 2020
DEFERIPRONE	500MG; 1GM	tablet · oral	HIKMA PHARMS	Prescription	29 Mar 2021
DEFERIPRONE	500MG; 1GM	tablet · oral	SENORES PHARMS	Prescription	11 Dec 2025
FERRIPROX	500MG	tablet · oral	CHIESI	Discontinued	14 Oct 2011
FERRIPROX	80MG/ML	solution · oral	CHIESI	Discontinued	9 Sep 2015

EMA European Union — centrally authorised medicines

Ferriprox Chiesi Farmaceutici S.p.A. · Authorised · authorised 25 Aug 1999 · ATC V03AC02

Therapeutic indication (EMA)

Ferriprox monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate. Ferriprox in combination with another chelator is indicated in patients with thalassaemia major when monotherapy with any iron chelator is ineffective, or when prevention or treatment of life-threatening consequences of iron overload (mainly cardiac overload) justifies rapid or intensive correction.

Deferiprone Lipomed Lipomed GmbH · Authorised · authorised 19 Sep 2018 · ATC V03AC02

Therapeutic indication (EMA)

Deferiprone Lipomed monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate. Deferiprone Lipomed in combination with another chelator is indicated in patients with thalassaemia major when monotherapy with any iron chelator is ineffective, or when prevention or treatment of life-threatening consequences of iron overload justifies rapid or intensive correction.

Upkanz Apotex B.V. · Application withdrawn · ATC V03AC02

Therapeutic indication (EMA)

Treatment of neurodegeneration with brain iron accumulation.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
FERRIPROX	02436523	100 MG / ML	SOLUTION · ORAL	CHIESI CANADA CORP.
FERRIPROX	02436531	500 MG	TABLET · ORAL	CHIESI CANADA CORP.
FERRIPROX	02436558	1000 MG	TABLET · ORAL	CHIESI CANADA CORP.
FERRIPROX MR	02536579	1000 MG	TABLET (EXTENDED-RELEASE) · ORAL	CHIESI CANADA CORP.
TARO-DEFERIPRONE	02553112	1000 MG	TABLET · ORAL	TARO PHARMACEUTICALS INC

WHO WHO Model List of Essential Medicines (2025)

10.3. Medicines for haemoglobinopathies · core
Therapeutic equivalent to deferasirox for Other specified sickle cell disorders or other haemoglobinopathies; Therapeutic equivalent to deferasirox for Thalassaemias

Safety signals and safety-related labeling changes

US FDA 26 Mar 2025 FERRIPROX — 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 26 Mar 2025 FERRIPROX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 26 Mar 2025 FERRIPROX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for deferiprone →

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.