Is Ponatinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Ponatinib, including ICLUSIG (15 mg, Film-coated tablet, SAR 9126.05); ICLUSIG (45 mg, Film-coated tablet, SAR 18252.15).

Is Ponatinib approved by the US FDA?

Drugs@FDA lists 2 application product lines for Ponatinib, including ICLUSIG (Prescription); PONATINIB HYDROCHLORIDE (Discontinued).

Is Ponatinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Ponatinib: Iclusig.

Are there safety signals or safety updates for Ponatinib?

EMA PRAC: 7 entries; US FDA: 1 entry; MHRA: 3 entries (latest 2026-04-10).

Active substance

Ponatinib

SFDA 2
US FDA 2
EMA 1
Health Canada 1
Safety 11

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ICLUSIG	15 mg	Film-coated tablet · Oral use	30 Bottle	SAR 9126.05	NCE · Prescription	TAKEDA PHARMACEUTICALS USA, INC.	Valid
ICLUSIG	45 mg	Film-coated tablet · Oral use	30 Bottle	SAR 18252.15	NCE · Prescription	TAKEDA PHARMACEUTICALS USA, INC.	Valid

Indications — CHI Daman Drug Formulary

ADULT ACUTE LYMPHOCYTIC LEUKEMIA (ALL); CHRONIC MYELOID LEUKAEMIA (CML)

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

Product	Strength	Form · route	Applicant	Status	First approved
ICLUSIG	EQ 15MG BASE; EQ 45MG BASE; EQ 30MG BASE; EQ 10MG BASE	tablet · oral	TAKEDA PHARMS USA	Prescription	14 Dec 2012
PONATINIB HYDROCHLORIDE	EQ 15MG BASE; EQ 45MG BASE	tablet · oral	APOTEX	Discontinued	14 Jul 2023

EMA European Union — centrally authorised medicines

Iclusig Incyte Biosciences Distribution B.V. · Authorised · authorised 1 Jul 2013 · ATC L01EA05

Therapeutic indication (EMA)

Iclusig is indicated as monotherapy in adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. Iclusig is indicated in combination with reduced-intensity chemotherapy in adult patients with newly diagnosed Ph+ ALL (see section 5.1). Iclusig is indicated as monotherapy in paediatric patients 6 years of age or older with chronic phase chronic myeloid leukaemia (CP-CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. See sections 4.2 for the assessment of cardiovascular status prior to start of therapy and 4.4 for situations where an alternative treatment may be considered.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ICLUSIG	02437333	15 MG	TABLET · ORAL	TAKEDA PHARMACEUTICALS U.S.A., INC.

Safety signals and safety-related labeling changes

EMA PRAC 10 Apr 2026 PRAC signal: Congenital megacolon, maternal exposure during pregnancy
Action for MAH: update of the product information: Yes
EMA PRAC 27 Nov 2025 PRAC signal: Congenital megacolon, maternal exposure during pregnancy
Action for MAH: update of the product information: No
US FDA 10 Oct 2025 ICLUSIG — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 2 Sep 2021 PRAC signal: Panniculitis
Action for MAH: update of the product information: Yes
EMA PRAC 6 May 2021 PRAC signal: Panniculitis
Action for MAH: update of the product information: No
EMA PRAC 11 Jul 2019 PRAC signal: Artery dissections and aneurysms
Action for MAH: update of the product information: Yes
EMA PRAC 16 May 2019 PRAC signal: Artery dissections and aneurysms
Action for MAH: update of the product information: No
EMA PRAC 29 Nov 2018 PRAC signal: Artery dissections and aneurysms
Action for MAH: update of the product information: No
MHRA 11 Oct 2018 Ponatinib (Iclusig▼): reports of posterior reversible encephalopathy syndrome
Interrupt treatment if posterior reversible encephalopathy syndrome (PRES) is confirmed and resume treatment only once the event is resolved and the benefit of continued treatment outweighs the risk of PRES.
MHRA 24 Apr 2017 Ponatinib (Iclusig▼): risk of vascular occlusive events—updated advice on possible dose reduction
Prescribers should consider reducing the dose of ponatinib to 15 mg a day for patients with chronic phase chronic myeloid leukaemia (CP-CML) who have achieved a major cytogenetic response.
MHRA 11 Dec 2014 Ponatinib (Iclusig▼): risk of vascular occlusive events
Available evidence shows that the risk of blood vessel blockage with ponatinib is likely to be dose-dependent, however the data are insufficient to recommend reducing the ponatinib dose.

All safety entries for ponatinib →

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.