Is Ibrutinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 10 valid registrations of Ibrutinib, including Dullarma (140 mg, Capsule, hard, SAR 24785.00); IMBRUVICA (140 mg, Film-coated tablet, SAR 8010.00); IMBRUVICA (420 mg, Film-coated tablet, SAR 24030.00); IMBRUVICA 140 mg capsule (140 mg, Capsule, SAR 32040.00); Ibrutinib BOS (420 mg, Film-coated tablet, SAR 16821.00).

Is Ibrutinib approved by the US FDA?

Drugs@FDA lists 8 application product lines for Ibrutinib, including IMBRUVICA (Prescription); IMBRUVICA (Prescription); IMBRUVICA (Prescription); IMBRUVICA (Prescription); IMBRUVICA (Prescription).

Is Ibrutinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Ibrutinib: Imbruvica.

Is Ibrutinib on the WHO Model List of Essential Medicines?

Yes — 8.2.2. Targeted therapies (complementary list): Chronic lymphocytic leukaemia or small lymphocytic lymphoma.

Are there safety signals or safety updates for Ibrutinib?

EMA PRAC: 9 entries; US FDA: 3 entries; MHRA: 1 entry (latest 2025-10-21).

Active substance

Ibrutinib

SFDA 10
US FDA 8
EMA 1
Health Canada 2
WHO EML 1
Safety 13

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Dullarma	140 mg	Capsule, hard · Oral use	120 Bottle	SAR 24785.00	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
IMBRUVICA	140 mg	Film-coated tablet · Oral use	30 Blister	SAR 8010.00	NCE · Prescription	JANSSEN PHARMACEUTICA N.V	Valid
IMBRUVICA	420 mg	Film-coated tablet · Oral use	30 Blister	SAR 24030.00	NCE · Prescription	Janssen-Cilag International NV	Valid
IMBRUVICA 140 mg capsule	140 mg	Capsule · Oral use	120 Tablet Container	SAR 32040.00	NCE · Prescription	JANSSEN-CILAG	Valid
Ibrutinib BOS	420 mg	Film-coated tablet · Oral use	30 Blister	SAR 16821.00	Generic · Prescription	Boston Oncology Arabia	Valid
Ibrutinib BOS	140 mg	Film-coated tablet · Oral use	30 Blister	SAR 5607.00	Generic · Prescription	Boston Oncology Arabia	Valid
Ibrutinib BOS	560 mg	Film-coated tablet · Oral use	30 Blister	SAR 22428.00	Generic · Prescription	Boston Oncology Arabia	Valid
Ibrutinib BOS	280 mg	Film-coated tablet · Oral use	30 Blister	SAR 11214.00	Generic · Prescription	Boston Oncology Arabia	Valid
Ibrutinib amarox	140 mg	Capsule · Oral use	120 Blister	SAR 21988.25	Generic · Prescription	Saudi Amarox	Valid
Incell	140 mg	Capsule, hard · Oral use	120 Bottle	SAR 22427.35	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid

Indications — CHI Daman Drug Formulary

GRAFT VERSUS HOST DISEASE - CHRONIC; LYMPHOPLASMACYTIC LYMPHOMA; MANTLE CELL LYMPHOMA; MARGINAL ZONE LYMPHOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
IMBRUVICA	140MG; 70MG	capsule · oral	PHARMACYCLICS LLC	Prescription	13 Nov 2013
IMBRUVICA	140MG; 280MG; 420MG	tablet · oral	PHARMACYCLICS LLC	Prescription	16 Feb 2018
IMBRUVICA	70MG/ML	suspension · oral	PHARMACYCLICS LLC	Prescription	24 Aug 2022
IMBRUVICA	70MG; 140MG	capsule · oral	PHARMACYCLICS LLC	Prescription	24 Aug 2022
IMBRUVICA	140MG; 230MG; 420MG; 560MG	tablet · oral	PHARMACYCLICS LLC	Prescription	24 Aug 2022
IBRUTINIB	140MG	capsule · oral	HETERO LABS LTD V	Prescription	8 Sep 2026
IMBRUVICA	560MG	tablet · oral	PHARMACYCLICS LLC	Discontinued	16 Feb 2018
IBRUTINIB	70MG; 140MG	capsule · oral	ZYDUS LIFESCIENCES	Discontinued	31 Mar 2021

EMA European Union — centrally authorised medicines

Imbruvica Janssen-Cilag International NV · Authorised · authorised 21 Oct 2014 · ATC L01EL01

Therapeutic indication (EMA)

Imbruvica in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (IMBRUVICA + R-CHOP) alternating with R-DHAP (or R-DHAOx) without Imbruvica, followed by Imbruvica monotherapy, is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who would be eligible for autologous stem cell transplantation (ASCT).Imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory MCL.Imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1).Imbruvica as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.Imbruvica as a single agent is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. IMBRUVICA in combination with rituximab is indicated for the treatment of adult patients with WM.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
IMBRUVICA	02434407	140 MG	CAPSULE · ORAL	JANSSEN INC
IMBRUVICA	02540215	70 MG / ML	SUSPENSION · ORAL	JANSSEN INC

WHO WHO Model List of Essential Medicines (2025)

8.2.2. Targeted therapies · complementary
Chronic lymphocytic leukaemia or small lymphocytic lymphoma
Oral > Solid: 140 mg

Safety signals and safety-related labeling changes

US FDA 21 Oct 2025 IMBRUVICA — 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 21 Oct 2025 IMBRUVICA — 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 21 Oct 2025 IMBRUVICA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 10 Apr 2025 PRAC signal: Cough
Action for MAH: update of the product information: No
EMA PRAC 28 Oct 2021 PRAC signal: Sudden death/cardiac death with ibrutinib and concomitant angiotensin-converting enzyme (ACE) inhibitors from a clinical trial
Action for MAH: update of the product information: No
EMA PRAC 2 Sep 2021 PRAC signal: Sudden death/cardiac death with ibrutinib and concomitant angiotensin-converting enzyme (ACE) inhibitors from a clinical trial
Action for MAH: update of the product information: No
EMA PRAC 29 Oct 2020 PRAC signal: Hepatitis E
Action for MAH: update of the product information: Yes
EMA PRAC 9 Jul 2020 PRAC signal: Hepatitis E
Action for MAH: update of the product information: No
EMA PRAC 5 Sep 2019 PRAC signal: Ischaemic stroke
Action for MAH: update of the product information: Yes
EMA PRAC 5 Sep 2019 PRAC signal: Neutrophilic dermatoses
Action for MAH: update of the product information: No
EMA PRAC 11 Apr 2019 PRAC signal: Ischaemic stroke
Action for MAH: update of the product information: No
MHRA 15 Aug 2017 Ibrutinib (Imbruvica▼): reports of ventricular tachyarrhythmia; risk of hepatitis B reactivation and of opportunistic infections
Temporarily discontinue ibrutinib in patients who develop symptoms suggestive of ventricular arrhythmia and assess benefit-risk before restarting therapy. Establish hepatitis B virus status before initiating ibrutinib. Consider prophylaxis for patients who are at an increased risk of opportunistic infections.
EMA PRAC 8 Oct 2015 PRAC signal: Peripheral neuropathy
Action for MAH: update of the product information: No

All safety entries for ibrutinib →

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.