Is Acalabrutinib 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 Acalabrutinib, including Acalabrutinib BOS (100 mg, Capsule, hard, SAR 13972.05); Calquence (100 mg, Film-coated tablet, SAR 21385.85).

Is Acalabrutinib approved by the US FDA?

Drugs@FDA lists 2 application product lines for Acalabrutinib, including CALQUENCE (Prescription); CALQUENCE (Prescription).

Is Acalabrutinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Acalabrutinib: Calquence.

Are there safety signals or safety updates for Acalabrutinib?

US FDA: 2 entries (latest 2026-02-19).

Active substance

Acalabrutinib

SFDA 3
US FDA 2
EMA 1
Health Canada 1
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Acalabrutinib BOS	100 mg	Capsule, hard · Oral use	60 Blister	SAR 13972.05	Generic · Prescription	Boston Oncology Arabia	Valid
Calquence	100 mg	Film-coated tablet · Oral use	60 Blister	SAR 21385.85	NCE · Prescription	AstraZeneca UK Limited	Valid
Calquence	100 mg	Capsule, hard · Oral use	60 Blister	SAR 21385.85	NCE · Prescription	AstraZeneca UK Limited	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
CALQUENCE	100MG	capsule · oral	ASTRAZENECA	Prescription	31 Oct 2017
CALQUENCE	EQ 100MG BASE	tablet · oral	ASTRAZENECA	Prescription	3 Aug 2022

EMA European Union — centrally authorised medicines

Calquence AstraZeneca AB · Authorised · authorised 5 Nov 2020 · ATC L01EL02

Therapeutic indication (EMA)

Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).Calquence in combination with venetoclax with or without obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.Calquence in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant (ASCT).Calquence as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) not previously treated with a BTK inhibitor.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CALQUENCE	02535696	100 MG	TABLET · ORAL	ASTRAZENECA CANADA INC

Safety signals and safety-related labeling changes

US FDA 19 Feb 2026 CALQUENCE — 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 19 Feb 2026 CALQUENCE — 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

All safety entries for acalabrutinib →

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.