Is Asciminib 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 Asciminib, including Scemblix (40 mg, Film-coated tablet, SAR 19832.70); Scemblix (20 mg, Film-coated tablet, SAR 19832.70).

Is Asciminib approved by the US FDA?

Drugs@FDA lists 1 application product line for Asciminib, including SCEMBLIX (Prescription).

Is Asciminib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Asciminib: Scemblix.

Are there safety signals or safety updates for Asciminib?

US FDA: 1 entry (latest 2026-09-22).

Active substance

Asciminib

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

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Scemblix	40 mg	Film-coated tablet · Oral use	60 Bottle	SAR 19832.70	NCE · Prescription	Novartis Europharm Limited	Valid
Scemblix	20 mg	Film-coated tablet · Oral use	60 Bottle	SAR 19832.70	NCE · Prescription	Novartis Europharm Limited	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
SCEMBLIX	EQ 20MG BASE; EQ 40MG BASE; EQ 100MG BASE	tablet · oral	NOVARTIS	Prescription	29 Oct 2021

EMA European Union — centrally authorised medicines

Scemblix Novartis Europharm Limited · Authorised · authorised 25 Aug 2022 · ATC L01EA06

Therapeutic indication (EMA)

Scemblix is indicated for the treatment of adult patients with Philadelphia chromosome positive chronic myeloid leukaemia in chronic phase (Ph+ CML CP). Scemblix is indicated for the treatment of adult patients with Ph+ CML-CP with the T315I mutation who are resistant to, intolerant to or ineligible for ponatinib (see section 5.1).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
SCEMBLIX	02528320	20 MG	TABLET · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
SCEMBLIX	02528339	40 MG	TABLET · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC

Safety signals and safety-related labeling changes

US FDA 22 Sep 2026 SCEMBLIX — 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 asciminib →

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.