Is Ceritinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Ceritinib.

Is Ceritinib approved by the US FDA?

Drugs@FDA lists 2 application product lines for Ceritinib, including ZYKADIA (Prescription); ZYKADIA (Discontinued).

Is Ceritinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Ceritinib: Zykadia.

Are there safety signals or safety updates for Ceritinib?

US FDA: 2 entries (latest 2021-10-07).

Active substance

Ceritinib

SFDA 1
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
ZYKADIA 150 mg capsule	150 mg	Capsule, hard · Oral use	150 Blister	SAR 23120.45	NCE · Prescription	NOVARTIS PHARMA AG	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
ZYKADIA	150MG	tablet · oral	NOVARTIS	Prescription	18 Mar 2019
ZYKADIA	150MG	capsule · oral	NOVARTIS	Discontinued	29 Apr 2014

EMA European Union — centrally authorised medicines

Zykadia Novartis Europharm Limited · Authorised · authorised 6 May 2015 · ATC L01XE

Therapeutic indication (EMA)

Zykadia is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) previously treated with crizotinib.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ZYKADIA	02436779	150 MG	CAPSULE · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC

Safety signals and safety-related labeling changes

US FDA 7 Oct 2021 ZYKADIA — 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 7 Oct 2021 ZYKADIA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for ceritinib →

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.