Is Vandetanib 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 Vandetanib, including CAPRELSA 100 mg film-coated tablet (100 mg, Film-coated tablet, SAR 7149.00); CAPRELSA 300 mg film-coated tablet (300 mg, Film-coated tablet, SAR 19053.40).

Is Vandetanib approved by the US FDA?

Drugs@FDA lists 1 application product line for Vandetanib, including CAPRELSA (Prescription).

Is Vandetanib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Vandetanib: Caprelsa.

Are there safety signals or safety updates for Vandetanib?

EMA PRAC: 3 entries; US FDA: 1 entry (latest 2025-05-14).

Active substance

Vandetanib

SFDA 4
US FDA 1
EMA 2
Health Canada 2
Safety 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
CAPRELSA 100 mg film-coated tablet	100 mg	Film-coated tablet · Oral use	30 Blister	SAR 7149.00	NCE · Prescription	GENZYME EUROPE B.V.	Valid
CAPRELSA 300 mg film-coated tablet	300 mg	Film-coated tablet · Oral use	30 Blister	SAR 19053.40	NCE · Prescription	GENZYME EUROPE B.V.	Valid
CAPRELSA 100 mg film-coated tablet	100 mg	Film-coated tablet · Oral use	30 Blister	SAR 10028.10	NCE · Prescription	AstraZeneca	Withdrawn by MAH · Not Marketed
CAPRELSA 300 mg film-coated tablet	300 mg	Film-coated tablet · Oral use	30 Blister	SAR 20056.20	NCE · Prescription	AstraZeneca	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

THYROID CANCER-MEDULLARY CARCINOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
CAPRELSA	100MG; 300MG	tablet · oral	GENZYME CORP	Prescription	6 Apr 2011

EMA European Union — centrally authorised medicines

Caprelsa Esteve Pharmaceuticals, S.A. · Authorised · authorised 16 Feb 2012 · ATC L01XE

Therapeutic indication (EMA)

Caprelsa is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. Caprelsa is indicated in adults, children and adolescents aged 5 years and older. For patients in whom re-arranged-during-transfection(RET) mutation is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision.

Zactima AstraZeneca · Application withdrawn

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CAPRELSA	02378582	100 MG	TABLET · ORAL	SANOFI-AVENTIS CANADA INC
CAPRELSA	02378590	300 MG	TABLET · ORAL	SANOFI-AVENTIS CANADA INC

Safety signals and safety-related labeling changes

US FDA 14 May 2025 CAPRELSA — 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 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

All safety entries for vandetanib →

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.