Is Lapatinib 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 Lapatinib, including Ortyka (250 mg, Film-coated tablet, SAR 3149.80); TYKERB 250MG F.C. TABLETS (250 mg, Film-coated tablet, SAR 3374.80).

Is Lapatinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Lapatinib: Tyverb.

Are there safety signals or safety updates for Lapatinib?

EMA PRAC: 2 entries (latest 2018-04-12).

Active substance

Lapatinib

SFDA 4
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
Ortyka	250 mg	Film-coated tablet · Oral use	70 Blister	SAR 3149.80	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
TYKERB 250MG F.C. TABLETS	250 mg	Film-coated tablet · Oral use	70 Blister	SAR 3374.80	NCE · Prescription	NOVARTIS PHARMA AG	Valid
TYKERB 250MG F.C. TABLETS	250 mg	Film-coated tablet · Oral use	70 Blister	SAR 7375.05	NCE · Prescription	GLAXO	Withdrawn by MAH · Not Marketed
TYKERB 250MG F.C. TABLETS	250 mg	Film-coated tablet · Oral use	70 Blister	SAR 7375.05	NCE · Prescription	GLAXO SAUDI ARABIA	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

BRAIN CANCERS; BREAST CANCER MET.HER-2 +VE; COLORECTAL CANCER-ADVANCED/ METASTATIC

EMA European Union — centrally authorised medicines

Tyverb Novartis Europharm Limited · Authorised · authorised 10 Jun 2008 · ATC L01EH01

Therapeutic indication (EMA)

Tyverb is indicated for the treatment of patients with breast cancer, whose tumours overexpress HER2 (ErbB2): in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting; in combination with trastuzumab for patients with hormone-receptor-negative metastatic disease that has progressed on prior trastuzumab therapy or therapies in combination with chemotherapy; in combination with an aromatase inhibitor for post-menopausal women with hormone-receptor-positive metastatic disease, not currently intended for chemotherapy. The patients in the registration study had not previously been treated with trastuzumab or an aromatase inhibitor. No data are available on the efficacy of this combination relative to trastuzumab in combination with an aromatase inhibitor in this patient population.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
TYKERB	02326442	250 MG	TABLET · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC

Safety signals and safety-related labeling changes

EMA PRAC 12 Apr 2018 PRAC signal: Pulmonary hypertension
Action for MAH: update of the product information: Yes
EMA PRAC 30 Nov 2017 PRAC signal: Pulmonary hypertension
Action for MAH: update of the product information: No

All safety entries for lapatinib →

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.