Is Gefitinib 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 Gefitinib, including IRESSA 250 mg film coated tablet (250 mg, Film-coated tablet, SAR 4437.65); Lunginib (250 mg, Film-coated tablet, SAR 4141.85).

Is Gefitinib approved by the US FDA?

Drugs@FDA lists 7 application product lines for Gefitinib, including IRESSA (Prescription); GEFITINIB (Prescription); GEFITINIB (Prescription); GEFITINIB (Prescription); IRESSA (Discontinued).

Is Gefitinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Gefitinib: Iressa.

Is Gefitinib on the WHO Model List of Essential Medicines?

Yes — 8.2.2. Targeted therapies (complementary list): Therapeutic equivalent to erlotinib for Other specified malignant neoplasms of bronchus or lung.

Are there safety signals or safety updates for Gefitinib?

EMA PRAC: 5 entries; US FDA: 1 entry (latest 2026-09-03).

Active substance

Gefitinib

SFDA 2
US FDA 7
EMA 2
Health Canada 3
WHO EML 1
Safety 6

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
IRESSA 250 mg film coated tablet	250 mg	Film-coated tablet · Oral use	30 Blister	SAR 4437.65	NCE · Prescription	AstraZeneca	Valid
Lunginib	250 mg	Film-coated tablet · Oral use	30 Blister	SAR 4141.85	Generic · Prescription	Eva Pharma for Pharmaceuticals & Medical Appliances	Valid

Indications — CHI Daman Drug Formulary

NON-SMALL-CELL LUNG CARCINOMA (NSCLC)

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

Product	Strength	Form · route	Applicant	Status	First approved
IRESSA	250MG	tablet · oral	ASTRAZENECA	Prescription	13 Jul 2015
GEFITINIB	250MG	tablet · oral	QILU PHARM HAINAN	Prescription	13 Feb 2023
GEFITINIB	250MG	tablet · oral	ACTAVIS LABS FL INC	Prescription	26 Apr 2023
GEFITINIB	250MG	tablet · oral	NATCO	Prescription	31 May 2023
IRESSA	250MG	tablet · oral	ASTRAZENECA	Discontinued	5 May 2003
GEFITINIB	250MG	tablet · oral	APOTEX	Discontinued	23 Sep 2022
GEFITINIB	250MG	tablet · oral	CIPLA	Discontinued	16 May 2025

EMA European Union — centrally authorised medicines

Iressa AstraZeneca AB · Authorised · authorised 24 Jun 2009 · ATC L01XE02

Therapeutic indication (EMA)

Iressa is indicated for the treatment of adult patients with locally advanced or metastatic non-small-cell lung cancer with activating mutations of epidermal-growth-factor-receptor tyrosine kinase.

Gefitinib Mylan Mylan Pharmaceuticals Limited · Withdrawn · authorised 27 Sep 2018 · ATC L01XE02

Therapeutic indication (EMA)

Gefitinib Mylan is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non small cell lung cancer (NSCLC) with activating mutations of EGFR TK.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-GEFITINIB	02468050	250 MG	TABLET · ORAL	APOTEX INC
IRESSA	02248676	250 MG	TABLET · ORAL	ASTRAZENECA CANADA INC
JAMP GEFITINIB	02500663	250 MG	TABLET · ORAL	JAMP PHARMA CORPORATION

WHO WHO Model List of Essential Medicines (2025)

8.2.2. Targeted therapies · complementary
Therapeutic equivalent to erlotinib for Other specified malignant neoplasms of bronchus or lung

Safety signals and safety-related labeling changes

EMA PRAC 3 Sep 2026 PRAC signal: Pulmonary alveolar haemorrhage
Action for MAH: update of the product information: No
US FDA 5 May 2021 IRESSA — safety-related labeling change
Labeling sections changed: Adverse Reactions
EMA PRAC 29 Sep 2017 PRAC signal: Recall phenomenon
Action for MAH: update of the product information: No
EMA PRAC 6 Apr 2017 PRAC signal: Recall phenomenon
Action for MAH: update of the product information: No
EMA PRAC 13 May 2016 PRAC signal: Pneumatosis intestinalis
Action for MAH: update of the product information: No
EMA PRAC 14 Jan 2016 PRAC signal: Pneumatosis intestinalis
Action for MAH: update of the product information: No

All safety entries for gefitinib →

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.