IRESSA

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States

Active ingredients

The drug IRESSA contains one active pharmaceutical ingredient (API):

1 Gefitinib UNII S65743JHBS - GEFITINIB

Gefitinib is a selective small molecule inhibitor of the epidermal growth factor receptor tyrosine kinase and is an effective treatment for patients with tumours with activating mutations of the EGFR tyrosine kinase domain regardless of line of therapy. No clinically relevant activity has been shown in patients with known EGFR mutation-negative tumours. Read about Gefitinib

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
IRESSA Film-coated tablets	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
L01EB01	Gefitinib	L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EB Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors
Discover more medicines within L01EB01

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 11264W, 8769M
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 502306301111313
Country: CA	Health Products and Food Branch	Identifier(s): 02248676
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 642-MEE-0115
Country: EE	Ravimiamet	Identifier(s): 1422616
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 09526001
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 010618
Country: FR	Base de données publique des médicaments	Identifier(s): 60457263
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 159786, 383729
Country: HK	Department of Health Drug Office	Identifier(s): 51753
Country: IE	Health Products Regulatory Authority	Identifier(s): 88524
Country: JP	医薬品医療機器総合機構	Identifier(s): 4291013F1027
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1050586, 1064024
Country: MX	Comisión Federal para la Protección contra Riesgos Sanitarios	Identifier(s): 458M2003
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 90778
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 10922
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100213106
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W54587001
Country: SG	Health Sciences Authority	Identifier(s): 12300P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 8233041H
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699786092792
Country: US	FDA, National Drug Code	Identifier(s): 0310-0482