IRESSA

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

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 more about Gefitinib

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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