TARCEVA

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

Active ingredients

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

1 Erlotinib UNII DA87705X9K - ERLOTINIB HYDROCHLORIDE

Erlotinib is an epidermal growth factor receptor/human epidermal growth factor receptor type 1 (EGFR also known as HER1) tyrosine kinase inhibitor. Erlotinib potently inhibits the intracellular phosphorylation of EGFR. EGFR is expressed on the cell surface of normal cells and cancer cells. Due to the blocking of downstream-signaling, the proliferation of cells is stopped, and cell death is induced through the intrinsic apoptotic pathway. Read about Erlotinib

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
TARCEVA 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
L01EB02	Erlotinib	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 L01EB02

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 529208001115213, 529208002111211, 529208003118211
Country: CA	Health Products and Food Branch	Identifier(s): 02269007, 02269015, 02269023
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 28663-11-08, 28671-11-08
Country: EE	Ravimiamet	Identifier(s): 1218619, 1218620, 1218631
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 05311001, 05311002, 05311003
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 022045, 022191, 022205
Country: FR	Base de données publique des médicaments	Identifier(s): 61694240, 63390528, 67311535
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 115565, 95648, 95651
Country: HK	Department of Health Drug Office	Identifier(s): 54112, 54113, 54114, 57439, 57440, 57441
Country: IE	Health Products Regulatory Authority	Identifier(s): 88411, 88424, 88473
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 4935, 4936
Country: IT	Agenzia del Farmaco	Identifier(s): 036871010, 036871022, 036871034
Country: JP	医薬品医療機器総合機構	Identifier(s): 4291016F1020, 4291016F2027, 4291016F3023
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1031002, 1031003, 1031004
Country: MX	Comisión Federal para la Protección contra Riesgos Sanitarios	Identifier(s): 165M2006
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 79200, 79219, 79227
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 11882, 11883, 11884
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100140583, 100140590, 100140608
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W64407001, W64408001
Country: SG	Health Sciences Authority	Identifier(s): 13184P, 13185P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699505092003, 8699505092010, 8699505092027
Country: US	FDA, National Drug Code	Identifier(s): 50242-062, 50242-063, 50242-064
Country: ZA	Health Products Regulatory Authority	Identifier(s): A40/26/0359, A40/26/0360, A40/26/0361