TARCEVA

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

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 more about Erlotinib

Medication package inserts

Below package inserts are available for further reading:

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