VIZIMPRO

This brand name is authorized in United States. It is also authorized in Austria, Canada, Croatia, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Spain, Turkey, UK.

Active ingredients

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

1	Dacomitinib monohydrate UNII 5092U85G58 - DACOMITINIB
	Dacomitinib is a pan-human epidermal growth factor receptor (HER) (EGFR/HER1, HER2, and HER4) inhibitor, with activity against mutated EGFR with deletions in exon 19 or the L858R substitution in exon 21. Dacomitinib binds selectively and irreversibly to its HER family targets thereby providing prolonged inhibition.
	Read more about Dacomitinib

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
VIZIMPRO 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
L01EB07		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 L01EB07

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
CA	Health Products and Food Branch	02486024, 02486032, 02486040
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	6098-MEE-0421, 6199-MEE-0421, 6268-MEE-0521
EE	Ravimiamet	1792470, 1792481, 1792504
ES	Centro de información online de medicamentos de la AEMPS	1191354001, 1191354002, 1191354003
FI	Lääkealan turvallisuus- ja kehittämiskeskus	444395, 526351, 559436
FR	Base de données publique des médicaments	64582307, 65408925, 66311112
GB	Medicines & Healthcare Products Regulatory Agency	372279, 372282, 372285
HK	Department of Health Drug Office	66413, 66414, 66415
IE	Health Products Regulatory Authority	88827, 88828, 88829
IT	Agenzia del Farmaco	047823012, 047823024, 047823036
JP	医薬品医療機器総合機構	4291056F1025, 4291056F2021
LT	Valstybinė vaistų kontrolės tarnyba	1087484, 1087485, 1087486
NL	Z-Index G-Standaard, PRK	197599, 197602, 197610
PL	Rejestru Produktów Leczniczych	100415979, 100415985, 100415991
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W66422001, W66423001, W66424001
TR	İlaç ve Tıbbi Cihaz Kurumu	8681308091130, 8681308091147, 8681308091154
US	FDA, National Drug Code	0069-0197, 0069-1198, 0069-2299, 63539-197