VIZIMPRO

This brand name is authorized in Austria, Canada, Ecuador, Estonia, Spain, Finland, Hong Kong, Ireland, Japan, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States

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 about Dacomitinib

Medication package inserts

Below package inserts are available for further reading:

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

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