This brand name is authorized in Austria, Canada, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States
The drug VIZIMPRO contains one active pharmaceutical ingredient (API):
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1
Dacomitinib monohydrate
UNII 5092U85G58 - DACOMITINIB
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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. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| VIZIMPRO Film-coated tablet | European Medicines Agency (EU) | MPI, EU: SmPC |
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 | |
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: FR | Base de données publique des médicaments | Identifier(s): 64582307, 65408925, 66311112 |
| 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: IT | Agenzia del Farmaco | Identifier(s): 047823012, 047823024, 047823036 |
| 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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