BEYFORTUS

This brand name is authorized in Austria, Canada, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Romania, United States

Active ingredients

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

1 Nirsevimab
UNII VRN8S9CW5V - NIRSEVIMAB

Nirsevimab is a recombinant neutralising human IgG1ĸ long-acting monoclonal antibody to the prefusion conformation of the RSV F protein which has been modified with a triple amino acid substitution (YTE) in the Fc region to extend serum half-life. Nirsevimab inhibits the essential membrane fusion step in the viral entry process, neutralising the virus and blocking cell-to-cell fusion.

Read about Nirsevimab

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
BEYFORTUS Solution for injection 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
J06BD08 J Antiinfectives for systemic use → J06 Immune sera and immunoglobulins → J06B Immunoglobulins → J06BD Antiviral monoclonal antibodies
Discover more medicines within J06BD08

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): 02537206, 02537214
Country: EE Ravimiamet Identifier(s): 1893405, 1893427, 1893438, 1893449
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 1221689001, 1221689004
Country: FR Base de données publique des médicaments Identifier(s): 62438151, 65150617
Country: IT Agenzia del Farmaco Identifier(s): 050403017, 050403029, 050403031, 050403043, 050403056, 050403068
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1095796, 1095797, 1095798, 1095799, 1095800, 1095801
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W69258001, W69258002, W69258003, W69259001, W69259002, W69259003
Country: US FDA, National Drug Code Identifier(s): 49281-574, 49281-575

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