OPDIVO

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States

Active ingredients

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

1 Nivolumab
UNII 31YO63LBSN - NIVOLUMAB

Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody (HuMAb), which binds to the programmed death-1 (PD-1) receptor and blocks its interaction with PD-L1 and PD-L2. Nivolumab potentiates T-cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands. In syngeneic mouse models, blocking PD-1 activity resulted in decreased tumour growth.

Read about Nivolumab

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
OPDIVO Concentrate for solution for infusion 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
L01FF01 Nivolumab L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01F Monoclonal antibodies and antibody drug conjugates → L01FF PD-1/PDL-1 (Programmed cell death protein 1/death ligand 1) inhibitors
Discover more medicines within L01FF01

Authorization and marketing

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

Country Identification scheme Identifier(s)
Country: AU Pharmaceutical Benefits Scheme Identifier(s): 10745M, 10748Q, 10764M, 10775D, 11143L, 11150W, 11152Y, 11153B, 11157F, 11158G, 11159H, 11160J, 11411N, 11425H, 11434T, 11435W, 11532Y, 11543M, 11626X, 11627Y, 11636K, 11642R, 11900H, 11906P, 12303M, 12312B, 12315E, 12323N, 12574T, 12602G
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 505116070022601, 505116070022701
Country: CA Health Products and Food Branch Identifier(s): 02446626, 02446634
Country: EE Ravimiamet Identifier(s): 1691748, 1691759, 1777765, 1882380
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 1151014001, 1151014001IP, 1151014002, 1151014002IP
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 046743, 127030, 451960, 558826
Country: FR Base de données publique des médicaments Identifier(s): 66367812
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 298877, 298879, 355417, 368186, 392464, 392466
Country: HK Department of Health Drug Office Identifier(s): 64231, 64232
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 7622, 7623
Country: JP 医薬品医療機器総合機構 Identifier(s): 4291427A1024, 4291427A2020, 4291427A3027, 4291427A4023
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1077355, 1077356, 1085955
Country: NL Z-Index G-Standaard, PRK Identifier(s): 126675, 126683, 151149
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 18082, 18083
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100343330
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W65560001, W65560002, W65560003, W65560004
Country: SG Health Sciences Authority Identifier(s): 14975P
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8699726765007, 8699726765502
Country: US FDA, National Drug Code Identifier(s): 0003-3734, 0003-3772, 0003-3774

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