OPDIVO

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, 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: IT	Agenzia del Farmaco	Identifier(s): 044291019, 044291021, 044291033, 044291045, 049708011, 050524014
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