OPDIVO

This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Spain, Turkey, UK.

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 more about Nivolumab

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
OPDIVO Concentrate for solution for infusion	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		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)
AU	Pharmaceutical Benefits Scheme	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
BR	Câmara de Regulação do Mercado de Medicamentos	505116070022601, 505116070022701
CA	Health Products and Food Branch	02446626, 02446634
EE	Ravimiamet	1691748, 1691759, 1777765, 1882380
ES	Centro de información online de medicamentos de la AEMPS	1151014001, 1151014001IP, 1151014002, 1151014002IP
FI	Lääkealan turvallisuus- ja kehittämiskeskus	046743, 127030, 451960, 558826
FR	Base de données publique des médicaments	66367812
GB	Medicines & Healthcare Products Regulatory Agency	298877, 298879, 355417, 368186, 392464, 392466
HK	Department of Health Drug Office	64231, 64232
IL	מִשְׂרַד הַבְּרִיאוּת	7622, 7623
IT	Agenzia del Farmaco	044291019, 044291021, 044291033, 044291045, 049708011, 050524014
JP	医薬品医療機器総合機構	4291427A1024, 4291427A2020, 4291427A3027, 4291427A4023
LT	Valstybinė vaistų kontrolės tarnyba	1077355, 1077356, 1085955
NL	Z-Index G-Standaard, PRK	126675, 126683, 151149
NZ	Medicines and Medical Devices Safety Authority	18082, 18083
PL	Rejestru Produktów Leczniczych	100343330
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W65560001, W65560002, W65560003, W65560004
SG	Health Sciences Authority	14975P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699726765007, 8699726765502
US	FDA, National Drug Code	0003-3734, 0003-3772, 0003-3774