Nivolumab

Name: Nivolumab AAY2764
SKU: 08000241_AAY2764
Price: 316.00 EUR
Availability: InStock

Therapeutic Nivolumab antibody from the original Opdivo® commercial drug.

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Product Batch	Antigen	Molecular Class	Drug Brand	Product Concentration	CoA	Quantity per vial	Storage Temperature	Expiry Date	Price from
Nivolumab 8006657	PD-1	Monoclonal Antibody	Opdivo®	10 mg/mL	–	2 mg	-80°C	2024.08	316,00 €	view product Max: 10 Min: 1 Step: 1
Nivolumab 8038581	PD-1	Monoclonal Antibody	Opdivo®	10 mg/mL	–	2 mg	-80°C	2025.05	316,00 €	view product Max: 10 Min: 1 Step: 1
Nivolumab 8039750	PD-1	Monoclonal Antibody	Opdivo®	10 mg/mL	–	2 mg	-80°C	2025.03	316,00 €	view product Max: 10 Min: 1 Step: 1
Nivolumab AAN6970	PD-1	Monoclonal Antibody	Opdivo®	10 mg/mL	–	2 mg	-80°C	2018.08	316,00 €	view product Max: 10 Min: 1 Step: 1
Nivolumab AAP6351	PD-1	Monoclonal Antibody	Opdivo®	10 mg/mL	–	2 mg	-80°C	2018.10	316,00 €	view product Max: 10 Min: 1 Step: 1
Nivolumab AAQ3795	PD-1	Monoclonal Antibody	Opdivo®	10 mg/mL	–	2 mg	-80°C	2018.02	316,00 €	view product Max: 10 Min: 1 Step: 1
Nivolumab AAU3964	PD-1	Monoclonal Antibody	Opdivo®	10 mg/mL	–	2 mg	-80°C	2019.05	316,00 €	view product Max: 7 Min: 1 Step: 1
Nivolumab AAW0883	PD-1	Monoclonal Antibody	Opdivo®	10 mg/mL	–	2 mg	-80°C	2019.01	316,00 €	view product Max: 10 Min: 1 Step: 1
Nivolumab AAW6409	PD-1	Monoclonal Antibody	Opdivo®	10 mg/mL	–	2 mg	-80°C	2020.09	316,00 €	view product Max: 7 Min: 1 Step: 1
Nivolumab AAX0742	PD-1	Monoclonal Antibody	Opdivo®	10 mg/mL	–	2 mg	-80°C	2020.11	316,00 €	view product Max: 10 Min: 1 Step: 1
Nivolumab AAY2764	PD-1	Monoclonal Antibody	Opdivo®	10 mg/mL	–	2 mg	-80°C	2021.02	316,00 €	view product Max: 2 Min: 1 Step: 1

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Opdivo® / Nivolumab Reference Product

Drug name	Opdivo®
INN	Nivolumab
API type	Nivolumab is produced in Chinese hamster ovary cells by recombinant DNA technology
Pharmacotherapeutic group	Antineoplastic agents, monoclonal antibodies
ATC code	L01XC17
Target of antibody	PD-1; Synonyms: CD279, PD1, SLEB2, hPD-1, hPD-l, Ly101, Pdc1
General function	Nivolumab, is a monoclonal antibody, a type of protein that has been designed to attach to a receptor (target) called PD-1 found on cells of the immune system called T cells. Cancer cells can produce proteins (PD-L1 and PD-L2) that attach to this receptor and switch off the activity of the T cells, preventing them from attacking the cancer. By attaching to the receptor, nivolumab prevents PD-L1 and PD-L2 from switching off the T cells, thereby increasing the ability of the immune system to kill cancer cells.
Short description
Pharmacodynamic properties (Mechanism of action; Source EMA document)	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. The PD-1 receptor is a negative regulator of T-cell activity that has been shown to be involved in the control of T-cell immune responses. Engagement of PD-1 with the ligands PD-L1 and PD-L2, which are expressed in antigen-presenting cells and may be expressed by tumours or other cells in the tumour microenvironment, results in inhibition of T-cell proliferation and cytokine secretion. 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.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)	Nivolumab is an antineoplastic agent. Combined nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4) mediated inhibition results in improved anti-tumor responses in metastatic melanoma. In murine syngeneic tumor models, dual blockade of PD-1 and CTLA-4 resulted in synergistic anti-tumor activity.
Original license holder	Bristol-Myers Squibb Company USA
Marketing authorisation numbers	EU/1/15/1014/001 - 003
Marketing authorisation holder	Bristol-Myers Squibb Pharma EEIG Plaza 254 Blanchardstown Corporate Park 2 Dublin 15, D15 T867 Ireland
Name of the manufacturer of the biological active substance	Bristol-Myers Squibb Company 6000 Thompson Road East Syracuse, New York 13057 USA Swords Laboratories t/a Bristol-Myers Squibb Cruiserath Biologics Cruiserath Road, Mulhuddart Dublin 15, D15 H6EF Ireland
Name and address of the manufacturer(s) responsible for batch release	Swords Laboratories t/a Bristol-Myers Squibb Cruiserath Biologics Cruiserath Road, Mulhuddart Dublin 15, D15 H6EF Ireland
Max shelf life	36 months
Storage conditions	2°C – 8°C
List of excipients	Sodium citrate dihydrate Sodium chloride Mannitol (E421) Pentetic acid (diethylenetriaminepentaacetic acid) Polysorbate 80 (E433) Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)