Nivolumab

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
PD-1
Monoclonal Antibody
Opdivo®
10 mg/mL
2 mg
-80°C
08/2024
270,00 
view product
Max: 10
Min: 2
Step: 1
PD-1
Monoclonal Antibody
Opdivo®
10 mg/mL
2 mg
-80°C
08/2018
270,00 
view product
Max: 10
Min: 2
Step: 1
PD-1
Monoclonal Antibody
Opdivo®
10 mg/mL
2 mg
-80°C
10/2018
270,00 
view product
Max: 10
Min: 2
Step: 1
PD-1
Monoclonal Antibody
Opdivo®
10 mg/mL
2 mg
-80°C
02/2018
270,00 
view product
Max: 10
Min: 2
Step: 1
PD-1
Monoclonal Antibody
Opdivo®
10 mg/mL
2 mg
-80°C
05/2019
390,00 
view product
Max: 10
Min: 1
Step: 1
PD-1
Monoclonal Antibody
Opdivo®
10 mg/mL
2 mg
-80°C
01/2019
270,00 
view product
Max: 10
Min: 2
Step: 1
PD-1
Monoclonal Antibody
Opdivo®
10 mg/mL
2 mg
-80°C
09/2020
338,00 
view product
Max: 8
Min: 1
Step: 1
PD-1
Monoclonal Antibody
Opdivo®
10 mg/mL
2 mg
-80°C
11/2020
270,00 
view product
Max: 10
Min: 2
Step: 1
PD-1
Monoclonal Antibody
Opdivo®
10 mg/mL
2 mg
-80°C
02/2021
405,00 
view product
Max: 10
Min: 1
Step: 1
PD-1
Monoclonal Antibody
Opdivo®
10 mg/mL
2mg
-80°C
01/2024
675,00 
view product
Max: 1
Min: 1
Step: 1

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Opdivo® / Nivolumab Reference Product

Drug nameOpdivo®
INNNivolumab
API typeNivolumab 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 functionNivolumab, 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 releaseSwords 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)
Evidentic Support
+49 (0) 30 959 99 8831

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