Palivizumab

Therapeutic Palivizumab antibody from the original Synagis® commercial drug

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Product
Batch

Antigen
Molecular Class
Drug Brand
Product Concentration
CoA
Quantity per vial
Storage Temperature
Expiry Date
Price
Respiratory syncytial virus (RSV)
Monoclonal Antibody
Synagis®
100 mg/mL
yes
4 mg
-80°C
04/2019
477,00 
view product
Max: 10
Min: 1
Step: 1
Respiratory syncytial virus (RSV)
Monoclonal Antibody
Synagis®
100 mg/mL
yes
4 mg
-80°C
06/2019
477,00 
view product
Max: 10
Min: 1
Step: 1
Respiratory syncytial virus (RSV)
Monoclonal Antibody
Synagis®
100 mg/mL
yes
4 mg
-80°C
10/2019
477,00 
view product
Max: 10
Min: 1
Step: 1
Respiratory syncytial virus (RSV)
Monoclonal Antibody
Synagis®
100 mg/mL
yes
4 mg
-80°C
02/2020
477,00 
view product
Max: 10
Min: 1
Step: 1
Respiratory syncytial virus (RSV)
Monoclonal Antibody
Synagis®
100 mg/mL
yes
4 mg
-80°C
08/2020
477,00 
view product
Max: 10
Min: 1
Step: 1
Respiratory syncytial virus (RSV)
Monoclonal Antibody
Synagis®
100 mg/mL
4 mg
-80°C
03/2022
477,00 
view product
Max: 10
Min: 1
Step: 1

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Synagis®/ Palivizumab Reference Product

Drug nameSynagis®
INNPalivizumab
API typePalivizumab is a recombinant humanised monoclonal antibody produced by DNA technology in mouse myeloma host cells.
Pharmacotherapeutic group
Immune sera immunoglobulins, specific immunoglobulins
ATC code
J06BB16
Target of antibody
RSV protein F
General functionPalivizumab is a humanised IgG1 monoclonal antibody directed to an epitope in the A antigenic site of the fusion protein of respiratory syncytial virus (RSV). This humanised monoclonal antibody is composed of human (95%) and murine (5%) antibody sequences. It has potent neutralising and fusion-inhibitory activity against both RSV subtype A and B strains.
Short description
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
Palivizumab is a humanised IgG1κ monoclonal antibody directed to an epitope in the A antigenic site of the fusion protein of respiratory syncytial virus (RSV). This humanised monoclonal antibody is composed of human (95%) and murine (5%) antibody sequences. It has potent neutralising and fusion-inhibitory activity against both RSV subtype A and B strains.
Palivizumab serum concentrations of approximately 30 μg/ml have been shown to produce a 99% reduction in pulmonary RSV replication in the cotton rat model.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)Palivizumab binds a highly conserved region on the extracellular domain of mature RSV F protein, referred to as antigenic site II or A antigenic site, which encompasses amino acids 262 to 275. The antiviral activity of palivizumab was assessed in a microneutralization assay in which increasing concentrations of antibody were incubated with RSV prior to addition of the human epithelial cells HEp-2.
Original license holder
AstraZeneca AB
Marketing authorisation numbers
EU/1/99/117/001
Marketing authorisation holder
AstraZeneca AB
SE-151 85 Södertälje
Sweden
Name of the manufacturer of the biological active substance
Boehringer Ingelheim Pharma GmbH & Co. KG
D-88397 Biberach an der Riss
Germany

AstraZeneca Pharmaceuticals Limited Partnership (AZPLP)
660 MedImmune Court / 633 Research Court, Frederick, Maryland,
USA
Name and address of the manufacturer(s) responsible for batch releaseAbbVie S.r.l.
04011 Campoverde di Aprilia (LT)
Italy
Max shelf life
48 months
Storage conditions
2°C – 8°C
List of excipients
Powder:
Histidine
Glycine
Mannitol (E421)
Evidentic Support
+49 (0) 30 959 99 8831

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