Eculizumab

Therapeutic Eculizumab antibody from the original Soliris® commercial drug.

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Antigen
Molecular Class
Drug Brand
Product Concentration
CoA
Quantity per vial
Storage Temperature
Expiry Date
Price
C5 complement protein
Monoclonal Antibody
Soliris®
10 mg/mL
yes
4 mg
-80°C
04/2022
1.026,00 
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Soliris® / Eculizumab Reference Product

Drug nameSoliris®
INNEculizumab
API typeEculizumab is a humanised monoclonal (IgG2/4κ) antibody produced in NS0 cell line by recombinant DNA
technology.
Pharmacotherapeutic group
Selective immunosuppressants
ATC code
L04AA25
Target of antibody
C5 complement protein
General functionEculizumab is indicated in adults and children for the treatment of Paroxysmal nocturnal haemoglobinuria (PNH) and Atypical haemolytic uremic syndrome (aHUS).
Eculizumab is also indicated in adults for the treatment of Refractory generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR) antibody-positive, Neuromyelitis optica spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease.
Short description
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
Eculizumab is a terminal complement inhibitor that specifically binds to the complement protein C5 with high affinity, thereby inhibiting its cleavage to C5a and C5b and
preventing the generation of the terminal complement complex C5b-9. Eculizumab preserves the early components of complement activation that are essential for opsonization of microorganisms and clearance of immune complexes.
In PNH patients, uncontrolled terminal complement activation and the resulting complement-mediated intravascular haemolysis is blocked with Eculizumab treatment.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)No interaction studies have been performed. Based on the potential inhibitory effect of eculizumab on
complement-dependent cytotoxicity of rituximab, eculizumab may reduce the expected pharmacodynamic effects of rituximab.
Original license holder
Alexion Europe SAS
Marketing authorisation numbers
EU/1/07/393/001
Marketing authorisation holder
Alexion Europe SAS
103-105 rue Anatole France
92300 Levallois-Perret
FRANCE
Name of the manufacturer of the biological active substance
Lonza Biologics Tuas Pte Ltd.
35 Tuas South Avenue 6
Singapore 637377

Lonza Biologics Porriño, S.L.
C/ La Relba, s/n.
Porriño
Pontevedra 36400
Spain

Alexion Pharma International Operations Unlimited Company
College Business and Technology Park
Blanchardstown, Dublin 15
Ireland
Name and address of the manufacturer(s) responsible for batch releaseAlmac Pharma Services
22 Seagoe Industrial Estate
Craigavon BT63 5QD
United Kingdom

Patheon Italia S.p.A
Viale G. B. Stucchi, 110
20900 Monza (MB)
Italy

Alexion Pharma International Operations Unlimited Company
College Business and Technology Park
Blanchardstown
Dublin 15
Ireland
Max shelf life
30 months
Storage conditions
2°C – 8°C
List of excipients
Sodium phosphate, monobasic
Sodium phosphate, dibasic
Sodium chloride
Polysorbate 80
Water for injections
Evidentic Support
+49 (0) 30 959 99 8831

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