SOLIRIS Concentrate for solution for infusion Ref.[8919] Active ingredients: Eculizumab

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Alexion Europe SAS, 103-105 rue Anatole France, 92300, Levallois-Perret, FRANCE

Product name and form

Soliris 300 mg concentrate for solution for infusion.

Pharmaceutical Form

Concentrate for solution for infusion.

Clear, colorless, pH 7.0 solution.

Qualitative and quantitative composition

Eculizumab is a humanised monoclonal (IgG2/4Îș) antibody produced in NS0 cell line by recombinant DNA technology.

One vial of 30 ml contains 300 mg of eculizumab (10 mg/ml).

After dilution, the final concentration of the solution to be infused is 5 mg/ml.

Excipients with known effect: Sodium (5 mmol per vial)

For the full list of excipients, see section 6.1.

Active Ingredient Description

Eculizumab is a monoclonal antibody, 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.

List of Excipients

Sodium phosphate, monobasic
Sodium phosphate, dibasic
Sodium chloride
Polysorbate 80
Water for injections

Pack sizes and marketing

30 ml of concentrate in a vial (Type I glass) with a stopper (butyl, siliconised), and a seal (aluminium) with flip-off cap (polypropylene).

Pack size of one vial.

Marketing authorization holder

Alexion Europe SAS, 103-105 rue Anatole France, 92300, Levallois-Perret, FRANCE

Marketing authorization dates and numbers


Date of first authorisation: 20 June 2007
Date of latest renewal: 18 June 2012


Drug Countries
SOLIRIS Austria, Australia, Brazil, Canada, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States

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