Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Alexion Europe SAS, 103-105 rue Anatole France, 92300 Levallois-Perret, FRANCE
Ultomiris 300 mg/3 mL concentrate for solution for infusion.
Ultomiris 1,100 mg/11 mL concentrate for solution for infusion.
Ultomiris 300 mg/30 mL concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
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Concentrate for solution for infusion (sterile concentrate). Ultomiris 300 mg/3 mL and 1 100 mg/11 mL concentrates for solution for infusion: Translucent, clear to yellowish colour, pH 7.4 solution. Ultomiris 300 mg/30 mL concentrate for solution for infusion: Clear to translucent, slight whitish colour, pH 7.0 solution. |
Ultomiris is a formulation of ravulizumab produced in Chinese hamster ovary (CHO) cell culture by recombinant DNA technology.
Each vial of 3 mL contains 300 mg of ravulizumab (100 mg/mL). After dilution, the final concentration of the solution to be infused is 50 mg/mL.
Excipient(s) with known effect: Sodium (4.6 mg per 3 mL vial).
Each vial of 11 mL contains 1 100 mg of ravulizumab (100 mg/mL). After dilution, the final concentration of the solution to be infused is 50 mg/mL.
Excipient(s) with known effect: Sodium (16.8 mg per 11 mL vial).
Each vial of 30 mL contains 300 mg of ravulizumab (10 mg/mL). After dilution, the final concentration of the solution to be infused is 5 mg/mL.
Excipient(s) with known effect: Sodium (115 mg per 30 mL vial).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ravulizumab |
Ravulizumab is a monoclonal antibody IgG2/4K that specifically binds to the complement protein C5, thereby inhibiting its cleavage to C5a (the proinflammatory anaphylatoxin) and C5b (the initiating subunit of the terminal complement complex [C5b-9]) and preventing the generation of the C5b-9. Ravulizumab preserves the early components of complement activation that are essential for opsonisation of microorganisms and clearance of immune complexes. |
| List of Excipients |
|---|
|
Ultomiris 300 mg/3 mL and 1,100 mg/11 mL concentrates for solution for infusion: Sodium phosphate dibasic heptahydrate Ultomiris 300 mg/30 mL concentrate for solution for infusion: Sodium phosphate dibasic heptahydrate |
Pack size of one vial.
Ultomiris 300 mg/3 mL concentrate for solution for infusion: 3 mL of sterile concentrate in a vial (Type I glass) with a stopper and a seal.
Ultomiris 1 100 mg/11 mL concentrate for solution for infusion: 11 mL of sterile concentrate in a vial (Type I glass) with a stopper and a seal.
Ultomiris 300 mg/30 mL concentrate for solution for infusion: 30 mL of sterile concentrate in a vial (Type I glass) with a stopper and a seal.
Alexion Europe SAS, 103-105 rue Anatole France, 92300 Levallois-Perret, FRANCE
EU/1/19/1371/001
EU/1/19/1371/002
EU/1/19/1371/003
Date of first authorisation: 02 July 2019
Date of latest renewal: 19 April 2024
| Drug | Countries | |
|---|---|---|
| ULTOMIRIS | Austria, Ecuador, Estonia, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania, United Kingdom, United States |
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