Source: European Medicines Agency (EU) Revision Year: 2022 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. It is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH). |
| 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
| Drug | Countries | |
|---|---|---|
| ULTOMIRIS | Austria, Ecuador, Estonia, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania, United Kingdom, United States |
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