Ultomiris
Ultomiris ingredients
| Active ingredient | Strength |
|---|---|
| Ravulizumab | 300 mg/3mL, 1100 mg/11mL |
What Ultomiris is used for
The FDA lists the approved uses on the official label (below). In the EU, ravulizumab is approved as Ultomiris for:
Paroxysmal nocturnal haemoglobinuria (PNH)Ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with PNH:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity.- in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5.1). Atypical haemolytic uremic syndrome (aHUS)Ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with aHUS who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5.1). Generalized myasthenia gravis (gMG)Ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gMG who are anti-acetylcholine receptor (AChR) antibody-positive. Neuromyelitis Optic…
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Ultomiris
- Generic name
- Ravulizumab
- Made by
- Alexion Pharmaceuticals Inc.
- Forms
- Solution, Concentrate
- Given
- Intravenous
- Drug class
- Complement Inhibitor
- FDA approval
- Biologic licence (BLA) BLA761108
- On the US market since
- 2020
Official information
- MedlinePlus drug information (search for Ravulizumab)
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Ultomiris?
Ultomiris (Ravulizumab) is a specialist medicine made by Alexion Pharmaceuticals Inc., approved by the US FDA.
What are the ingredients of Ultomiris?
Ultomiris contains Ravulizumab (300 mg/3mL, 1100 mg/11mL).
Is Ultomiris approved in Europe?
The same active substance is approved in the EU as Ultomiris.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA