Soliris
Soliris ingredients
| Active ingredient | Strength |
|---|---|
| Eculizumab | 300 mg/30mL |
What Soliris is used for
The FDA lists the approved uses on the official label (below). In the EU, eculizumab is approved as Soliris for:
Soliris is indicated in adults and children for the treatment of: Paroxysmal nocturnal haemoglobinuria (PNH). Evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history (see section 5.1). Atypical haemolytic uremic syndrome (aHUS). Soliris is indicated in adults for the treatment of: Refractory generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR) antibody-positive (see section 5.1). Neuromyelitis optica spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease.
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Soliris
- Generic name
- Eculizumab
- Made by
- Alexion Pharmaceuticals Inc.
- Forms
- Injection, Solution, Concentrate
- Given
- Intravenous
- Drug class
- Complement Inhibitor
- FDA approval
- Biologic licence (BLA) BLA125166
- On the US market since
- 2007
Official information
- Soliris prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Eculizumab)
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 Soliris?
Soliris (Eculizumab) is a specialist medicine made by Alexion Pharmaceuticals Inc., approved by the US FDA.
What are the ingredients of Soliris?
Soliris contains Eculizumab (300 mg/30mL).
Is Soliris approved in Europe?
The same active substance is approved in the EU as Soliris.
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