Soliris (eculizumab)
- Region
- 🇪🇺 EU
- Active substance
- eculizumab
- Company
- Alexion Europe SAS
- Status
- Authorised
- Therapeutic area
- Hemoglobinuria, Paroxysmal
- EU approval
- Wed 20 Jun 2007
- Designations
- Orphan, Accelerated assessment
- Application
- EMEA/H/C/000791
- ATC
- L04AA25
- Official record
- www.ema.europa.eu
Indication
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Bekemv Authorised · Amgen Europe B.V.
- 🇪🇺 Epysqli Authorised · Samsung Bioepis NL B.V.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.