Ultomiris
Ultomiris, Konzentrat zur Herstellung einer Infusionslösung
Ultomiris is a medicine with orphan drug status in Switzerland, active substance ravulizumabum, authorisation holder Alexion Pharma GmbH. Swissmedic publishes 6 orphan indications for this product.
The medicine is authorised under number 67278, first authorised on 20/01/2020.
Data
Data from the Swissmedic list of medicinal products with orphan drug status (Art. 7 TPLO), as of 2026-09-18. Swissmedic updates the list every month.
| Active substances | ravulizumabum |
|---|---|
| Authorisation holder | Alexion Pharma GmbH |
| Authorisation number | 67278 |
| Authorisation status | Authorised |
| First authorised | 20/01/2020 |
| Temporary until | - |
| Authorised indication | paroxysmale nächtliche Hämoglobinurie (PNH); atypisches Hämolytisch-Urämisches Syndrom (aHUS); generalisierte Myasthenia gravis, Neuromyelitis-optica-Spektrum-Erkrankungen (NMOSD) |
Orphan designations
Swissmedic publishes one row per medicine and orphan indication: the indication in the wording of the decision, the date the status was granted and, where the status was withdrawn, the withdrawal date. The table below reproduces those rows unchanged and links every indication to the matching rare disease in the directory.
| Orphan indication | Disease | Status granted | Status withdrawn |
|---|---|---|---|
| Behandlung der primären IgA Nephropathie | Primary IgA nephropathy | 25/08/2026 | Status active |
| Behandlung der thrombotischen Mikroangiopathie nach hämatopoetischer Stammzelltransplantation (HSCT-TMA) | Conditioning before stem cell transplantation | 03/09/2025 | Status active |
| Behandlung von Neuromyelitis-optica-Spektrum-Erkrankungen (NMOSD) | Neuromyelitis optica spectrum disorder (NMOSD) | 27/02/2023 | Status active |
| Behandlung von Myasthenia Gravis (MG) | Myasthenia gravis | 22/06/2022 | Status active |
| Behandlung des atypischen hämolytisch-urämischen Syndroms (aHUS) | Atypical haemolytic uraemic syndrome (aHUS) | 13/07/2020 | Status active |
| Traitement de l'Hémoglobinurie paroxystique nocturne | Paroxysmal nocturnal haemoglobinuria (PNH) | 19/09/2019 | Status active |
Reimbursement
Whether compulsory health insurance pays for this medicine depends on the FOPH specialities list (SL). Medicines that are not listed can be reimbursed case by case under Art. 71a-71d KVV.
Frequently asked questions
Is Ultomiris authorised in Switzerland?
Yes. Ultomiris is authorised by Swissmedic under number 67278, first authorised on 20/01/2020. The product also carries orphan drug status for a rare disease.
What does orphan drug status mean for Ultomiris?
The status opens the simplified authorisation procedure (Art. 14 para. 1 let. f TPA), priority assessment, a waiver of the flat-rate fee for the new authorisation application (Art. 9 let. a FeeO-Swissmedic) and, on request, 15 years of document protection (Art. 11b para. 4 TPA).
Is Ultomiris reimbursed by Swiss health insurance?
That depends on the FOPH specialities list (SL), not on the orphan drug status. If the product is not listed, reimbursement in an individual case under Art. 71a to 71d KVV can apply. Check the current SL entry and public price in the FOPH specialities list.
Medicines
Bring your orphan drug to Switzerland
You can enquire about orphan drug status, authorisation and reimbursement in Switzerland. Any specialist service and its scope are agreed separately with the external partner.
- Public Swissmedic data
- Four language versions