Ilaris
Ilaris, Injektionslösung
Ilaris is a medicine with orphan drug status in Switzerland, active substance canakinumabum, authorisation holder Novartis Pharma Schweiz AG. Swissmedic publishes 6 orphan indications for this product.
The medicine is authorised under number 66191, first authorised on 15/05/2017.
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 | canakinumabum |
|---|---|
| Authorisation holder | Novartis Pharma Schweiz AG |
| Authorisation number | 66191 |
| Authorisation status | Authorised |
| First authorised | 15/05/2017 |
| Temporary until | - |
| Authorised indication | Cryopyrin-assoziierte Periodische Syndrome (CAPS) wie des Muckle-Wells-Syndroms (MWS), des familiären autoinflammatorischen Kälte-Syndroms (FACS) / der familiären Kälteurtikaria (FCU) und der multisystemischen entzündlichen Erkrankung mit Beginn im Neugeborenenalter (NOMID)/des chronischen infantilen neuro-dermo-artikulären Syndroms (CINCA). Tumornekrosefaktor-Rezeptor-assoziiertes periodisches Syndrom (TRAPS). Hyperimmunglobulin-D-Syndrom (HIDS) / Mevalonatkinasedefizienz (MKD). Familiäres Mittelmeerfieber (FMF). Systemische juvenile idiopathische Arthritis (SJIA). Adultes Still-Syndrom. |
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indication: the indication in the wording of the decision, the date the status was granted and, where the status was withdrawn, the withdrawal date.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| Orphan indication | Disease | Status granted | Status withdrawn |
|---|---|---|---|
| Adultes Still-Syndrom | Adult-onset Still disease | 18/12/2017 | Status active |
| Behandlung des Hyperimmunglobulin-D- und periodischen Fiebersyndroms (HIDS) | Hyperimmunoglobulin D syndrome (HIDS) | 15/11/2016 | Status active |
| Behandlung der Cryopyrin-assoziierten periodischen Syndrome | Cryopyrin-associated periodic syndromes (CAPS) | 15/11/2016 | Status active |
| Behandlung des familiären Mittelmeerfiebers | Familial Mediterranean fever (FMF) | 15/11/2016 | Status active |
| Behandlung der pädiatrischen juvenilen rheumatoiden Arthritis | Juvenile rheumatoid arthritis | 15/11/2016 | Status active |
| Behandlung des TNF-Rezeptor-assoziierten periodischen Syndroms (TRAPS) | TNF receptor-associated periodic syndrome (TRAPS) | 15/11/2016 | 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 Ilaris authorised in Switzerland?
Yes. Ilaris is authorised by Swissmedic under number 66191, first authorised on 15/05/2017. The product also carries orphan drug status for a rare disease.
What does orphan drug status mean for Ilaris?
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 Ilaris 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.
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