Fabhalta
Fabhalta, Hartkapseln
Fabhalta is a medicine with orphan drug status in Switzerland, active substance iptacopanum, authorisation holder Novartis Pharma Schweiz AG. Swissmedic publishes 3 orphan indications for this product.
The medicine is authorised under number 68603, first authorised on 29/08/2024.
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 | iptacopanum |
|---|---|
| Authorisation holder | Novartis Pharma Schweiz AG |
| Authorisation number | 68603 |
| Authorisation status | Authorised |
| First authorised | 29/08/2024 |
| Temporary until | - |
| Authorised indication | Als Monotherapie für die Behandlung erwachsener Patienten mit paroxysmaler nächtlicher Hämoglobinurie (PNH), die trotz einer mindestens 6-monatigen Behandlung mit einem C5-Inhibitor unzureichend angesprochen hatten. Zur Behandlung erwachsener Patienten mit Komplement-3-Glomerulopathie (C3G) in Kombination mit einem Renin-Angiotensin-System (RAS)-Inhibitor oder bei Patienten, die intolerant gegen RAS-Inhibitoren sind oder bei denen ein RAS-Inhibitor kontraindiziert ist. |
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indication: the indication in the wording of the decision, the date the status was granted and, where the status was withdrawn, the withdrawal date.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| Orphan indication | Disease | Status granted | Status withdrawn |
|---|---|---|---|
| C3-Glomerulopathie | C3 glomerulopathy | 02/11/2021 | Status active |
| Paroxysmale nächtliche Hämoglobinurie | Paroxysmal nocturnal haemoglobinuria (PNH) | 02/11/2021 | Status active |
| Primäre IgA-Nephropathie | Primary IgA nephropathy | 02/11/2021 | 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 Fabhalta authorised in Switzerland?
Yes. Fabhalta is authorised by Swissmedic under number 68603, first authorised on 29/08/2024. The product also carries orphan drug status for a rare disease.
What does orphan drug status mean for Fabhalta?
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 Fabhalta 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