Filsuvez
Filsuvez, Gel
Filsuvez is a medicine with orphan drug status in Switzerland, active substance betulae corticis extractum, authorisation holder Chiesi SA. Swissmedic publishes 1 orphan indication for this product.
The medicine is authorised under number 70069, first authorised on 25/07/2025.
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 | betulae corticis extractum |
|---|---|
| Authorisation holder | Chiesi SA |
| Authorisation number | 70069 |
| Authorisation status | Authorised |
| First authorised | 25/07/2025 |
| Temporary until | - |
| Authorised indication | Filsuvez est utilisé pour le traitement des plaies peu profondes associées à l'épidermolyse bulleuse (EB) dystrophique et jonctionnelle chez les patients dès l'âge de 6 mois. |
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indication: the indication in the wording of the decision, the date the status was granted and, where the status was withdrawn, the withdrawal date.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| Orphan indication | Disease | Status granted | Status withdrawn |
|---|---|---|---|
| épidermolyse bulleuse | Epidermolysis bullosa | 14/11/2024 | 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 Filsuvez authorised in Switzerland?
Yes. Filsuvez is authorised by Swissmedic under number 70069, first authorised on 25/07/2025. The product also carries orphan drug status for a rare disease.
What does orphan drug status mean for Filsuvez?
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 Filsuvez 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