Gilead Sciences Switzerland Sàrl
Gilead Sciences Switzerland Sàrl holds 11 Swissmedic orphan drug statuses in Switzerland, covering 10 rare diseases.
5 of its medicines are published with an authorisation number. Placing a medicine on the Swiss market requires an authorisation holder domiciled in Switzerland; the orphan drug status application does not, where a Swiss postal address suffices.
Medicines
- CaystonAuthorised
- HepcludexAuthorised
- LyvdelziTemporarily authorised
- TecartusAuthorised
- YescartaAuthorised
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indication: the indication in the wording of the decision, the date the status was granted and, where the status was withdrawn, the withdrawal date.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| Orphan indication | Disease | Status granted | Status withdrawn |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 von Multiplem Myelom | Multiple myeloma | 26/05/2025 | Status active |
| Behandlung der primären biliären Cholangitis | Primary biliary cholangitis (PBC) | 08/11/2024 | Status active |
| Myelodysplastische Syndrome | Myelodysplastic syndromes (MDS) | 24/08/2021 | 24/10/2024 |
| Akute Lymphatische Leukämie | Acute lymphoblastic leukaemia (ALL) | 22/06/2021 | Status active |
| Hepatitis-Delta-Virus-Infektion | Hepatitis delta virus infection | 18/03/2021 | Status active |
| Marginalzonenlymphom | Marginal zone lymphoma (MZL) | 10/12/2020 | Status active |
| Mantelzell-Lymphom | Mantle cell lymphoma | 14/05/2020 | Status active |
| Behandlung des follikularen Lymphoms | Follicular lymphoma | 25/01/2018 | Status active |
| Behandlung des diffusen grosszelligen B-Zell-Lymphoms | Diffuse large B-cell lymphoma (DLBCL) | 25/01/2018 | Status active |
| Behandlung des primär mediastinalen grosszelligen B-Zell-Lymphoms | Diffuse large B-cell lymphoma (DLBCL) | 25/01/2018 | Status active |
| Behandlung von gram-negativen bakteriellen Lungeninfektionen bei zystischer Fibrose | Bacterial lung infection in cystic fibrosis | 05/12/2008 | Status active |
Reimbursement
Whether this company's medicines are paid for by compulsory health insurance depends on the FOPH specialities list (SL), not on the orphan drug status. Medicines that are not listed can be reimbursed case by case under Art. 71a-71d KVV.
Frequently asked questions
How does a medicine obtain orphan drug status in Switzerland?
On application to Swissmedic. It requires a life-threatening or chronically debilitating disease affecting no more than 5 in 10,000 people in Switzerland, or an existing recognition in a country with comparable medicinal product control (Art. 4 para. 1 let. a decies TPA, Art. 4 TPLO).
What does the status actually give you?
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 and, on request, 15 years of document protection (Art. 11b para. 4 TPA). There is no market exclusivity as in the EU.
How current is the data on Gilead Sciences Switzerland Sàrl?
Swissmedic publishes the list of medicinal products with orphan drug status under Art. 7 TPLO and updates it monthly. The date of the data set processed here is shown at the foot of every page.
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