Temporary authorisations
Medicines with a temporary authorisation under Art. 9a TPA: authorised with conditions because no equivalent alternative is available for a life-threatening disease.
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.
| Medicine | Active substance | Authorisation holder | Authorisation number | Temporary until |
|---|---|---|---|---|
| Casgevy | exagamglogenum autotemcelum | Vertex Pharmaceuticals (CH) GmbH | 68978 | 05/09/2026 |
| Talvey | talquetamabum | Janssen-Cilag AG | 69049 | 31/12/2026 |
| Idefirix | imlifidasum | IQONE HEALTHCARE SWITZERLAND SA | 68373 | 05/02/2027 |
| Lunsumio subkutan | mosunetuzumabum | Roche Pharma (Schweiz) AG | 70221 | 09/02/2027 |
| Lunsumio | mosunetuzumabum | Roche Pharma (Schweiz) AG | 68314 | 09/02/2027 |
| Tepkinly 4 mg/0 | epcoritamabum | AbbVie AG | 69161 | 05/05/2027 |
| Tepkinly 48 mg/0 | epcoritamabum | AbbVie AG | 69481 | 05/05/2027 |
| Elrexfio | elranatamabum | Pfizer AG | 68646 | 30/09/2027 |
| Spevigo | spesolimabum | Leo Pharmaceutical Products Sarath Ltd. | 68625 | 21/10/2027 |
| Lyvdelzi | seladelparum | Gilead Sciences Switzerland Sàrl | 70063 | 09/12/2027 |
| Qalsody | tofersenum | Biogen Switzerland AG | 68577 | 18/12/2027 |
| Lytgobi | futibatinibum | Taiho Oncology Europe GmbH | 69714 | 31/01/2028 |
| Ezmekly | mirdametinibum | Merck (Schweiz) AG | 70387 | 09/04/2028 |
| Ezmekly | mirdametinibum | Merck (Schweiz) AG | 70392 | 09/04/2028 |
| Ojemda | tovorafenibum | IPSEN Pharma Schweiz GmbH | 70260 | 05/05/2028 |
| Ojemda | tovorafenibum | IPSEN Pharma Schweiz GmbH | 70241 | 05/05/2028 |
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 Temporary authorisations?
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