AstraZeneca AG
AstraZeneca AG holds 10 Swissmedic orphan drug statuses in Switzerland, covering 10 rare diseases.
3 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
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indication: the indication in the wording of the decision, the date the status was granted and, where the status was withdrawn, the withdrawal date.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| Orphan indication | Disease | Status granted | Status withdrawn |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 des grosszelligen B-Zell Lymphoms (LBCL) | Diffuse large B-cell lymphoma (DLBCL) | 07/07/2026 | Status active |
| Behandlung des follikulären Lymphoms | Follicular lymphoma | 26/02/2026 | Status active |
| Behandlung der B-lymphoblastischen Leukämie/des B-lymphoblastischen Lymphoms | Acute lymphoblastic leukaemia (ALL) | 26/02/2026 | Status active |
| Behandlung der Transthyretin-vermittelten Amyloidose (ATTRv) | Transthyretin amyloidosis (ATTR) | 12/06/2023 | Status active |
| Hepatozelluläres Karzinom | Hepatocellular carcinoma (HCC) | 15/11/2021 | Status active |
| Haarzellenleukämie (HZL) | Hairy cell leukaemia (HCL) | 11/03/2019 | Status active |
| Lymphoplasmozytisches Lymphom (Morbus Waldenström) | Waldenström macroglobulinaemia (lymphoplasmacytic lymphoma) | 17/01/2017 | Status active |
| Chronische lymphatische Leukämie / kleinzelliges lymphozytisches Lymphom | Chronic lymphocytic leukaemia (CLL) | 17/01/2017 | Status active |
| Mantelzell-Lymphom | Mantle cell lymphoma | 17/01/2017 | Status active |
| Ovarialkarzinom | Ovarian cancer | 22/04/2013 | 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 AstraZeneca AG?
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