Roche Pharma (Schweiz) AG
Roche Pharma (Schweiz) AG holds 33 Swissmedic orphan drug statuses in Switzerland, covering 25 rare diseases.
13 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
- AlecensaAuthorised
- ColumviAuthorised
- EnspryngAuthorised
- EsbrietAuthorised
- EvrysdiAuthorised
- EvrysdiAuthorised
- GazyvaroAuthorised
- HemlibraAuthorised
- Lunsumio subkutanTemporarily authorised
- LunsumioTemporarily authorised
- PiaskyAuthorised
- PolivyAuthorised
- RozlytrekAuthorised
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indication: the indication in the wording of the decision, the date the status was granted and, where the status was withdrawn, the withdrawal date.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| Orphan indication | Disease | Status granted | Status withdrawn |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 Uveitischen Makulaödems | Uveitic macular oedema | 25/06/2026 | Status active |
| Paroxismale nächtliche Hämoglobinurie (PNH) | Paroxysmal nocturnal haemoglobinuria (PNH) | 28/03/2023 | Status active |
| Behandlung von Myasthenia gravis. | Myasthenia gravis | 05/02/2023 | 13/12/2024 |
| Duchenne-Muskeldystrophie (DMD) | Duchenne muscular dystrophy | 18/05/2022 | Status active |
| Behandlung des diffusen grosszelligen B-Zell-Lymphoms | Diffuse large B-cell lymphoma (DLBCL) | 06/12/2021 | Status active |
| Follikuläres Lymphom (FL)) | Follicular lymphoma | 19/08/2021 | Status active |
| Follikuläres Lymphom (FL)) | Follicular lymphoma | 19/08/2021 | Status active |
| Behandlung der Neuromyelitis optica (NMO) und Neuromyelitis-optica-Spektrum-Erkrankungen (NMOSD) | Neuromyelitis optica spectrum disorder (NMOSD) | 10/10/2019 | Status active |
| zur Behandlung der Huntington-Krankheit | Huntington disease | 07/10/2019 | Status active |
| Behandlung des TrkA-positiven, TrkB-positiven, TrkC-positiven, ROS1-positiven und ALK-positiven nicht-kleinzelligen Lungenkarzinoms | Small cell lung cancer (SCLC) | 26/03/2019 | Status active |
| Behandlung der NTRK Fusion-Positiven Soliden Tumoren | Solid tumours with NTRK gene fusion | 26/03/2019 | Status active |
| Behandlung der spinalen muskulären Atrophie | Spinal muscular atrophy (SMA) | 15/10/2018 | Status active |
| Behandlung der spinalen muskulären Atrophie | Spinal muscular atrophy (SMA) | 15/10/2018 | Status active |
| Behandlung des diffus grosszelligen B-Zell-Lymphoms (DLBCL) | Diffuse large B-cell lymphoma (DLBCL) | 12/06/2018 | Status active |
| Behandlung von Hämophilie A | Haemophilia A | 17/11/2016 | Status active |
| Behandlung von Mesotheliom | Malignant mesothelioma | 31/10/2016 | 28/02/2025 |
| Behandlung von ALK-positivem nicht-kleinzelligem Lungenkarzinom | Small cell lung cancer (SCLC) | 09/02/2016 | Status active |
| Behandlung systemischer Sklerose (SSc) | Systemic sclerosis (scleroderma) | 15/01/2016 | Status active |
| Idiopathische pulmonale Fibrose (IPF) | Idiopathic pulmonary fibrosis (IPF) | 15/12/2015 | Status active |
| follikuläres B-Zell Non-Hodgkin-Lymphom (FL) | Follicular lymphoma | 15/07/2015 | Status active |
| Magenkarzinom inklusive des Karzinom des gastroösophagealen Übergangs | Gastric cancer | 26/09/2014 | 29/01/2024 |
| chronische lymphatische Leukämie | Chronic lymphocytic leukaemia (CLL) | 28/05/2013 | Status active |
| diffuses grosszelliges B-Zell-Lymphom | Diffuse large B-cell lymphoma (DLBCL) | 28/05/2013 | 12/11/2018 |
| Behandlung von Magenkarzinom in Kombination mit einem Platin und 5-FU oder Capecitabine | Gastric cancer | 05/05/2010 | 28/02/2025 |
| Behandlung von idiopathischer pulmonaler Fibrose | Idiopathic pulmonary fibrosis (IPF) | 22/12/2009 | Status active |
| Behandlung von Melanom der Stadien IIb bis IV als Teil einer Kombinationschemotherapie | Malignant melanoma | 07/12/2009 | 28/02/2025 |
| Behandlung von Patientinnen und Patienten mit B-Zell Non-Hodgkin-Lymphom | B-cell non-Hodgkin lymphoma | 30/11/2009 | Status active |
| Behandlung von Patientinnen mit Ovarialkarzinom | Ovarian cancer | 11/09/2009 | Status active |
| Behandlung von Patientinnen und Patienten mit ANCA (antineutrophile zytoplasmatische Antikörper)-assoziierter Vaskulitis (Wegener-Granulomatose, mikroskopische Polyangiitis, Churg-Strauss-Syndrom) | Granulomatosis with polyangiitis (Wegener granulomatosis) | 19/05/2009 | Status active |
| Behandlung von Patienten mit Pankreaskarzinom | Pancreatic cancer | 04/12/2008 | Status active |
| Behandlung der Idiopathischen thrombozytopenischen Purpura (ITP) | Immune thrombocytopenia (ITP) | 07/11/2008 | Status active |
| In Kombination mit Cyclosporin und Corticosteroiden zur Prophylaxe von akuten Transplantatabstossungsreaktionen bei Patienten mit allogener Nieren-, Herz- oder Lebertransplantation angezeigt | Transplant rejection after solid organ transplantation | 18/04/2008 | Status active |
| Behandlung bei malignen Glioma | Glioma and glioblastoma | 12/09/2007 | 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 Roche Pharma (Schweiz) 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