Pfizer AG
Pfizer AG holds 26 Swissmedic orphan drug statuses in Switzerland, covering 19 rare diseases.
12 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
- AtgamAuthorised
- BesponsaAuthorised
- BosulifAuthorised
- ElrexfioTemporarily authorised
- HympavziAuthorised
- InlytaAuthorised
- MylotargAuthorised
- NgenlaAuthorised
- SomavertAuthorised
- SutentAuthorised
- Vyndaqel 20 mgAuthorised
- Vyndaqel 61 mgAuthorised
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indication: the indication in the wording of the decision, the date the status was granted and, where the status was withdrawn, the withdrawal date.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| Orphan indication | Disease | Status granted | Status withdrawn |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 Patienten mit Hämophilie A (Häm A) und Hämophilie B (Häm B), mit oder ohne Inhibitoren, einschliesslich Routineprophylaxe zur Vorbeugung oder Verringerung der Blutungshäufigkeit bei Patienten mit Hämophilie A und Hämophilie B | Haemophilia A | 14/11/2023 | Status active |
| Behandlung der Sichelzellanämie | Sickle cell disease | 14/09/2023 | Status active |
| Behandlung der Hämophilie A | Haemophilia A | 13/06/2023 | Status active |
| Behandlung der Duchenne-Muskeldystrophie | Duchenne muscular dystrophy | 26/01/2023 | Status active |
| Hämophilie B | Haemophilia B | 08/11/2022 | Status active |
| Aplastische Anämie | Aplastic anaemia | 06/09/2022 | Status active |
| Multiples Myelom | Multiple myeloma | 09/09/2021 | Status active |
| Behandlung eines Wachstumshormonmangels | Growth hormone deficiency | 04/02/2021 | Status active |
| Behandlung von akuter myeloischer Leukämie | Acute myeloid leukaemia (AML) | 13/05/2019 | Status active |
| Behandlung der symptomatischen Transthyretin (TTR) Amyloid Kardiomyopathie | Transthyretin amyloidosis (ATTR) | 13/09/2018 | Status active |
| Behandlung der symptomatischen Transthyretin (TTR) Amyloid Kardiomyopathie | Transthyretin amyloidosis (ATTR) | 13/09/2018 | Status active |
| Nicht-kleinzelliges Lungenkarzinom (NSCLC) bei Patienten mit EGFR, HER2, HER4 oder DDR2 Mutationen | Small cell lung cancer (SCLC) | 19/09/2017 | Status active |
| Behandlung der akuten lymphoblastischen Leukämie vom B-Zell-Typ | Acute lymphoblastic leukaemia (ALL) | 17/06/2015 | Status active |
| Behandlung der familiären Amyloid-Polyneuropathie | Familial amyloid polyneuropathy | 12/12/2011 | Status active |
| Behandlung der chronischen myeloischen Leukämie | Chronic myeloid leukaemia (CML) | 11/04/2011 | Status active |
| Behandlung des Nierenzellkarzinoms | Renal cell carcinoma | 04/04/2011 | Status active |
| Behandlung von ALK-positivem nicht-kleinzelligem Lungenkarzinom | Small cell lung cancer (SCLC) | 17/12/2010 | 22/01/2015 |
| Behandlung der pulmonalen arteriellen Hypertonie und der chronischen thromboembolischen pulmonalen Hypertonie | Pulmonary arterial hypertension (PAH) | 01/07/2010 | Status active |
| Behandlung von neuroendokrinen Tumoren des Pankreas | Neuroendocrine tumours (NET) | 21/12/2009 | Status active |
| Behandlung des Mantelzell-Lymphoms | Mantle cell lymphoma | 21/12/2009 | Status active |
| Akromegalie | Acromegaly | 13/11/2007 | Status active |
| Behandlung des metastasierenden Inselzellkarzinoms der Bauchspeicheldrüse | Pancreatic islet cell carcinoma | 24/08/2007 | Status active |
| Behandlung der pulmonalen arteriellen Hypertonie und der chronisch thromboembolischen pulmonalen Hypertonie | Pulmonary arterial hypertension (PAH) | 07/05/2007 | Status active |
| Therapie von malignen gastrointestinalen Stromatumoren (GIST), Behandlung des Nierenzellkarzinoms | Renal cell carcinoma | 29/01/2007 | Status active |
| Behandlung von Patienten mit akuter myeloischer Leukämie | Acute myeloid leukaemia (AML) | 09/01/2007 | Status active |
| Behandlung des fortgeschrittenen Nierenzellkarzinoms | Renal cell carcinoma | 14/12/2006 | 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 Pfizer 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