Takeda Pharma AG
Takeda Pharma AG holds 31 Swissmedic orphan drug statuses in Switzerland, covering 26 rare diseases.
16 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
- AdcetrisAuthorised
- AdzynmaAuthorised
- AlunbrigAuthorised
- CeprotinAuthorised
- ElapraseAuthorised
- FirazyrAuthorised
- LivtencityAuthorised
- NinlaroAuthorised
- PlenadrenAuthorised
- ReplagalAuthorised
- RevestiveAuthorised
- RixubisAuthorised
- TAKHZYROAuthorised
- TAKHZYROAuthorised
- VEYVONDIAuthorised
- VPRIVAuthorised
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indication: the indication in the wording of the decision, the date the status was granted and, where the status was withdrawn, the withdrawal date.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| Orphan indication | Disease | Status granted | Status withdrawn |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 der Polycythemia vera | Polycythaemia vera | 12/01/2026 | Status active |
| Behandlung der Narkolepsie | Narcolepsy | 01/05/2025 | Status active |
| Prophylaxe von thrombotischer- thrombozytopenischer Purpura einschliesslich deren kongenitalen, erworbenen idiopathischen, und sekundärer Formen. | Thrombotic thrombocytopenic purpura (TTP) | 12/12/2023 | Status active |
| Behandlung von thrombotischer- thrombozytopenischer Purpura einschliesslich deren kongenitalen, erworbenen idiopathischen, und sekundärer Formen. | Thrombotic thrombocytopenic purpura (TTP) | 12/12/2023 | Status active |
| Die Behandlung von klinisch signifikanter Cytomegalovirus (CMV) -Virämie und -Erkrankung bei Risikopatienten. | Cytomegalovirus infection (CMV) | 29/07/2021 | Status active |
| Behandlung der akuten myeloischen Leukämie | Acute myeloid leukaemia (AML) | 03/06/2021 | 07/04/2022 |
| Behandlung der myelodysplastischen Syndrome | Myelodysplastic syndromes (MDS) | 25/03/2021 | 07/04/2022 |
| Behandlung von nicht-kleinzelligem Lungenkrebs (NSCLC) mit genetischer Veränderung des Epidermalen Wachstumsfaktorrezeptors (EGFR), einschliesslich EGFR-Mutationen und / oder EGFR-Genamplifikation, HER2-Mutationen oder BRAF G466V-Mutationen. | Small cell lung cancer (SCLC) | 06/10/2020 | 10/10/2024 |
| Behandlung des peripheren T-Zell-Lymphoms | Peripheral T-cell lymphoma (PTCL) | 28/10/2019 | Status active |
| Behandlung des hereditären Angioödems | Hereditary angioedema (HAE) | 20/12/2017 | Status active |
| Behandlung des hereditären Angioödems | Hereditary angioedema (HAE) | 20/12/2017 | Status active |
| kutanes T-Zell Lymphom | Cutaneous T-cell lymphoma | 13/07/2017 | Status active |
| ALK-positives, ROS1-positives oder EGFR-positives nicht-kleinzelliges Lungenkarzinom (NSCLC) | Small cell lung cancer (SCLC) | 03/07/2017 | Status active |
| Behandlung der von-Willebrand-Krankheit | Von Willebrand disease | 02/03/2017 | Status active |
| Behandlung von Analfisteln | Anal fistulas | 15/09/2016 | Status active |
| Systemische Leichtketten-Amyloidose (AL) | AL amyloidosis (light-chain amyloidosis) | 11/02/2015 | Status active |
| Multiples Myelom | Multiple myeloma | 11/02/2015 | Status active |
| Behandlung von Kurzdarmsyndrom | Short bowel syndrome | 07/11/2014 | Status active |
| Behandlung der Hämophilie A | Haemophilia A | 04/11/2014 | Status active |
| Behandlung der Kontrolle und Prophylaxe von Blutungen und für routine und chirurgische Prophylaxe bei Patienten mit Hemophilie B (angeborener Mangel an Faktor IX) | Haemophilia B | 24/01/2013 | Status active |
| Behandlung eines durch C1-Inhibitor Mangel bedingten Angioödems | Hereditary angioedema (HAE) | 15/12/2011 | Status active |
| Behandlung der Nebennierenrindeninsuffizienz (M. Addison) | Adrenal insufficiency | 23/08/2011 | Status active |
| Behandlung des Hodgkin-Lymphoms | Hodgkin lymphoma | 09/12/2010 | Status active |
| Behandlung des anaplastischen grosszelligen Lymphoms | Anaplastic large cell lymphoma (ALCL) | 09/12/2010 | Status active |
| Enzymersatztherapie bei Typ 1 Morbus Gaucher | Gaucher disease | 05/05/2010 | Status active |
| Ceprotin ist indiziert bei Patienten mit schwerem kongenitalem Protein-C-Mangel zur Prophylaxe und Behandlung von Venenthrombosen und von Purpura fulminans. Ceprotin ist indiziert als Ersatztherapie für pädiatrische und erwachsene Patienten | Severe congenital protein C deficiency | 17/12/2009 | Status active |
| Behandlung des Osteosarkoms | Osteosarcoma | 09/10/2009 | Status active |
| Enzymersatz-Therapie bei Patienten mit Morbus Fabry (alfa-Galaktosidase-A-Mangel) | Fabry disease | 03/06/2008 | Status active |
| Behandlung der manifesten nicht dilatativen Kardiomyopathie bei Patienten mit Friedreich-Ataxie | Friedreich ataxia | 29/02/2008 | Status active |
| Symptomatische Behandlung akuter Attacken eines hereditären Angioödems (HAE) bei Erwachsenen (mit C1-Esterase-Inhibitor-Mangel) | Hereditary angioedema (HAE) | 29/01/2007 | Status active |
| Langzeitbehandlung von Patienten mit Hunter-Syndrom (Mukopolysaccharidose II, MPS II) | Mucopolysaccharidoses (MPS) | 30/10/2006 | 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 Takeda Pharma 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