Bristol-Myers Squibb SA
Bristol-Myers Squibb SA holds 43 Swissmedic orphan drug statuses in Switzerland, covering 20 rare diseases.
10 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
- AbecmaAuthorised
- BreyanziAuthorised
- CamzyosAuthorised
- EmplicitiAuthorised
- ImnovidAuthorised
- OnuregAuthorised
- REVLIMIDAuthorised
- ReblozylAuthorised
- SprycelAuthorised
- VidazaAuthorised
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indication: the indication in the wording of the decision, the date the status was granted and, where the status was withdrawn, the withdrawal date.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| Orphan indication | Disease | Status granted | Status withdrawn |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 pulmonalen neuroendokrinen Karzinoms | Neuroendocrine tumours (NET) | 19/05/2026 | Status active |
| Idiopathische Lungenfibrose | Idiopathic pulmonary fibrosis (IPF) | 24/07/2025 | Status active |
| Behandlung des nicht-kleinzelligen Lungenkarzinoms mit KRAS-G12C-Mutation | Small cell lung cancer (SCLC) | 16/01/2025 | Status active |
| diffuses grosszelliges B-Zell-Lymphom | Diffuse large B-cell lymphoma (DLBCL) | 14/01/2025 | Status active |
| Multiples Myelom | Multiple myeloma | 14/11/2024 | Status active |
| Multiples Myelom | Multiple myeloma | 14/11/2024 | Status active |
| Follikuläres Lymphom | Follicular lymphoma | 25/10/2024 | Status active |
| Behandlung des Multiplen Myelom | Multiple myeloma | 24/10/2024 | Status active |
| Behandlung des multipen Myelom | Multiple myeloma | 21/10/2024 | Status active |
| Eosinophile Ösophagitis | Eosinophilic oesophagitis | 27/08/2024 | Status active |
| Mantelzelllymphom (MCL) | Mantle cell lymphoma | 30/07/2024 | Status active |
| Chronisch Lymphatische Leukämie (CLL) | Chronic lymphocytic leukaemia (CLL) | 25/01/2024 | Status active |
| Hochmalignes B-Zell Lymphom | High-grade B-cell lymphoma | 08/09/2022 | Status active |
| Behandlung der symptomatischen hypertrophen Kardiomyopathie | Symptomatic hypertrophic cardiomyopathy | 03/08/2021 | Status active |
| Follikuläres Lymphom | Follicular lymphoma | 14/05/2020 | Status active |
| Behandlung der akuten myeloischen Leukämie | Acute myeloid leukaemia (AML) | 30/03/2020 | Status active |
| Primär Mediastinales Grosszelliges B-Zell-Lymphom | Diffuse large B-cell lymphoma (DLBCL) | 05/02/2020 | Status active |
| Primäre und sekundäre Myelofibrose | Myelofibrosis | 15/10/2019 | Status active |
| Behandlung des multiplen Myelom | Multiple myeloma | 15/08/2019 | Status active |
| Behandlung der β-Thalassämie (Intermediäre und Major-Form) | Beta thalassaemia | 11/07/2019 | Status active |
| Behandlung der β-Thalassämie (Intermediäre und Major-Form) | Beta thalassaemia | 11/07/2019 | Status active |
| Behandlung der myelodysplastischen Syndrome | Myelodysplastic syndromes (MDS) | 13/06/2019 | Status active |
| Behandlung der myelodysplastischen Syndrome | Myelodysplastic syndromes (MDS) | 13/06/2019 | Status active |
| Diffuses grosszelliges B-Zell-Lymphom (DLBCL) | Diffuse large B-cell lymphoma (DLBCL) | 06/06/2019 | Status active |
| Behandlung des Marginalzonen-Lymphoms (MZL) | Marginal zone lymphoma (MZL) | 27/09/2017 | Status active |
| Akute Myeloische Leukämie | Acute myeloid leukaemia (AML) | 06/07/2017 | Status active |
| Behandlung des follikulären Lymphoms (FL) | Follicular lymphoma | 28/05/2013 | Status active |
| Behandlung des multiplen Myeloms | Multiple myeloma | 12/10/2012 | Status active |
| Behandlung der systemischen Sklerose | Systemic sclerosis (scleroderma) | 19/07/2012 | 28/06/2016 |
| Behandlung von Mantelzell-Lymphom (MCL) | Mantle cell lymphoma | 28/02/2012 | Status active |
| Behandlung der akuten myeloischen Leukämie (AML) | Acute myeloid leukaemia (AML) | 02/12/2011 | Status active |
| Behandlung des hepatozellulären Karzinoms | Hepatocellular carcinoma (HCC) | 28/11/2011 | 22/11/2013 |
| Behandlung des Myelodysplastischen Syndroms (MDS) | Myelodysplastic syndromes (MDS) | 24/10/2011 | Status active |
| Behandlung der chronisch-lymphatischen Leukämie (CLL) | Chronic lymphocytic leukaemia (CLL) | 18/10/2011 | Status active |
| Behandlung von Diffus-Grosszelligem B-Zell Lymphom (DLBCL) | Diffuse large B-cell lymphoma (DLBCL) | 18/10/2011 | Status active |
| Behandlung einer Myelofibrose nach essentieller Thombozythämie | Myelofibrosis | 11/05/2011 | 04/01/2017 |
| Behandlung einer Myelofibrose nach Polycythaemia vera | Myelofibrosis | 11/05/2011 | 04/01/2017 |
| Behandlung der primären Myelofibrose | Myelofibrosis | 11/05/2011 | 04/01/2017 |
| Behandlung des multiplen Myeloms | Multiple myeloma | 02/12/2009 | Status active |
| Behandlung der myelodysplastischen Syndrome | Myelodysplastic syndromes (MDS) | 27/02/2008 | Status active |
| Behandlung des multiplen Myeloms | Multiple myeloma | 28/06/2007 | Status active |
| Behandlung der chronischen myeloischen Leukämie | Chronic myeloid leukaemia (CML) | 29/01/2007 | Status active |
| Behandlung der akuten lymphoblastischen Leukämie | Acute lymphoblastic leukaemia (ALL) | 29/01/2007 | 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 Bristol-Myers Squibb SA?
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