imatinibum
The active substance imatinibum carries 10 Swissmedic orphan drug statuses in Switzerland, across 8 rare diseases.
3 medicines containing it are published with an authorisation number. The rarity criterion of 5 per 10,000 people applies to the disease in its entirety and per active substance, across all indications with status (Art. 6 TPLO).
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indication: the indication in the wording of the decision, the date the status was granted and, where the status was withdrawn, the withdrawal date.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| Orphan indication | Disease | Status granted | Status withdrawn |
|---|---|---|---|
| Maligne gastrointestinale Strumatumoren (GIST) | Gastrointestinal stromal tumours (GIST) | 21/12/2017 | Status active |
| Pulmonal-arterielle Hypertonie | Pulmonary arterial hypertension (PAH) | 14/12/2010 | Status active |
| maligne gastrointestinale Stromatumoren (GIST) | Gastrointestinal stromal tumours (GIST) | 06/05/2008 | Status active |
| myelodysplasiche/myeloproliferative Erkrankungen (MDS/MPD) | Myelodysplastic syndromes (MDS) | 06/05/2008 | Status active |
| chronisch eosinophile Leukämie / Hypereosinophilensyndrom (HES/CEL) | Chronic eosinophilic leukaemia and hypereosinophilic syndrome | 06/05/2008 | Status active |
| Dermatofibrosarkom protuberans (DFSP) | Dermatofibrosarcoma protuberans (DFSP) | 06/05/2008 | Status active |
| aggressive systemische Mastozytose (SM) | Mastocytosis | 06/05/2008 | Status active |
| maligne gastrointestinale Stromatumoren (GIST) | Gastrointestinal stromal tumours (GIST) | 06/05/2008 | Status active |
| Ph+ chronisch myeloische Leukämie (Ph+ CML) | Chronic myeloid leukaemia (CML) | 06/05/2008 | Status active |
| Ph+ akute lymphatisch Leukämie (Ph+ ALL) | Acute lymphoblastic leukaemia (ALL) | 06/05/2008 | Status active |
Reimbursement
Whether a medicine containing this active substance is 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 imatinibum?
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.
Active substances
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