Opsumit
Opsumit, Filmtabletten
Opsumit is a medicine with orphan drug status in Switzerland, active substance macitentanum, authorisation holder Janssen-Cilag AG. Swissmedic publishes 2 orphan indications for this product.
The medicine is authorised under number 61863, first authorised on 06/02/2014.
Data
Data from the Swissmedic list of medicinal products with orphan drug status (Art. 7 TPLO), as of 2026-09-18. Swissmedic updates the list every month.
| Active substances | macitentanum |
|---|---|
| Authorisation holder | Janssen-Cilag AG |
| Authorisation number | 61863 |
| Authorisation status | Authorised |
| First authorised | 06/02/2014 |
| Temporary until | - |
| Authorised indication | Pulmonale arterielle Hypertonie |
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indication: the indication in the wording of the decision, the date the status was granted and, where the status was withdrawn, the withdrawal date.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| Orphan indication | Disease | Status granted | Status withdrawn |
|---|---|---|---|
| Chronisch thromboembolische pulmonale Hypertonie (CTEPH) | Chronic thromboembolic pulmonary hypertension (CTEPH) | 10/01/2019 | Status active |
| Pulmonale arterielle Hypertonie und idiopathische pulmonale Fibrose | Pulmonary arterial hypertension (PAH) | 30/08/2010 | Status active |
Reimbursement
Whether compulsory health insurance pays for this medicine depends on the FOPH specialities list (SL). Medicines that are not listed can be reimbursed case by case under Art. 71a-71d KVV.
Frequently asked questions
Is Opsumit authorised in Switzerland?
Yes. Opsumit is authorised by Swissmedic under number 61863, first authorised on 06/02/2014. The product also carries orphan drug status for a rare disease.
What does orphan drug status mean for Opsumit?
The status opens 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 (Art. 9 let. a FeeO-Swissmedic) and, on request, 15 years of document protection (Art. 11b para. 4 TPA).
Is Opsumit reimbursed by Swiss health insurance?
That depends on the FOPH specialities list (SL), not on the orphan drug status. If the product is not listed, reimbursement in an individual case under Art. 71a to 71d KVV can apply. Check the current SL entry and public price in the FOPH specialities list.
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