Medicine

Reblozyl

Reblozyl, Pulver zur Herstellung einer Injektionslösung

AuthorisedAuthorisation number 695922 orphan indications

Reblozyl is a medicine with orphan drug status in Switzerland, active substance luspaterceptum, authorisation holder Bristol-Myers Squibb SA. Swissmedic publishes 2 orphan indications for this product.

The medicine is authorised under number 69592, first authorised on 21/05/2026.

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.

Reblozyl, Pulver zur Herstellung einer Injektionslösung
Active substancesluspaterceptum
Authorisation holderBristol-Myers Squibb SA
Authorisation number69592
Authorisation statusAuthorised
First authorised21/05/2026
Temporary until-
Authorised indicationMyelodysplastische Syndrome, β-Thalassämie

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indication: the indication in the wording of the decision, the date the status was granted and, where the status was withdrawn, the withdrawal date.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.

One row per orphan indication, exactly as Swissmedic publishes it.
Orphan indicationDiseaseStatus grantedStatus withdrawn
Behandlung der β-Thalassämie (Intermediäre und Major-Form)Beta thalassaemia11/07/2019Status active
Behandlung der myelodysplastischen SyndromeMyelodysplastic syndromes (MDS)13/06/2019Status 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.

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Frequently asked questions

Is Reblozyl authorised in Switzerland?

Yes. Reblozyl is authorised by Swissmedic under number 69592, first authorised on 21/05/2026. The product also carries orphan drug status for a rare disease.

What does orphan drug status mean for Reblozyl?

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 Reblozyl 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.

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