Spevigo Authorization Transfer to LEO, Delayed Leaflet
Summary
Swissmedic notifies healthcare professionals that the marketing authorization for Spevigo (spesolimabum, authorization no. 68625) was transferred from Boehringer Ingelheim (Schweiz) GmbH to LEO Pharmaceutical Products Sarath Ltd. effective 02.03.2026. To prevent supply disruption, packages with outdated package leaflets remain in circulation until the reprint is completed. These leaflets have not yet been updated with the latest approved safety information.
What changed
The marketing authorization for Spevigo was transferred from Boehringer Ingelheim to LEO Pharmaceutical Products Sarath Ltd. on 02.03.2026. Swissmedic issued this communication on 15.04.2026 to notify healthcare professionals that existing product stock in circulation may contain package leaflets that have not been updated with the latest approved safety information due to a delay in reprinting.
Healthcare providers and pharmacies should be aware that current stock may not reflect the most recent safety information approved for Spevigo. They should consult the LEO Pharmaceutical information letter for current prescribing information and any updated safety guidance before administering the medication.
What to do next
- Consult the LEO Pharma information letter for updated safety information
- Verify current prescribing information before administering Spevigo
Archived snapshot
Apr 16, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
DHPC – Spevigo® (spesolimabum)
Verzögerter Neudruck der zuletzt genehmigten Packungsbeilage aufgrund der Übertragung der Zulassung
15.04.2026
| Präparat | Spevigo, Konzentrat zur Herstellung einer Infusionslösung |
|---|---|
| Zulassungsnummer | 68625 |
| Wirkstoff | spesolimabum |
| Zulassungsinhaberin | LEO Pharmaceutical Products Sarath Ltd. |
Am 02.03.2026 wurde die Zulassung bei Spevigo von Boehringer Ingelheim (Schweiz) GmbH auf LEO Pharmaceutical Products Sarath Ltd. übertragen. Um eine Unterbrechung der Marktversorgung zu vermeiden, werden bis zum Neudruck noch Packungen mit den bisherigen Packungsbeilagen vertrieben. Diese Packungsbeilagen enthalten noch nicht die neuesten genehmigten Sicherheitsinformationen.
Weitere Informationen entnehmen Sie bitte dem Informationsschreiben der Firma.
- Company information letter
DHPC – Spevigo® (spesolimabum) (PDF, 650 kB, 15.04.2026)
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