EMA Authorised: Hyftor (sirolimus) — Plusultra pharma GmbH

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Summary

Sirolimus (Hyftor) from Plusultra pharma GmbH has been authorised for use in angiofibroma and tuberous sclerosis, designated as an orphan medicine in the EU.

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Diseases / indications

• Angiofibroma
• Tuberous Sclerosis

Drugs mentioned

• Hyftor (sirolimus)

Snippet

Status: Authorised. Therapeutic area: Angiofibroma;Tuberous Sclerosis. MAH: Plusultra pharma GmbH. Decision date: 04/07/2025. Orphan medicine