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EMA approval · 2025-12-08

EMA Authorised: Scemblix (asciminib hydrochloride) — Novartis Europharm Limited

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Summary

The European Medicines Agency authorised Scemblix (asciminib hydrochloride) for chronic myeloid leukemia (BCR-ABL positive) and granted orphan designation to th…

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Diseases / indications

Drugs mentioned

  • SCEMBLIX (ASCIMINIB)

Snippet

Status: Authorised. Therapeutic area: Leukemia, Myelogenous, Chronic, BCR-ABL Positive. MAH: Novartis Europharm Limited. Decision date: 17/11/2025. Orphan medicine