EMA
approval
· 2026-01-28
EMA Authorised: Koselugo (selumetinib sulfate) — AstraZeneca AB
Summary
The EMA authorized Koselugo (selumetinib) for Neurofibromatosis type 1 with conditional approval and orphan medicine designation. This represents an EU-approved…
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Diseases / indications
Drugs mentioned
Snippet
Status: Authorised. Therapeutic area: Neurofibromatosis 1. MAH: AstraZeneca AB. Decision date: 24/10/2025. Conditional approval. Orphan medicine