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EMA approval · 2026-01-28

EMA Authorised: Koselugo (selumetinib sulfate) — AstraZeneca AB

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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

  • Koselugo (selumetinib)

Snippet

Status: Authorised. Therapeutic area: Neurofibromatosis 1. MAH: AstraZeneca AB. Decision date: 24/10/2025. Conditional approval. Orphan medicine