EMA Authorised: Koselugo (selumetinib sulfate) — AstraZeneca AB

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Summary

Koselugo (selumetinib sulfate) has been authorised by the EMA for Neurofibromatosis Type 1 under conditional approval as an orphan medicine.

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Diseases / indications

• Neurofibromatosis Type

Drugs mentioned

• Koselugo (selumetinib)

Snippet

Status: Authorised. Therapeutic area: Neurofibromatosis 1. MAH: AstraZeneca AB. Decision date: 09/01/2026. Conditional approval. Orphan medicine