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EMA withdrawal · 2025-11-14

EMA Refused: Kizfizo (temozolomide) — ORPHELIA Pharma

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Summary

The EMA refused marketing authorization for Kizfizo (temozolomide) for neuroblastoma, in an application from ORPHELIA Pharma.

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Diseases / indications

Drugs mentioned

  • Kizfizo (temozolomide)

Snippet

Status: Refused. Therapeutic area: Neuroblastoma. MAH: ORPHELIA Pharma. Decision date: 02/05/2025