EMA
withdrawal
· 2025-11-14
EMA Refused: Kizfizo (temozolomide) — ORPHELIA Pharma
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
Snippet
Status: Refused. Therapeutic area: Neuroblastoma. MAH: ORPHELIA Pharma. Decision date: 02/05/2025