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EMA withdrawal · 2008-01-24

EMA Refused: Mylotarg (gemtuzumab ozogamicin) — Wyeth Europa Ltd

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Summary

The EMA refused approval for Mylotarg (gemtuzumab ozogamicin) by Wyeth Europa Ltd for acute myeloid leukemia.

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Diseases / indications

Drugs mentioned

  • Mylotarg (gemtuzumab ozogamicin)

Snippet

Status: Refused. Therapeutic area: Leukemia, Myeloid, Acute. MAH: Wyeth Europa Ltd. Decision date: 24/01/2008. Orphan medicine