EMA Authorised: Mylotarg (gemtuzumab ozogamicin) — Pfizer Europe MA EEIG

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Summary

The EMA has authorized Mylotarg (gemtuzumab ozogamicin) for acute myeloid leukemia. The product carries orphan medicine designation.

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Diseases / indications

• Acute Myeloid Leukemia

Drugs mentioned

• Mylotarg (gemtuzumab ozogamicin)

Snippet

Status: Authorised. Therapeutic area: Leukemia, Myeloid, Acute. MAH: Pfizer Europe MA EEIG. Decision date: 11/09/2025. Orphan medicine