EMA Authorised: Azacitidine Mylan (azacitidine) — Mylan Pharmaceuticals Limited

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Summary

EU authorisation granted for Azacitidine Mylan for treatment of myelodysplastic syndromes and certain leukemias, expanding access to azacitidine in the EU.

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Diseases / indications

• Acute Myeloid Leukemia
• Myelodysplastic Syndromes
• Myelomonocytic Leukemia

Drugs mentioned

• Azacitidine Mylan (azacitidine)

Snippet

Status: Authorised. Therapeutic area: Myelodysplastic Syndromes;Leukemia, Myelomonocytic, Chronic;Leukemia, Myeloid, Acute. MAH: Mylan Pharmaceuticals Limited. Decision date: 12/12/2025