EMA Authorised: Omlyclo (omalizumab) — Celltrion Healthcare Hungary Kft.

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Summary

EMA has authorised Omlyclo (omalizumab) by Celltrion Healthcare Hungary Kft. for asthma and urticaria.

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Diseases / indications

• Asthma
• Urticaria

Drugs mentioned

• Omlyclo® (omalizumab biosimilar)

Snippet

Status: Authorised. Therapeutic area: Asthma;Urticaria. MAH: Celltrion Healthcare Hungary Kft.. Decision date: 10/11/2025