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EMA approval · 2025-07-25

EMA Authorised: Xoterna Breezhaler (indacaterol;glycopyrronium bromide) — Novartis Europharm Limited

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Summary

EMA authorized Xoterna Breezhaler, a fixed-dose inhalation combination of indacaterol and glycopyrronium bromide, for chronic obstructive pulmonary disease, by …

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Diseases / indications

Drugs mentioned

  • Xoterna Breezhaler (indacaterol; glycopyrronium bromide)

Snippet

Status: Authorised. Therapeutic area: Pulmonary Disease, Chronic Obstructive. MAH: Novartis Europharm Limited. Decision date: 24/07/2025