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EMA Product

Zimbus Breezhaler

Product approved by European Medicines Agency (EU)

Basic Information

Zimbus Breezhaler

Regulatory Information

EMEA/H/C/005518

Authorised

July 3, 2020

April 30, 2020

7

November 27, 2024

Company Information

Ireland

Vista Building Elm Park Merrion Road Dublin 4

NOVARTIS EUROPHARM LIMITED

Active Substances Detail

Glycopyrronium bromideIndacaterol (acetate)Mometasone furoate

Detailed Information

Therapeutic Indication

### Therapeutic indication Maintenance treatment of asthma in adults whose disease is not adequately controlled.

Overview Summary

Zimbus Breezhaler is an asthma medicine for inhalation. It is used for maintenance (regular) treatment in adults whose asthma is not controlled well enough with inhaled long-acting beta-2 agonist together with a high dose of an inhaled corticosteroid. It should be used for patients who have had at least one asthma attack (exacerbations) in the last year. Zimbus Breezhaler contains the active substances indacaterol, glycopyrronium bromide and mometasone.

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