Enerzair Breezhaler

indacaterol / glycopyrronium / mometasone furoate

Table of contents

Opinion

On 30 April 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Enerzair Breezhaler, for maintenance treatment of asthma in adults whose disease is not adequately controlled. The applicant for this medicinal product is Novartis Europharm Limited.

Enerzair Breezhaler will be available as a 114 µg / 46 µg / 136 µg inhalation powder in hard capsules. The active substances of Enerzair Breezhaler are indacaterol, glycopyrronium and mometasone. Indacaterol is a long‑acting beta2‑adrenergic agonist (LABA), which relaxes bronchial smooth muscle; glycopyrronium is a long‑acting muscarinic receptor antagonist (LAMA), which dilates the airways by blocking cholinergic bronchoconstrictor action; and mometasone is a synthetic corticosteroid with anti-inflammatory activity.

The benefits with Enerzair Breezhaler are its ability to improve lung function as measured by FEV1 and to reduce exacerbations of asthma.

The most common side effects are asthma (exacerbation), nasopharyngitis, upper respiratory tract infection and headache.

The full indication is:

Enerzair Breezhaler is indicated as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long‑acting beta2‑agonist and a high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Key facts

Name
Enerzair Breezhaler
Agency product number
EMEA/H/C/005061
International non-proprietary name (INN) or common name
  • indacaterol
  • glycopyrronium
  • mometasone furoate
Active substance
  • Glycopyrronium bromide
  • indacaterol acetate
  • Mometasone furoate
Therapeutic area
Asthma
Date opinion adopted
30/04/2020
Company name
Novartis Europharm Limited
Status
Positive
Application type
Initial authorisation

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