- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Enerzair 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 (exacerbation) in the last year.
Enerzair Breezhaler contains the active substances indacaterol, glycopyrronium bromide and mometasone.
Enerzair Breezhaler is available as capsules for use in the inhaler supplied with the medicine. The medicine can only be obtained with a prescription.
The Enerzair Breezhaler capsule is placed in the inhaler and the patient breathes in the powder through the mouth. The patient should inhale powder from one capsule once daily, at around the same time each day.
An electronic sensor is available for use with the medicine. When attached to the inhaler, it records the patient’s use of the inhaler and it can send the information to the patient’s smartphone or other mobile device. The sensor is optional and it is not needed for using the inhaler.
For more information about using Enerzair Breezhaler, see the package leaflet or contact your doctor or pharmacist.
The three active substances in Enerzair Breezhaler, indacaterol, glycopyrronium bromide and mometasone, have been in use in several inhaled medicines for treating patients with breathing disorders. They work in different ways to allow the patient to breathe more easily.
Indacaterol is a long-acting beta-2 adrenergic receptor agonist. It relaxes the muscle around the airways into the lungs by activating targets called beta-2 receptors in the muscle cells. This helps to keep the airways open.
Glycopyrronium bromide is a muscarinic receptor antagonist. It blocks muscarinic receptors in muscle cells in the airways. Because these receptors help control the contraction of the airway muscles, blocking them causes the muscles to relax, helping to keep the airways open.
Mometasone is a corticosteroid that has anti-inflammatory effects. It works in a similar way to corticosteroid hormones in the body, reducing the activity of the immune system (the body’s defences). Mometasone helps to keep the airways clear by blocking the release of substances, such as histamine, that are involved in inflammation and release of mucus in the airways.
A main study involved 3,092 patients whose asthma was not well controlled on a combination of a long-acting beta-2 agonist and a corticosteroid used by inhalation. Patients had had at least one asthma exacerbation in the previous year. The study measured the change in patients’ forced expiratory volume over 1 second (FEV1, the maximum volume of air they could breathe out in 1 second) just before their next dose was due.
After 26 weeks of treatment, FEV1 improved by 65ml more in patients treated with Enerzair Breezhaler than in patients using an inhaler containing equivalent doses of indacaterol and mometasone, two of the three active substances in Enerzair Breezhaler.
The most common side effects with Enerzair Breezhaler (which may affect more than 1 in 10 people) are worsening of asthma and nasopharyngitis (inflammation in the nose and throat). Other common side effects (which may affect up to 1 in 100 people) include upper respiratory tract infection (nose and throat infections) and headache.
For the full list of side effects and restrictions of Enerzair Breezhaler, see the package leaflet.
In patients whose asthma is not controlled well enough on a combination of an inhaled long-acting beta-2 agonist and high-dose corticosteroid and who have had an exacerbation in the previous year, the improvement in FEV1 with Enerzair Breezhaler was modest but considered to be clinically important. The side effects of Enerzair Breezhaler are similar to those of other inhaled medicines used for treating asthma.
The European Medicines Agency therefore decided that Enerzair Breezhaler’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Enerzair Breezhaler have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Enerzair Breezhaler are continuously monitored. Side effects reported with Enerzair Breezhaler are carefully evaluated and any necessary action taken to protect patients.
Enerzair Breezhaler received a marketing authorisation valid throughout the EU on 03 July 2020.
Enerzair Breezhaler : EPAR - Medicine overview
Reference Number: EMA/246032/2020
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Enerzair Breezhaler : EPAR - Risk-management-plan summary
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Product information
Enerzair Breezhaler : EPAR - Product information
English (EN) (699.34 KB - PDF)
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български (BG) (729.07 KB - PDF)
First published: 21/07/2020Last updated: 23/05/2024
español (ES) (698.6 KB - PDF)
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čeština (CS) (735.3 KB - PDF)
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dansk (DA) (683.11 KB - PDF)
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polski (PL) (738.13 KB - PDF)
First published: 21/07/2020Last updated: 23/05/2024
português (PT) (704.17 KB - PDF)
First published: 21/07/2020Last updated: 23/05/2024
română (RO) (725.4 KB - PDF)
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slovenčina (SK) (734.53 KB - PDF)
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slovenščina (SL) (714.62 KB - PDF)
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Latest procedure affecting product information: N/0023
21/05/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics(annex I);
- manufacturing authorisationholder responsible for batch release (annex IIA);
- conditions of themarketing authorisation(annex IIB);
- labelling(annex IIIA);
- package leaflet(annex IIIB).
Enerzair Breezhaler : EPAR - All authorised presentations
English (EN) (96.89 KB - PDF)
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español (ES) (96.94 KB - PDF)
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čeština (CS) (106.25 KB - PDF)
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dansk (DA) (98.12 KB - PDF)
First published: 21/07/2020
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eesti keel (ET) (95.52 KB - PDF)
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français (FR) (98.25 KB - PDF)
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íslenska (IS) (100.34 KB - PDF)
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italiano (IT) (97.64 KB - PDF)
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latviešu valoda (LV) (100.87 KB - PDF)
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lietuvių kalba (LT) (127.28 KB - PDF)
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Product details
- Name of medicine
Enerzair Breezhaler
- Active substance
- indacaterol
- Glycopyrronium bromide
- mometasone
- International non-proprietary name (INN) or common name
- indacaterol
- glycopyrronium bromide
- mometasone
- Therapeutic area (MeSH)
Asthma
- Anatomical therapeutic chemical (ATC) code
R03AL
Pharmacotherapeutic group
Drugs for obstructive airway diseases
Therapeutic indication
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.
Authorisation details
- EMA product number
EMEA/H/C/005061
- Marketing authorisation holder
Novartis Europharm Limited
Vista Building
Elm Park
Merrion Road
Dublin 4
Ireland- Opinion adopted
07/09/2023
- Marketing authorisation issued
03/07/2020
- Revision
7
Assessment history
Enerzair Breezhaler : EPAR - Procedural steps taken and scientific information after the authorisation
English (EN) (142.19 KB - PDF)
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Enerzair Breezhaler : EPAR - Public assessment report
AdoptedReference Number: EMA/271332/2020
English (EN) (5.93 MB - PDF)
First published:
CHMP summary of positive opinion for Enerzair Breezhaler
AdoptedReference Number: EMA/CHMP/64858/2020
English (EN) (111.18 KB - PDF)
First published:
News on Enerzair Breezhaler
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-30 April 2020
First triple combination therapy for asthma with optional electronic sensor
More information on Enerzair Breezhaler
- EMEA-001812-PIP01-15-M01 - paediatric investigation plan
Topics
Medicines
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