Seebri Breezhaler
Authorised
This medicine is authorised for use in the European Union
glycopyrronium bromide
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Seebri Breezhaler is a medicine that is used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults. COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing. Seebri Breezhaler is used for maintenance (regular) treatment.
Seebri Breezhaler contains the active substance glycopyrronium bromide.
Seebri Breezhaler capsules, which contain a powder for inhalation, are only used with the Seebri Breezhaler inhaler and must not be swallowed. To take a dose, the patient places a capsule into the inhaler and breathes in through the mouth the powder from the capsule.
The recommended dose is one capsule once a day at the same time each day. Patients should not use more than one capsule in a day.
Seebri Breezhaler can only be obtained with a prescription.
For more information about using Seebri Breezhaler, see the package leaflet or contact your doctor or pharmacist.
The active substance in Seebri Breezhaler, glycopyrronium bromide, is a muscarinic receptor antagonist. This means that it widens the airways by blocking muscarinic receptors (targets) in muscle cells in the lungs. Muscarinic receptors control the contraction of muscles and when glycopyrronium bromide is inhaled, it relaxes the muscles of the airways. This helps to keep the airways open and allows the patient to breathe more easily.
Seebri Breezhaler was found to be more effective than placebo (a dummy treatment) at relieving symptoms of COPD in two main studies involving a total of 1,888 patients with COPD. In both studies, the main measure of effectiveness was improvement in patients’ forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
After 12 weeks of treatment, Seebri Breezhaler increased FEV1by 97 ml more than with placebo in the first study, and by 108 ml more in the second study.
The most common side effects with Seebri Breezhaler (seen in more than 1 patient in 100) are dry mouth, nasopharyngitis (inflammation of the nose and throat), insomnia (difficulty sleeping), muscle and bone pain and gastroenteritis (diarrhoea and vomiting). For the full list of all side effects and restrictions with Seebri Breezhaler, see the package leaflet.
The European Medicines Agency noted that Seebri Breezhaler had a modest but relevant benefit for patients in terms of improving lung function, and also improved the symptoms of COPD. The Agency also noted that the fact that the medicine is used once a day may help patients to adhere to their treatment. In addition, there were no major safety concerns with Seebri Breezhaler, with side effects similar to other muscarinic receptor antagonist medicines. Therefore, the Agency decided that Seebri 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 Seebri Breezhaler have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Seebri Breezhaler are continuously monitored. Side effects reported with Seebri Breezhaler are carefully evaluated and any necessary action taken to protect patients.
A Seebri Breezhaler : EPAR - Risk-management-plan summary is available.
Seebri Breezhaler received a marketing authorisation valid throughout the EU for Seebri Breezhaler on 28 September 2012.
For more information about treatment with Seebri Breezhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information:
WS/2176
28/10/2021
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 authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Seebri Breezhaler
- Active substance
- Glycopyrronium bromide
- International non-proprietary name (INN) or common name
- glycopyrronium bromide
- Therapeutic area (MeSH)
- Pulmonary Disease, Chronic Obstructive
- Anatomical therapeutic chemical (ATC) code
- R03BB06
Pharmacotherapeutic group
Drugs for obstructive airway diseasesTherapeutic indication
Seebri Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Topics
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