Tovanor Breezhaler
glycopyrronium bromide
Table of contents
Overview
Tovanor 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. Tovanor Breezhaler is used for maintenance (regular) treatment.
Tovanor Breezhaler contains the active substance glycopyrronium bromide.
Authorisation details
Product details | |
---|---|
Name |
Tovanor Breezhaler
|
Agency product number |
EMEA/H/C/002690
|
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
|
Publication details | |
---|---|
Marketing-authorisation holder |
Novartis Europharm Limited
|
Revision |
15
|
Date of issue of marketing authorisation valid throughout the European Union |
28/09/2012
|
Contact address |
Vista Building |
Product information
28/10/2021 Tovanor Breezhaler - EMEA/H/C/002690 - WS/2176
This medicine’s product information is available in all official EU languages.
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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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Drugs for obstructive airway diseases
Therapeutic indication
Tovanor Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).