Table of contents
This is a summary of the European public assessment report (EPAR) for Colobreathe. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Colobreathe.
Colobreathe : EPAR - Summary for the public (PDF/71.3 KB)
First published: 07/03/2012
Last updated: 07/03/2012
Colobreathe : EPAR - Risk-management-plan-summary (PDF/66.2 KB)
First published: 18/03/2020
Last updated: 13/01/2022
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
|Date of issue of marketing authorisation valid throughout the European Union||
10/05/2023 Colobreathe - EMEA/H/C/001225 - IA/0055
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).
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.
Antibacterials for systemic use
Colobreathe is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged six years and older.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.