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
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28/08/2019 Colobreathe - EMEA/H/C/001225 - IAIN/0043
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.