This is a summary of the European public assessment report (EPAR) for Bronchitol. 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 Bronchitol.
Bronchitol : EPAR - Summary for the public (PDF/58.13 KB)
First published: 02/08/2012
Last updated: 02/08/2012
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Pharmaxis Europe Limited
|Date of issue of marketing authorisation valid throughout the European Union||
23/01/2019 Bronchitol - EMEA/H/C/001252 - T/0035
- 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
Please note that the size of the above document can exceed 50 pages.
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Bronchitol is indicated for the treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care.