Bronchitol

RSS

mannitol

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 05/04/2019

Authorisation details

Product details
Name
Bronchitol
Agency product number
EMEA/H/C/001252
Active substance
mannitol
International non-proprietary name (INN) or common name
mannitol
Therapeutic area (MeSH)
Cystic Fibrosis
Anatomical therapeutic chemical (ATC) code
R05CB16
OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Pharmaxis Europe Limited
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
13/04/2012
Contact address

108 Q House
Furze Road
Sandyford
Dublin 18, D18AY29 
Ireland

Product information

23/01/2019 Bronchitol - EMEA/H/C/001252 - T/0035

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

COUGH AND COLD PREPARATIONS

Therapeutic indication

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.

Assessment history

How useful was this page?

Add your rating
Average
1 rating