Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Bronchitol   
Auth. number : EU/1/12/760
INN : Mannitol
Orphan status based on designation EU/3/05/325 added on 18/04/2012
ATC: Anatomical main group: R - Respiratory system
Therapeutic subgroup: R05 - Cough and cold preparations
Pharmacological subgroup: R05C - Expectorants, excluding combinations with antitussives
Chemical subgroup: R05CB - Mucolytics
Chemical substance: R05CB16 - Mannitol
(See WHO ATC Index)
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.
Marketing Authorisation Holder: Pharmaxis Pharmaceuticals Limited
The Priory, Stomp Road, Burnham, Buckinghamshire SL1 7LW, United Kingdom

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
18/04/2012 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/1252 (2012)2535 of 13/04/2012
18/04/2012 Centralised - Authorisation EMEA/H/C/1252 (2012)2534 of 13/04/2012
08/06/2012 Centralised - Variation EMEA/H/C/1252/IAin/1
Updated with Decision(2012)7896 of 29/10/2012
01/11/2012 Centralised - Variation (2012)7896 of 29/10/2012
12/12/2012 Centralised - Variation EMEA/H/C/1252/IB/4
Updated with Decision(2013)9720 of 18/12/2013
06/11/2013 Centralised - Variation EMEA/H/C/1252/N/8
Updated with Decision(2013)9720 of 18/12/2013
19/12/2013 Centralised - Variation EMEA/H/C/1252/IA/9
23/12/2013 Centralised - Variation (2013)9720 of 18/12/2013
17/07/2014 Centralised - Variation EMEA/H/C/1252/IA/13