Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Bronchitol   
Auth. number : EU/1/12/760
Active substance : Mannitol
Orphan market exclusivity for "Treatment of cystic fibrosis" (based on designation EU/3/05/325) started on 18/04/2012
   10 years of market exclusivity
   This orphan market exclusivity will expire on 18/04/2022
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
25 Moorgate, London, EC2R 6AY, 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 EMEA/H/C/1252 (2012)2534 of 13/04/2012
18/04/2012 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/1252 (2012)2535 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 - Notification 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
Updated with Decision(2014)9825 of 11/12/2014
23/12/2013 Centralised - Yearly update (2013)9720 of 18/12/2013
17/07/2014 Centralised - Variation EMEA/H/C/1252/IA/13
Updated with Decision(2014)9825 of 11/12/2014
15/12/2014 Centralised - Yearly update (2014)9825 of 11/12/2014
23/04/2015 Centralised - Variation EMEA/H/C/1252/II/16/G
Updated with Decision(2016)245 of 14/01/2016
16/07/2015 Centralised - Variation EMEA/H/C/1252/IAIN/17/G
Updated with Decision(2016)245 of 14/01/2016
18/01/2016 PSUSA - Modification EMEA/H/C/1252/PSUSA/9226/201504 (2016)245 of 14/01/2016
29/03/2016 Centralised - Variation EMEA/H/C/1252/IB/21
Updated with Decision(2017) 188 of 11/01/2017
18/04/2016 Centralised - Notification EMEA/H/C/1252/N/24
Updated with Decision(2017) 188 of 11/01/2017
15/12/2016 Centralised - Variation EMEA/H/C/1252/II/27
13/01/2017 Centralised - Renewal EMEA/H/C/1252/R/28 (2017) 188 of 11/01/2017
02/06/2017 Centralised - Notification EMEA/H/C/1252/N/29