Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Colobreathe   
Auth. number : EU/1/11/747
Active substance : Colistimethate sodium
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J01 - Antibacterials for systemic use
Pharmacological subgroup: J01X - Other antibacterials
Chemical subgroup: J01XB - Polymyxins
Chemical substance: J01XB01 - Colistin
(See WHO ATC Index)
Indication: Indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged 6 years and older.Consideration should be given to official guidance on the appropriate use of antibacterial active substances.
Marketing Authorisation Holder: Teva B.V.
Swensweg 5, 2031 GA Haarlem, Nederland
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
15/02/2012 Centralised - Authorisation EMEA/H/C/1225 (2012)1042 of 13/02/2012
21/02/2012 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/1225 (2012)1176 of 17/02/2012
26/06/2012 Centralised - Notification EMEA/H/C/1225/N/1
Updated with Decision(2014)5623 of 31/07/2014
02/08/2013 Centralised - Variation EMEA/H/C/1225/IB/3
Updated with Decision(2014)5623 of 31/07/2014
05/08/2013 Centralised - Variation EMEA/H/C/1225/IA/6
Updated with Decision(2014)5623 of 31/07/2014
21/11/2013 Centralised - Variation EMEA/H/C/1225/II/5
Updated with Decision(2014)5623 of 31/07/2014
08/01/2014 Centralised - Variation EMEA/H/C/1225/IA/12
Updated with Decision(2014)5623 of 31/07/2014
04/08/2014 Centralised - Yearly update (2014)5623 of 31/07/2014
25/09/2014 Centralised - Variation EMEA/H/C/1225/II/15
Updated with Decision(2015)1746 of 11/03/2015
28/11/2014 Centralised - Variation EMEA/H/C/1225/IA/17
Updated with Decision(2015)8299 of 19/11/2015
13/03/2015 Referral EMEA/H/C/1225/A-31 (2015)1746 of 11/03/2015
12/06/2015 Centralised - Variation EMEA/H/C/1225/IAin/20
Updated with Decision(2015)8299 of 19/11/2015
23/11/2015 Centralised - Yearly update (2015)8299 of 19/11/2015
28/09/2016 Centralised - Renewal EMEA/H/C/1225/R/24 (2016)6294 of 26/09/2016
14/12/2016 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1225/T/28 (2016)8664 of 12/12/2016
23/02/2017 Centralised - Variation EMEA/H/C/1225/II/23