Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Cayston   
Auth. number : EU/1/09/543
INN : aztreonam
Orphan status based on designation EU/3/04/204 added on 23/09/2009
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J01 - Antibacterials for systemic use
Pharmacological subgroup: J01D - Other beta-lactam antibacterials
Chemical subgroup: J01DF - Monobactams
Chemical substance: J01DF01 - Aztreonam
(See WHO ATC Index)
Indication: Cayston is indicated for the suppressive therapy 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 agents.
Marketing Authorisation Holder: Gilead Sciences International Limited
Granta Park, Abington, Cambridge CB21 6GT, 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 continues to be 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
23/09/2009 Centralised - Authorisation EMEA/H/C/996 (2009)7407 of 21/09/2009
27/10/2009 Centralised - Variation EMEA/H/C/996/IB/1
Updated with Decision(2010)1825 of 15/03/2010
01/02/2010 Centralised - Variation EMEA/H/C/996/IB/2
04/03/2010 Centralised - Variation EMEA/H/C/996/II/3
04/03/2010 Centralised - Variation EMEA/H/C/996/IA/5
Updated with Decision(2010)5996 of 26/08/2010
12/03/2010 Centralised - Variation EMEA/H/C/996/IB/4
17/03/2010 Centralised - Variation (2010)1825 of 15/03/2010
12/05/2010 Centralised - Variation EMEA/H/C/996/IA/7
12/07/2010 Centralised - Variation EMEA/H/C/996/IA/8
Updated with Decision(2011)2102 of 24/03/2011
23/07/2010 Centralised - Variation EMEA/H/C/996/IA/9
31/08/2010 Centralised - Annual renewal EMEA/H/C/996/R/6 (2010)5996 of 26/08/2010
25/11/2010 Centralised - Variation EMEA/H/C/996/IA/11
25/11/2010 Centralised - Variation EMEA/H/C/996/IB/10
Updated with Decision(2011)2102 of 24/03/2011
22/12/2010 Centralised - Variation EMEA/H/C/996/IB/12
06/01/2011 Centralised - Variation EMEA/H/C/996/IB/13
Updated with Decision(2011)2102 of 24/03/2011
18/01/2011 Centralised - Variation EMEA/H/C/996/IB/14/G
24/03/2011 Centralised - Variation EMEA/H/C/996/IG/47
29/03/2011 Centralised - Variation (2011)2102 of 24/03/2011
07/09/2011 Centralised - Authorisation - Switch to non-conditional EMEA/H/C/996/R/15 (2011)6378 of 05/09/2011
23/03/2012 Centralised - Variation EMEA/H/C/996/IB/27
Updated with Decision(2012)5345 of 23/07/2012
01/06/2012 Referral EMEA/H/C/996/A-20/24 (2012)3614 of 25/05/2012
25/07/2012 Centralised - Variation EMEA/H/C/996/II/18, 26 (2012)5345 of 23/07/2012
07/12/2012 Centralised - Variation EMEA/H/C/996/N/32