Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Avamys   
Auth. number : EU/1/07/434
Active substance : Fluticasone furoate
ATC: Anatomical main group: R - Respiratory system
Therapeutic subgroup: R01 - Nasal preparations
Pharmacological subgroup: R01A - Nasal decongestants for topical use
Chemical subgroup: R01AD - Corticosteroids
Chemical substance: R01AD12 - Flucticasone furoate
(See WHO ATC Index)
Indication: Avamys is indicated for the treatment of the symptoms of allergic rhinitis
Marketing Authorisation Holder: Glaxo Group Ltd
980 Great West Road, Brentford, Middlesex, TW8 9GS, 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
16/01/2008 Centralised - Authorisation EMEA/H/C/770 (2008)153 of 11/01/2008
15/02/2008 Corrigendum (2008)153 of 13/02/2008
09/04/2009 Centralised - Variation EMEA/H/C/770/II/2 (2009)2876 of 07/04/2009
05/06/2009 Centralised - Variation EMEA/H/C/770/II/1 (2009)4417 of 02/06/2009
24/12/2009 Centralised - Variation EMEA/H/C/770/II/3 (2009)10698 of 21/12/2009
28/01/2010 Centralised - Variation EMEA/H/C/770/II/4 (2010)527 of 25/01/2010
01/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/770/IB/5
18/02/2010 Centralised - Variation EMEA/H/C/770/IB/6
Updated with Decision(2010)7216 of 14/10/2010
19/10/2010 Centralised - Variation (2010)7216 of 14/10/2010
19/01/2011 Centralised - Variation EMEA/H/C/770/IG/34/G
Updated with Decision(2011)6228 of 26/08/2011
31/08/2011 Centralised - Variation (2011)6228 of 26/08/2011
15/11/2011 Centralised - Variation EMEA/H/C/770/II/7/G (2011)8246 of 10/11/2011
19/03/2012 Centralised - Variation EMEA/H/C/770/II/10 (2012)1857 of 15/03/2012
24/07/2012 Centralised - Variation EMEA/H/C/770/II/11, 12 (2012)5284 of 20/07/2012
19/12/2012 Centralised - Renewal EMEA/H/C/770/R/14 (2012)9816 of 17/12/2012
18/04/2013 Centralised - Variation EMEA/H/C/770/IG/279
Updated with Decision(2014)2924 of 28/04/2014
18/06/2013 Centralised - Variation EMEA/H/C/770/IB/18/G
Updated with Decision(2014)2924 of 28/04/2014
22/08/2013 Centralised - Notification EMEA/H/C/770/N/19
Updated with Decision(2014)2924 of 28/04/2014
21/11/2013 Centralised - Variation EMEA/H/C/770/II/20
Updated with Decision(2014)2924 of 28/04/2014
30/04/2014 Centralised - Yearly update (2014)2924 of 28/04/2014
26/03/2015 Centralised - Variation EMEA/H/C/770/II/22