Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Posatex   
Auth. number : EU/2/08/081
Active substance : Orbifloxacin, Mometasone furoate, Posaconazole
ATC: Anatomical main group: QS - Sensory organs
Therapeutic subgroup: QS02 - Otologicals
Pharmacological subgroup: QS02C - Corticosteroids and antiinfectives in combination
Chemical subgroup: QS02CA - Corticosteroids and antiinfectives in combination
Chemical substance: QS02CA91 - Mometasone and antiinfectives
(See WHO ATCvet Index)
Indication: Treatment of acute otitis externa and acute exacerbations of recurrent otitis externa, associated with bacteria susceptible to orbifloxacin and fungi susceptible to posaconazole, in particular Malassezia pachydermatis
Marketing Authorisation Holder: Intervet International B.V.
Wim de Körverstraat 35, NL-5831 AN Boxmeer, 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
25/06/2008 Centralised - Authorisation EMEA/V/C/122 (2008)3231 of 23/06/2008
13/03/2009 Centralised - Variation (no change in Commission Decision) EMEA/V/C/122/IB/1
02/07/2009 Centralised - Transfer Marketing Authorisation Holder EMEA/V/C/122/T/3 (2009)5393 of 30/06/2009
10/09/2009 Centralised - Variation EMEA/V/C/122/II/2 (2009)6928 of 08/09/2009
22/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/V/C/122/IB/4
31/03/2010 Centralised - Variation EMEA/V/C/122/IB/5/G
Updated with Decision(2010)7211 of 14/10/2010
14/07/2010 Centralised - Variation EMEA/V/C/122/IB/7
Updated with Decision(2010)7211 of 14/10/2010
23/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/V/C/122/IB/6/G
18/10/2010 Centralised - Variation (2010)7211 of 14/10/2010
25/11/2010 Centralised - Variation EMEA/V/C/122/IA/9/G
Updated with Decision(2011)5382 of 20/07/2011
07/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/V/C/122/IB/8
14/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/V/C/122/IA/10/G
25/07/2011 Centralised - Variation (2011)5382 of 20/07/2011
24/01/2012 Centralised - Variation EMEA/V/C/122/II/12 (2012)411 of 20/01/2012
11/10/2012 Centralised - Variation EMEA/V/C/122/IB/16
Updated with Decision(2012)7706 of 25/10/2012
29/10/2012 Centralised - Variation (2012)7706 of 25/10/2012
16/05/2013 Centralised - Renewal EMEA/V/C/122/R/18 (2013)2903 of 14/05/2013