Pharmaceuticals - Community Register


Community register of veterinary medicinal products


Product information

Invented name: Easotic   

   This product is authorised under a different brand name in the EU in the following languages:
   - Изотик (BG)
Auth. number : EU/2/08/085
Active substance : Hydrocortisone aceponate, Miconazole (as nitrate form), Gentamicin (as sulphate form)
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: QS02CA03 - hydrocortisone and antiinfectives
(See WHO ATCvet Index)
Indication: Treatment of acute otitis externa, and acute exacerbation of recurrent otitis externa associated with bacteria susceptible to gentamicin and fungi susceptible to miconazole in particular Malassezia pachydermatis.
Marketing Authorisation Holder: VIRBAC S.A.
1ère Avenue - 2065 m - L.I.D., 06516 Carros CEDEX, France
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
24/11/2008 Centralised - Authorisation EMEA/V/C/140 (2008)7428 of 20/11/2008
23/04/2009 Centralised - Variation EMEA/V/C/140/IB/1
Updated with Decision(2009)8604 of 30/10/2009
4/11/2009 Centralised - Variation (2009)8604 of 30/10/2009
14/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/V/C/140/IA/2
6/03/2012 Centralised - Variation EMEA/V/C/140/II/3/G (2012)1496 of 2/03/2012
13/11/2013 Centralised - Renewal EMEA/V/C/140/R/5 (2013)7952 of 11/11/2013
11/12/2014 Centralised - Variation EMEA/V/C/140/II/6/G
Updated with Decision(2015)8811 of 02/12/2015
4/12/2015 Centralised - Yearly update (2015)8811 of 2/12/2015
21/12/2016 Centralised - Variation EMEA/V/C/140/IG/724
Updated with Decision(2017)9112 of 20/12/2017
6/10/2017 Centralised - Notification EMEA/V/C/140/IB/10
Updated with Decision(2017)9112 of 20/12/2017
22/12/2017 Centralised - Yearly update (2017)9112 of 20/12/2017