Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Reconcile   
Auth. number : EU/2/08/080
INN : Fluoxetine
ATC: Anatomical main group: QN - Nervous system
Therapeutic subgroup: QN06 - Psychoanaleptics
Pharmacological subgroup: QN06A - Antidepressants
Chemical subgroup: QN06AB - Selective serotonin reuptake inhibitors
Chemical substance: QN06AB03 - Fluoxetine
(See WHO ATCvet Index)
Indication: Aid in the treatment of separation-related disorders in dogs manifested by destruction and inappropriate behaviours(vocalisation and inappropriate defecation and/or urination) and only in combination with behavioural modification techniques.
Marketing Authorisation Holder: Eli Lilly and Company Ltd
Priestley Road, Basingstoke, Hampshire RG24 9NL, 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
16/07/2008 Centralised - Authorisation EMEA/V/C/133 (2008)3591 of 08/07/2008
17/10/2008 Centralised - Variation EMEA/V/C/133/II/1
25/06/2009 Centralised - Variation EMEA/V/C/133/II/2
21/12/2009 Centralised - Variation EMEA/V/C/133/II/3
28/04/2010 Centralised - Variation EMEA/V/C/133/IA/4
17/01/2011 Centralised - Variation EMEA/V/C/133/IAin/5
12/08/2011 Centralised - Variation EMEA/V/C/133/IB/6
Updated with Decision(2012)1382 of 27/02/2012
29/02/2012 Centralised - Variation (2012)1382 of 27/02/2012
19/07/2013 Centralised - Renewal EMEA/V/C/133/R/13 (2013)4626 of 15/07/2013