Reconcile
fluoxetine
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Reconcile. It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Reconcile.
For practical information about using Reconcile, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Authorisation details
Product details | |
---|---|
Name |
Reconcile
|
Agency product number |
EMEA/V/C/000133
|
Active substance |
fluoxetine
|
International non-proprietary name (INN) or common name |
fluoxetine
|
Species |
Dogs
|
Anatomical therapeutic chemical veterinary (ATCvet) codes |
QN06AB03
|
Publication details | |
---|---|
Marketing-authorisation holder |
Pegasus Laboratories Ireland Limited
|
Revision |
12
|
Date of issue of marketing authorisation valid throughout the European Union |
08/07/2008
|
Contact address |
Product information
17/04/2020 Reconcile - EMEA/V/C/000133 - IA/0034/G
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Psychoanaleptics
Therapeutic indication
As an 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.