Velactis

Withdrawn

This medicine's authorisation has been withdrawn

cabergoline

Overview

  The marketing authorisation for this product has not been renewed by the marketing authorisation holder and is now withdrawn. 

Velactis : EPAR - Summary for the public

Reference Number: EMA/669530/2015

Product information

Velactis : EPAR - Product Information

Velactis : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Velactis
• Active substance:
  cabergoline
• International non-proprietary name (INN) or common name:
  cabergoline
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QG02CB03

Pharmacotherapeutic group

• Genito urinary system and sex hormones
• Other gynecologicals
• Prolactine inhibitors

Therapeutic indication

For use in the herd management programme of dairy cows as an aid in the abrupt drying-off by reducing milk production to:

• reduce milk leakage at drying off;
• reduce the risk of new intramammary infections during the dry period;
• reduce discomfort.

Authorisation details

• EMA product number:
  EMEA/V/C/003739
• Marketing authorisation holder:
  Ceva Santé Animale

  10 Avenue de la Ballastiere ; 33500 Libourne ; France

• Marketing authorisation issued:
  09/12/2015
• Revision:
  1

Assessment history

Changes since initial authorisation of medicine

Velactis : EPAR - Procedural steps taken and scientific information after authorisation

CVMP post-authorisation summary of negative opinion for Velactis (II/0004)

Adopted Reference Number: EMA/CVMP/633397/2019

Velactis : EPAR - Annex to the Opinion of the Committee for Medicinal Products for Veterinary Use pursuant to Article 45 of Regulation EC No 726 2004 for Velactis

Initial marketing authorisation documents

Velactis : EPAR - Public assessment report

Adopted Reference Number: EMA/673468/2015

CVMP summary of positive opinion for Velactis

Adopted Reference Number: EMA/CVMP/484406/2015