Zolvix - withdrawal of application for variation to marketing authorisation

Application withdrawn

The application for a change to this medicine's authorisation has been withdrawn

monepantel

Overview

On 27 February 2012, Novartis Santé Animale S.A.S. submitted an application for the extension of the Community marketing authorisation to add goats as target species to Zolvix 25-mg/ml oral solution, in accordance with Commission Regulation (EC) No. 1234/2008.On 19 October 2012, Novartis Animal Health withdrew the application at day 190 of the procedure on the basis of the Committee for Medicinal Products for Veterinary Use (CVMP) not supporting all of the proposed indications.

Key facts

• Name of medicine:
  Zolvix
• EMA product number:
  EMEA/V/C/000154
• Active substance:
  monepantel
• International non-proprietary name (INN) or common name:
  monepantel
• Date of withdrawal:
  19/10/2012

Documents

Withdrawal letter: Zolvix

Withdrawal assessment report for Zolvix: Extension (new target species)

Reference Number: EMA/794474/2012