Zolvix: Withdrawal of the application to change the marketing authorisation

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
Zolvix
Product number
EMEA/V/C/000154
Date of issue of market authorisation valid throughout the European Union (if applicable)
04/11/2009
International non-proprietary name (INN) or common name
  • monepantel
Active substance
  • monepantel
Date of withdrawal
19/10/2012
Company making the application
Elanco Europe Ltd
Withdrawal type
Post-authorisation

Related content

Related information on withdrawals

The question-and-answer (Q&A) document provides a summary of the CVMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter. An assessment report is published when the application is withdrawn after the first stage of the CVMP's evaluation is completed ('day 120').

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