Zolvix

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Withdrawal statement

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.

Name Language First published Last updated
Withdrawal assessment report for Zolvix: Extension (new target species) (English only) 2013-01-25  

Key facts

Product details for Zolvix
NameZolvix
INN or common name

monepantel

Active substancemonepantel
Date of withdrawal19/10/2012
Company making the application

Elanco Europe Ltd

Withdrawal typePost-authorisation

All documents

Name Language First published Last updated
Withdrawal letter: Zolvix (English only) 2013-01-24  
Withdrawal assessment report for Zolvix: Extension (new target species) (English only) 2013-01-25  

News

Related information

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An assessment report is published when the application is withdrawn after the first stage of the CVMP's evaluation is completed ('day 120').