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.
Overview
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
- Species
- Sheep
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QP52AX09
- Marketing authorisation holder
- Elanco GmbH
- Date of issue of marketing authorisation valid throughout the European Union
- Date of withdrawal
News on Zolvix
More information on Zolvix
This page was last updated on