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The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Novartis Animal Health Australasia Pty Ltd for registration of a new product, Zolvix Monepantel Broad Spectrum Oral Anthelmintic for Sheep, containing the new active constituent monepantel. This publication provides a summary of the data assessed and an outline of the regulatory considerations for the proposed registration of Zolvix Monepantel Broad Spectrum Oral Anthelmintic for Sheep.