Summary of product characteristics for antiparasitic veterinary medicinal products

The aim of this guideline is to provide SPC guidance mainly in relation to antiparasitic resistance. The guideline indicates which information and recommendations should be included in this respect in the different SPC sections and proposes standard text where appropriate.

This is the first revision of the Guideline on the summary of product characteristics for anthelmintics (EMEA/CVMP/EWP/170208/2005), which initially came into effect in February 2008. The main aim of the revision is to take into account the evolution of antiparasitic resistance in the EU and the scientific knowledge on the factors that significantly influence resistance development..

Keywords: antiparasitic, anthelmintic, ectoparasiticide, resistance, veterinary, SPC, product information

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