Dossier requirements for anticancer medicinal products for dogs and cats - Scientific guideline
Table of contents
This document outlines the conditions and data requirements for the demonstration of quality, safety (user, target animal), efficacy and environmental impact of anticancer veterinary medicinal product used in dogs and cats.
Keywords: Veterinary medicinal product, medicine, dog, cat, oncology, anti-cancer drug.
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Guideline on dossier requirements for anticancer medicinal products for dogs and cats (PDF/224.61 KB)
Adopted
First published: 20/04/2009
Last updated: 20/04/2009
Legal effective date: 01/11/2009
EMEA/CVMP/28510/2008 -
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Overview of comments received on draft guideline on dossier requirements for anticancer medicinal products for dogs and cats (EMEA/CVMP/28510/2008-consultation) (PDF/182.36 KB)
First published: 20/04/2009
Last updated: 20/04/2009
EMEA/CVMP/512902/2008 -
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Draft guideline on dossier requirements for anticancer medicinal products for dogs and cats (consultation) (PDF/198.82 KB)
Draft: consultation closed
First published: 21/01/2008
Last updated: 21/01/2008
MEA/CVMP/28510/2008-CONSULTATION -
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Concept paper on dossier requirements for oncology products (PDF/33.43 KB)
First published: 15/06/2005
Last updated: 15/06/2005
EMEA/CVMP/EWP/79590/2005