SPECIAL PRECAUTIONS FOR USE OF VETERINARY MEDICINAL PRODUCTS CONTAINING FLORFENICOL – NUFLOR 300 SOLUTION FOR INJECTION FOR CATTLE AND SHEEP AND ITS GENERICS
During a recent variation on a marketing authorisation for a generic product of the already authorized veterinary medicinal product (VMP) “NUFLOR 300 solution for injection for cattle and sheep” a potential serious risk for the environment was identified. Consequently, the EU network decided to add warning sentences concerning the precautions for the use of the VMP. The sentences were discussed between EU Member States involved in the procedure, the CMDv and also the Environmental Risk Assessment Working Party (ERA WP) at EMA. Indeed, the active substance contained in the VMP may pose a risk for terrestrial plants, cyanobacteria and groundwater organisms and as such, the VMP should not enter water courses.