EMA approves 11 new veterinary medicines
EMA recommended 11 new veterinary medicines for marketing authorisations in 2016.
The European Medicines Agency (EMA) has published highlights from its recommendations for veterinary medicines in 2016, which includes marketing authorisations for 11 new products.
The following medicines were recommended for marketing authorisations:
- VarroMed: an anti-parasitic medicine to treat Varroa mite infestation in honey bee colonies, which is thought to be the most significant parasitic health concern facing honey bees globally.
- Evalon: a vaccine that protects chickens against coccidiosis, a parasitic disease of the intestinal tract.
- CLYNAV: a biotechnological vaccine that protects Atlantic salmon from pancreas disease, caused by infection with salmonid alphavirus subtype 3.
- Coliprotec F4/F18: a vaccine to protect against porcine post-weaning diarrhoea caused by E. coli in pigs.
- Eravac: a vaccine to protect rabbits against a new variant of rabbit haemorrhagic disease virus (RHDV2).
- Letifend: a biotechnological vaccine for dogs to protect them from leishmaniasis.
Other new medicines include HALAGON for newborn calves, Cepedex, Sedadex and Sevohale for dogs, and Cepedex, Sedadex and Stronghold plus for cats.
Six medicines contain a new active substance: Coliprotec F4/F18, CLYNAV, Eravac, VarroMed, Letifend and Stronghold plus.
The use of four known substances was also expanded in 2016. DRAXXIN can be used against swine respiratory disease, Profender can be used as a spot-on solution for cats, Poulvac E. Coli can also be used in turkeys and Trifexis can be used to treat and prevent flea infestations in dogs.
EMA made a number of CVMP recommendations in 2016: to increase the withdrawal period for medicines containing gentamicin in cattle and pigs to enhance consumer safety; and to avoid administering gentamicin subcutaneously.
Environment protection measures should be taken to ensure altrenogest - a steroidal hormone used to treat young female pigs and mares - has no adverse effects on reproduction for aquatic organisms.
Medicines containing zinc oxide, used in medicated feeding stuff for piglets, were withdrawn and marketing authorisations refused, as these are considered harmful to the environment. Velactis was also suspended after serious adverse effects were reported in cattle.
Marketing authorisations were withdrawn for veterinary medicines containing colistin in combination with other antibiotics that are administered orally throughout the EU. EMA advises that colistin only be used as a second-line treatment in animals and sales should be minimised across the EU.
Companies marketing medicines for small pets exempt from authorisation must submit their annual return to the Veterinary Medicines Directorate (VMD) by 30 November 2026.
