The Committee for Medicinal Products for Veterinary Use (CVMP) held a meeting on 8 and 9 April.
The Committee adopted positive opinions for marketing authorisations for three veterinary medicines :
- Emevet (maropitant), for the prevention of nausea induced by chemotherapy and motion sickness in dogs.
- Nobilis Multriva IBm+ND, for the active immunisation of chickens against infectious bronchitis and Newcastle disease virus.
- Nobilis Multriva Gm+REOm for the active immunisation of chickens for passive immunisation of the progeny of the vaccinated chickens against infectious bursal disease and avian reovirus.
The Committee also approved quality-related variations for Clevor and ReproCyc ParvoFLEX, and other opinions for variations requiring assessment for Newflend ND H9, Vectormune ND and Zycortal.
It was informed that TriviumVet has withdrawn the application for initial marketing authorisation of Sirolimus TriviumVet.
Three scientific advice reports were adopted, and a fourth was clarified, covering biological, immunological and pharmaceutical products for dogs, honeybees, and horses.
A draft paper on the environmental risk assessment of antimicrobial resistance was adopted and will be open for public consultation for six months.
Finally, dibutyl sebacate was added to the list of substances exempt from Regulation (EC) No 470/2009, that sets safe residue limits of veterinary medicines in food of animal origin, under the category of excipients, and adopted the revised list.