Veterinary medicines highlights 2016

11

6

Positive opinions

1

New active substances

Negative opinion

1

Withdrawn application

New veterinary medicines Pigs

Chicken

Coliprotec F4/F18

Newborn calves

Atlantic salmon

Rabbits

Honey bees

Dogs

Cats

HALAGON

CLYNAV

Eravac

VarroMed

Cepedex Letifend Sedadex Sevohale

Cepedex Sedadex Stronghold plus

Evalon

Medicines that contain a new active substance are highlighted in blue

Innovations advancing animal health Protecting honey bees

Vaccines against emerging diseases

Honey Bees

Rabbits

VarroMed

Eravac

is an antiparasitic medicine that treats the Varroa mite infestation in honey-bee colonies, which is considered to be the most significant parasitic health concern affecting honey bees worldwide. The decline of these pollinators could lead to serious biological, agricultural, environmental and economic difficulties.

is a vaccine for the protection of rabbits against a new variant of rabbit haemorrhagic disease virus, called RHDV2, for which all current vaccines are ineffective.

Vaccines Chicken

Dogs

Evalon

Letifend

a vaccine that protects chicken against coccidiosis, a parasitic disease of the intestinal tract

a biotechnological vaccine based on a recombinant protein for dogs to protect them against leishmaniasis, a disease transmitted by sand flies

Atlantic salmon

Rabbits

CLYNAV

Eravac

a biotechnological vaccine based on a DNA plasmid that protects Atlantic salmon against pancreas disease caused by infection with salmonid alphavirus subtype 3

a vaccine that protects rabbits against a new variant of rabbit haemorrhagic disease virus, called RHDV2

Pigs Coliprotec F4/F18 a vaccine that protects against porcine post-weaning diarrhoea caused by Escherichia coli in pigs

This information reflects EMA’s recommendations whether or not an EU-wide marketing authorisation should be granted. The final decision is taken by the European Commission.

Medicines for minor use minor species (MUMS)* Rabbits

Atlantic salmon

Dogs

Honey bees

Eravac

CLYNAV

Letifend

VarroMed

Medicines against infectious diseases that could reduce the use of antimicrobials in animals Chicken

Pigs

Evalon

Coliprotec F18/F4

a vaccine that protects chicken against coccidiosis, a disease of the gut. Coccidial infections are widely treated with anticoccidial medicines which can have a potential risk of inducing resistance. The use of this vaccine to enhance resistance to infection might therefore have an indirect benefit in reducing the use of anticoccidial medicines***.

a vaccine that protects pigs against post-weaning diarrhoea caused by toxic Escherichia coli. This has the potential to change the current practice to give antibiotics to control infection in pig herds.

Antimicrobial resistance: EMA’s recommendation on colistin Colistin should only be used as a second-line treatment in animals and sales should be minimised across all European Union (EU) Member States. If use in animals is cut to 5mg colistin/ population correction unit**, an overall reduction of around 65% in the current sales of colistin for veterinary use at EU level could be achieved.

New uses for existing medicines

Important CVMP safety recommendations in 2016 •

Increase the withdrawal period of medicines containing gentamicin in cattle and pigs to enhance consumer safety; avoid administering gentamicin subcutaneously.



Take environment protection measures to make sure that altrenogest, a steroidal hormone for young female pigs and mares, has no adverse effects on the reproduction of aquatic organisms.



Refuse the marketing authorisations and withdraw currently authorised zinc oxide-containing medicines, used in medicated feeding stuff for piglets, as these products increase soil zinc concentrations to levels considered harmful for the environment.



Suspend Velactis after serious adverse events were reported in cattle, including recumbency (lying down or inability to stand up) and death.



Withdraw all marketing authorisations for veterinary medicines containing colistin in combination with other antibiotics that are administered orally throughout the EU.

The use of 4 known substances has been expanded in 2016: DRAXXIN to be also used against swine respiratory disease (SRD) Profender to be also used as a spot-on solution for cats Poulvac E. coli to be also used in turkeys Trifexis to be also used to treat and prevent flea infestations in dogs

*Minor use veterinary medicines are intended for use in major species such as cattle, sheep, pigs, chickens, Atlantic salmon, cats and dogs for the treatment of diseases that occur infrequently or occur in limited geographical areas. Minor species are all animals that are not one of the major species. **Clarified by replacing ‘by’ with ‘to’ on 26/01/2017. ***Amended on 08/03/2017 to better reflect the risk of inducing antimicrobial resistance.

European Medicines Agency 30 Churchill Place Canary Wharf London E14 5EU United Kingdom

website www.ema.europa.eu/contact +44 (0)20 3660 6000 Twitter @EMA_News

www.ema.europa.eu

Veterinary medicines highlights 2016 - European Medicines Agency

Jan 26, 2017 - is an antiparasitic medicine that treats the Varroa mite infestation in honey-bee colonies, which is considered to be the most significant parasitic ...

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