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
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 ...
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 ...
Mar 8, 2018 - Treatment of uterine fibroids. Haematology. New medicines authorised. ⢠Adynovi (rurioctocog alfa pegol). Treatment and prevention of bleeding in patients with haemophilia A. New information on authorised medicines. ⢠Feraccru (ferr
Treatment of cystine crystal deposits in the eye. New information on authorised medicines. Lucentis (ranibizumab) - change in indication. Treatment of visual ...
The new EudraVigilance system and the electronic reporting of individual case ... the ISO/ICH E2B(R3) format: hands-on training course - October 2017 ... granted a conditional marketing authorisation on the basis of less complete clinical data ...
PCWP and HCPWP joint meeting - Sept 2016 - meeting documents. ⢠Workshop on identifying opportunities for 'big data' in medicines development and ...
Used for the management of hypovolaemia (low blood volume) caused by acute (sudden) blood loss .... EMA's Business Continuity Plan for Brexit published.
RSS feeds you need one of the following: a modern web browser; a web-based news reader or a ... Withdrawal of applications for new medicines .... fifth annual regulatory conference on optimising the development of advanced therapies to.
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monitoring. 5. Guidelines. 5. Scientific .... Updated list of medicinal products under additional monitoring. Other information. Guidelines. Guidelines open for consultation ... CHMP -applications for new human medicines under evaluation: April 2016
desktop news reader. For a list of RSS readers please .... CHMP -applications for new human medicines under evaluation: April 2016. ⢠2016 work plan for the ...
Feb 16, 2017 - monitoring of several centrally authorised products ..... regulatory tools within the EU that are ... Following to this, a Rapid alert was circulated.
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For a list of RSS readers please refer to our RSS guide and follow the instructions .... granted a conditional marketing authorisation on the basis of less complete ...
HUMAN MEDICINES. HIGHLIGHTS. Issue 105. December 2017. This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use
Jan 29, 2018 - professionals. It provides a summary of key information relating to medicines for human use published ... Information is selected based on recommendations from consulted patients, consumers and healthcare professionals, and .... 30 Chu
Jan 31, 2017 - E-mail [email protected] Website www.ema.europa.eu ... 1) For new initial marketing authorisation (MA) applications via the centralised ...
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For a list of RSS readers please refer to our RSS guide and follow the instructions .... WEB-RADR workshop report: mobile technologies and social media as.
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Key information for patients, consumers and healthcare professionals. Published monthly by the European Medicines Agency. An agency of the European Union. HUMAN MEDICINES. HIGHLIGHTS. Issue 107. February 2018. This newsletter is addressed primarily t
Jan 31, 2017 - E-mail [email protected] Website www.ema.europa.eu ... 1) For new initial marketing authorisation (MA) applications via the centralised ...