The maker, MSD Animal Health, says Numelvi is "the first and only second-generation Janus kinase (JAK) inhibitor indicated from six months of age (and 3kg) for the treatment of pruritus associated with allergic dermatitis, including atopic dermatitis, as well as the clinical manifestations of atopic dermatitis in dogs. .
It is given once daily and MSD says it is clinically effective after the first dose.
The company says itch relief begins within 2–4 hours and dosing is one tablet a day from day one.
MSD claims Numelvi is at least 10 times more selective for JAK1 compared with other JAK family members (JAK2, JAK3 and TYK2).
Numelvi can be used concurrently with vaccines (including rabies) and other common treatments such as ectoparasiticides, with no requirement for routine blood and urine monitoring.
Dermatology specialist Dr Debbie Gow said: “Second-generation JAK inhibitors are selective — specifically, in this case, more selective for JAK1 than other JAK enzymes.
“The high selectivity for JAK 1 contributes to the favourable safety profile of Numelvi.”
Dr Sue Paterson MA VetMB DVD DipECVD FRCVS added: “Treating canine allergic dermatitis means offering treatment which relieves itch and inflammation, whilst managing any unwanted side effects.
"We want to inhibit JAK 1 to reduce itch and inflammation, whilst having little to no effect on other JAK family members.”
MSD Animal Health will host a lunch-and-learn digital launch event with The Webinar Vet on Thursday 26 March, aiming to set a Guinness World Record for a veterinary educational launch event.
The review will consider whether the UK Veterinary Medicines Regulations 2013, which were were originally derived from EU legislation, protect animal and public health without adding unnecessary regulatory burden.
Anyone is able to share their views and experiences of the regulations, but the VMD is especially interested in hearing from vets, vet nurses, SQPs, marketing authorisation holders, farmers and pet owners.
Responses must be submitted before 23:59 on 26th September 2025
https://consult.defra.gov.uk/vmd-policy-development-and-delivery-office/mmd-act-2021-stakeholder-survey
The Health Products Regulatory Authority (HPRA) has also granted a marketing authorisation in exceptional circumstances (Article 25, 26 EU Reg 2019/6) for Bultavo 3 in Ireland.
The company says that so far, more than 40 million doses of Bultavo 3 have been distributed in Europe to help limit the spread of BTV-3.
Boehringer points to a recent field study published by the German reference laboratory Friedrich-Loeffler-Institut (FLI), which showed that vaccination of sheep and cattle with Bultavo 3 induces immunity against the virus1.
According to the study, animals vaccinated with Bultavo 3 consistently showed evidence of a protective antibody response to BTV-3, although animals vaccinated with other BTV-3 vaccines did not1.
Boehringer says it is now compiling the data needed to obtain a full marketing authorisation in accordance with Article 8 of EU Regulation 2019/6.
Reference
The updated indications reflect the recognition that Stelfonta may be used in any case where surgery may not be an option:
For the treatment of non-metastatic (WHO staging) mast cell tumours that are either non-resectable or those that are resectable but where surgery is not considered the best option, specifically: cutaneous mast cell tumours (located anywhere on the dog) and subcutaneous mast cell tumours located at or distal to the elbow or the hock.
Tumours must be less than or equal to 8 cm 3 in volume, and must be accessible to intratumoral injection.
Neil Mottram MRCVS, Technical Manager at Virbac said: “Stelfonta offers veterinary surgeons a medical option for the successful elimination of mast cell tumours.
"The extended labelled indication demonstrates the wide variety of cases that can benefit where medical treatment is preferred, such as; tumour factors (location and size) making surgical margins difficult, patient factors (concurrent disease and risk of anaesthesia), clinic factors and the simplification of this medical treatment and owner factors, where there is a preference to avoid surgery."
Stelfonta is administered by injection directly into the tumour mass and Virbac say that generally, dogs do not require sedation or local or general anaesthesia during treatment.
The active ingredient, Tigilanol tiglate, works largely through specific protein kinase c (PKC) activation, in which it locally stimulates the immune system, resulting in destruction of the tumour and the tumour’s blood supply, followed by rapid healing of the site with minimal scarring.
www.virbac.co.uk
The UK-Veterinary Antibiotic Resistance and Sales Surveillance (UK-VARSS) annual report shows that while sales of antibiotics increased slightly by 1.5 mg/kg to 31.0 mg/kg in comparison to the previous year, this was offset by a reduction in use of the more potent critical antibiotics.
UK veterinary antibiotic use in 2019 was the second lowest since the start of regular reporting, and the UK has one of the lowest levels in Europe.
Between 2018 and 2019 there was a 21% drop in of use of Highest Priority Critically Important Antibiotics (HP-CIAs) in food-producing animals, which account for 0.5% of total antibiotic sales. The UK has also seen an overall reduction in the level of resistance in E. coli from healthy pigs at slaughter since 2015 and resistance to HP-CIAs in E. coli is at very low levels.
Peter Borriello, Chief Executive Veterinary Medicines Directorate said: "In the last five years we have worked closely with the farming industry and veterinary profession to achieve huge reductions in use of antibiotics in animals.
"This demonstrates how farmers and vets have been working together to use antibiotics responsibly while safeguarding the health and welfare of our livestock.
"The UK Government will continue to work with industry to focus on infection control, reducing the need to use antibiotics to treat disease and maintain the UK’s world leading standards in animal welfare."
Chief Veterinary Officer Christine Middlemiss said: "I am delighted that the UK continues to lead the way as one of the lowest users of antibiotics in livestock across Europe.
"These findings are testament to the hard work of the UK’s farmers and vets to use antibiotics responsibly in order to tackle antibiotic resistance and protect our most critically important antibiotics in human health, while also reducing the burden of disease in animals."
Till then, veterinary surgeons are advised to make due diligent attempts to source a UK-authorised product before considering importing an alternative medicine.
Procaine hydrochloride is used in farm animal medicine in particular, to provide local and regional anaesthesia for a range of procedures including calving, lambing, caesarean operations, castration and dehorning of cattle, with demand particularly high in the spring.
Simon Doherty, BVA President, said: "We’re pleased that VMD has issued some clarification to answer our concerns over procaine hydrochloride shortages. BVA had heard from some veterinary practices that they were only able to get hold of a fraction of what they needed, which would have resulted in a very acute impact on farm animal welfare. Although we had moved to get assurances sooner, we appreciate that there are formal routes for reporting and that the announcement of any shortage must be handled sensitively to avoid exacerbating the problem.
"VMD’s clarification is especially timely as this is a period of peak seasonal demand for these products. We will keep our members closely informed of any further developments."
"The majority of veterinary medicines used in the UK (and ingredients and components to make them) are either produced in or enter via the EU. The government is working with animal health companies who have been carrying out extensive contingency planning for all EU Exit scenarios, including no deal. These plans cover all aspects of their supply chains, from regulatory compliance and stocking levels to logistics and customs. They also include, as appropriate, increasing stocks of products in the UK, changing supply routes, transferring marketing authorisations and other regulatory processes.
"To reduce any risk to medicines availability in the UK, detailed planning is ongoing to ensure that supply chain measures are appropriate to address the sector’s complex needs and priorities.
"Much work has been done by companies with the objective of ensuring fair and appropriate distribution of this inventory to avoid disruption.
"Supply is expected to cope with a normal ordering pattern with adequate forward planning and communication with suppliers.
"With this planning in place, we are confident that we have made every effort to ensure continuity of supply of veterinary medicines in the UK."
Well that makes a nice change from the incessantly and determinedly gloomy picture painted elsewhere.
Having investigated alternative sources of isoflurane, and alternative products, the associations proposed ways that the VMD might mitigate the risks to animal welfare including consenting to the use of unlicensed (“special”) isoflurane formulations.
The VMD responded rapidly and positively. It is understood that one specials manufacturer is now intending to produce isoflurane to fill or partially fill the gap in supply. This should be available in three to four weeks.
David Rendle, a member of BEVA’s Health and Medicines Committee commented: "BEVA has a close relationship with the veterinary pharmaceutical industry and will always work swiftly and collaboratively to help develop practical solutions to supply problems for our members."
BSAVA President Philip Lhermette praised the VMD for such prompt action. He said: "The VMD listened to our concerns and acted immediately. By doing so they have addressed and helped to prevent any potential welfare risks associated with a lack of isoflurane."
Carl Bradbrook, AVA Junior Vice President, reminded clinicians to "seek advice when considering the use of unfamiliar anaesthetic protocols."
The associations say that the situation doesn’t give vets free rein to ignore the medicines legislation; the cascade must still be followed, and client informed consent obtained if an unregulated anaesthetic is used.
Extemporaneous products are the last tier of the cascade. Vets are expected to use either an authorised human medicine or an EU authorised veterinary medicine before an extemporaneous preparation. If, after diligent attempts to source a product higher up the cascade, the vet has not been successful they could consider using an extemporaneous preparation for the immediate need. However, should an authorised product or a human product become available vets are obliged to use it over an extemporaneous preparation.
BEVA, the BSAVA and the AVA have each produced general advice on the use of specials or anaesthesia options at https://www.bsava.com/News/ArticleID/2535/Isoflurane-supply, https://www.beva.org.uk/Resources-For-Vets-Practices/Medicines-Guidance/Veterinary-specials and https://ava.eu.com/
Veterinary medicines are defined in the Veterinary Medicines Regulations as:
"any substance or combination of substances that may be used in, or administered to, animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis."
On this basis, the VMD says CBD products for use in animals require a marketing authorisation before they can be sold or supplied in the UK.
There are currently no CBD based products that have been granted a UK veterinary marketing authorisation which means that under the cascade, veterinary surgeons must prescribe a legally obtained human CBD product.
Photo: Shutterstock / Lifestyle discover
All bar one of the suspended drugs contain the NSAID flunixin. The other affected drug is the antibiotic, Tribrissen:
Allevinix 50 mg/ml Solution for Injection for Cattle, Pigs and Horses (Ceva Animal Health)
Cronyxin Injection, 5% w/v Solution for Injection, for cattle and horses (Cross Vetpharm Group Ltd)
Finadyne 50 mg/ml Solution for Injection for cattle, pigs and horses (Intervet UK Ltd)
Flunixin 50 mg/ml Solution for Injection for Cattle, Horses and Pigs (Norbrook Laboratories Limited)
Meflosyl 5% Solution for Injection for horses and cattle (Zoetis UK Limited)
Norixin 5% Solution for Injection for cattle and horses (Norbrook Laboratories Limited)
Pyroflam 50 mg/ml Solution for Injection for Cattle, Horses and Pigs (Norbrook Laboratories Limited)
Tribrissen 48% Suspension for Injection for horses, pigs and cattle (Intervet UK Ltd)
The British Equine Veterinary Association says that the decision to suspend the drugs was taken without consultation with the veterinary profession, and is urging the VMD to overturn the suspension in horses not destined for the human food chain, to reduce the potential impact on equine welfare.
Jonathan Pycock, BEVA president said: "BEVA is fully supportive of all attempts to promote food safety, however flunixin is widely viewed as the gold-standard pain killer in horses and is commonly used in horses undergoing both elective and emergency surgery, for the crippling pain associated with laminitis and for severe forms of colic.
"BEVA is calling on the VMD to immediately enable limited batch release of flunixin for use in horses not destined for the human food chain in the interests of animal welfare. The equine veterinary profession has always been open to consultation with the VMD on a range of important matters relating to responsible medicine use, antibiotic resistance, horse identification, passports and the horse meat issue. BEVA is perplexed as to why the VMD failed to consult with the equine veterinary industry on the animal welfare impact of withdrawing such an important drug.”
Batches 060K80412C1A-UK1-2 and 060K80412A1C-UK1-2 (expiry 12/06/2019) have been recalled due to incorrect storage requirements during shipment.
For further information, contact Jerome Martineau at: jerome.martineau@filavie.com, or telephone: +33 2 41 754616
At present veterinary surgeons must destroy Schedule 2 controlled drugs in the presence of and directed by either an inspector appointed under the Veterinary Medicines Regulations, another veterinary surgeon independent of the practice where the destruction takes place, or a person legally authorised to witness the destruction of controlled drugs such as a Police CD Liaison Officer (CDLO).
This is something which may be helped by the launch of VetSurgeon Connect, a new map-based service on VetSurgeon.org designed to help members of the profession collaborate in a wide range of areas, including controlled drug disposal. VetSurgeon Connect is expected to launch next week.
Meanwhile, the VMD notes that there is a shortage of CDLOs and there are areas of the country where there are no local inspectors, or independent vets who can perform the task. Hence the survey to reveal the size of the problem.
The survey, which should take no more than 15 minutes, is open to all UK registered veterinary surgeons and closes on the 6th June. Here's the link: https://www.surveymonkey.co.uk/r/SHKTBYH
Any questions about the survey can be directed to: the VMD legislation team on 01932 338316 or controlleddrugssurvey@vmd.defra.gsi.gov.uk
5638 events were reported spontaneously, mainly by the marketing authorisation holder (61%), with the remainder largely reported by veterinary surgeons.
Of these, 5512 were reports of adverse reactions in animals: 829 concerning suspected lack of efficacy, 4638 concerning safety. The majority of reports concerned dogs (2927), cats (1426) and cattle (386).
In dogs, medicines for the control of epilepsy were most often suspected of not having performed as expected (80 reports) whilst vaccines were most commonly reported as having failed to work (71). However, the VMD points out that in many cases, vaccination failure was attributable to other causes (such as incomplete vaccination schedule).
In cats, flea spot-on products were most likely to be reported as not having worked (21). However, there are many reasons why owners may continue to see live fleas on their animal which are unrelated to product efficacy (such as reinfestation from the environment).
Notably, the majority of efficacy reports in horses (12/19) related to euthanasia products, which the report says should serve as a reminder that alternative means of euthanasia should always be available in case the chosen method does not proceed as planned.
Of the safety reports, 59.6% involved dogs, 31% cats, 4.9% horses and 3.9% rabbits. The majority concerned vaccines (1360 reports, most commonly general signs or symptoms, such as lethargy or pyrexia), parasiticides (472 reports, most commonly lethargy, emesis, inflammation/pruritus, depending on method of administration) and inflammation control (412 cases, most commonly emesis, renal insufficiency and diarrhoea, depending on the drug type).
There were 124 reports of adverse events in humans. Of those involving veterinary professionals (about a quarter):
The VMD says that reports of needle stick injuries involving vaccines with a mineral oil adjuvant are of particular concern, because they often fail to show that the injured party has received prompt and correct treatment, either because they are themselves unaware of the necessity for swift intervention, or because they do not take the product package information leaflet with them when seeking medical treatment.
Similarly, the VMD says that incidents involving injectable tilmicosin seem to be often dismissed as just a scratch, and that if you use these products, you should make sure you are fully aware of the warnings contained in the product leaflets.
To read the full report, visit: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/608968/PhV_Annual_Review_2015_v7.pdf
The recategorisation means that pharmacists and Suitably Qualified Persons (SQPs) will be able to prescribe Zolvix.
The VMD says that making the anthelmintic more widely available will increase its usage as part of strategic worm control programmes on farms, which could in turn result in long term health benefits for sheep, for example by reducing the development and spread of anthelmintic resistance, thereby prolonging the effective use of anthelmintics.
The VMD adds that SQPs will now have additional training to ensure they are sufficiently familiar with Zolvix and how to prescribe it effectively and responsibly so that it is used appropriately. A new compulsory training module will be implemented by The Animal Medicines Training Regulatory Authority (AMTRA) to augment the skills of all AMTRA-registered SQPs permitted to prescribe farm animal products. New SQPs will be required to undertake a revised and extended module before gaining their farm animal registration with AMTRA.
Pharmacists and SQPs will be able to prescribe Zolvix from 1st July 2017.
UPDATE 16th March:
BVA President Gudrun Ravetz has issued a statement expressing concern over the recategorisation of Zolvix:
"We know that resistance to anthelmintics is increasing in grazing animals and needs to be addressed if the livestock industry is to avoid a potentially disastrous situation of being unable to tackle parasites. The reclassification of Zolvix from POM-V to POM-VPS is in direct opposition to the trend in Europe, where we are seeing increased control over dispensing of anthelmintics in species where resistance is a serious threat to animal welfare and profitable production; we're extremely concerned that we might start seeing resistance develop in group 4 as a result.
"BVA believes that prescribing of anthelmintics requires a level of control best provided by a veterinary surgeon who has the animals under his/her care, and is based on a sound clinical diagnosis, in order to protect animal welfare and safeguard the efficacy of these products for the future."
Further information on BVA's policy on anthelmintics can be found on BVA’s website: www.bva.co.uk/news-campaigns-and-policy/policy/medicines/anthelmintics.
The affected batches are: IsoFlo 250 ml 58006XN, 60003XN, 59005XN, 60006XN, 61001XN, 60016XN, 60017XN, 61018XN, 61015XN, 61016XN, 61017XN, 6062216, 6062225, 6062226, 6062217, 6063738 and Isothesia 250ml 6062335, 6063318.
Manufacturer Zoetis says there were a small number of reports of veterinary surgeons having difficulty in re-sealing the bottles after initial opening as the thread on the screw cap had not been fully formed. This defect does not impact the safety and efficacy of the product for animal use but the concern was related to potential evaporation from opened bottles which did not re-seal fully when closed.
Veterinary surgeons are asked to return any unopened bottles to the wholesaler and dispose of any opened bottles in the usual way. They will be fully reimbursed for the stock.
Zoetis says it has already addressed this packaging issue at the manufacturing site so that new batches of the product are unaffected.
Practices requiring further information on the matter should call Zoetis Technical Services on 0845 300 8034.
Velactis (cabergoline) is a POM marketed by Ceva Animal Health, used in the herd management programme of dairy cows as an aid in abrupt drying-off, by reducing milk production.
The product was authorised through the European Medicines Agency (EMA) in December 2015 and was first sold in the UK in April 2016.
The VMD says it has been made aware of reports of serious adverse events, predominantly occurring in Denmark, involving recumbency (lying down and unable to rise) and some deaths. Most adverse events occurred within 8 to 24 hours following product administration. Anecdotal evidence suggests that hypocalcaemia treatments may be successful in reversing clinical signs.
Ceva has decided to stop further distribution of the product in Europe voluntarily, pending the outcome of further investigations to assess a possible causal link between the product and the adverse events reported.
The VMD, EMA, other agencies throughout Europe and the MAH are working closely to monitor the situation.
The VMD highlights that due to the nature and use of the product there is no risk to human health or consumer safety.
Vets and dairy farmers are strongly encouraged to report any adverse events associated with use of Velactis to the VMD using its online reporting form or directly to Ceva for further investigation by the MAH as necessary.
The Veterinary Medicines Directorate (VMD) has granted MSD Animal Health a provisional UK marketing authorisation for Bovilis SBV, the first vaccine specifically targeting the Schmallenberg virus (SBV) in cattle and sheep.
SBV, which emerged in late 2011, is transmitted via insect vectors, mainly midges and causes transient clinical symptoms in adult cattle and sheep, such as fever, diarrhoea and reduced milk yield, as well as congenital malformation in newborn calves and lambs. As of March 31st 2013, 1753 cases of SBV had been confirmed throughout the UK. SBV has now been detected in every county in England and Wales.
Andras Bolcskei, Country Manager, MSD Animal Health UK said: "On behalf of Merck MSD, we would like to thank the VMD for its partnership and support to fast track the availability of Bovilis SBV to the market. There was a tremendous urgency for a SBV vaccine in the UK especially given the marked increase in confirmed cases over the past year and the increasing importance to help control this devastating disease."
MSD says that studies it conducted in support of the provisional marketing authorisation showed that all animals responded with formation of virus neutralizing antibodies. During the studies, reduced viraemia against SBV was observed in sheep vaccinated once and prevention of viraemia was observed in cattle vaccinated twice, whereas all animals in the control groups developed infection and became viraemic. In studies to date, Bovilis SBV has been shown to be efficacious in cattle and sheep.
The vaccine is based on wild-type SBV that has been inactivated and contains an adjuvant that stimulates the immune response.
The vaccine will be available in 20ml and 100ml vials. Bovilis SBV is indicated for the active immunisation of cattle to prevent viraemia against SBV and for the active immunisation of sheep to reduce viraemia against SBV.
MSD says it is working diligently to expedite stocks to the UK, and expects Bovilis SBV to arrive in the UK in the coming weeks.
Following ongoing lobbying by the British Veterinary Association and others, the Veterinary Medicines Directorate has dropped controversial plans for a new veterinary medicines category - POM EA (prescription-only medicine extended administration).
The proposed category has been discussed at the Veterinary Products Committee (VPC) since 2009. The original purpose was to provide a new category under which a veterinary surgeon would make a clinical assessment and, if appropriate, issue a Veterinary Permission of Extended Administration (VPEA) allowing the animal holder to obtain the prescribed POM EA medicine (from a veterinarian, pharmacist or SQP) for up to 36 months from the date of authorisation.
The BVA, along with its specialist divisions, says it opposed POM EA from the outset and failed to see that there was any justification for a new category. Veterinary surgeons are already able to write prescriptions for extended use and, as most health plans are reviewed annually, anything beyond a yearly assessment would be unacceptable on health and welfare grounds. An additional category would have also taken the UK even further out of step with the rest of the EU.
The BVA submitted written comments and attended a stakeholder meeting with the VMD to discuss concerns. Despite the VMD suggesting revisions to the original proposal the BVA and other stakeholders maintained that the new category was unnecessary.
Following these consultations, the VPC decided, at a meeting in March, not to progress the proposal any further.
Harvey Locke, President of the BVA, said: "We are extremely pleased that the Veterinary Products Committee has listened to our concerns and decided to drop its plans for POM EA.
"The BVA felt strongly that the proposed new category was unnecessary at best and potentially harmful to animal health and welfare at worst.
"In all fields of practice veterinary surgeons would not feel comfortable prescribing for such long periods without regular contact with the animals they care for."
The Veterinary Medicines Directorate has published the results of the distribution category review, which has recommended the re-classification of 50 products from POM-V or POM-VPS to a less restrictive distribution category.
Not all the products recommended for reclassification will be reclassified, as in some cases, the Marketing Authorisation Holder (MAH) has declined.
MAH will change the distribution category from POM-V to NFA-VPS:Advantage Spot-on Solution for dogs, cats, small cats, small dogs and pet rabbitsDuowinScalibor Protectorband for dogsTop Drop Spot-on Solution for dogs
MAH will change the distribution category from POM-V to POM-VPS:Alpha Ject 2-2Aquavac FNM Plus VaccineAquavac FurovacFurogen 2LactovacLeptavoid HNobilis CAV P4ParacoxParacox 5 oral suspensionRotavec CoronaSpirovacSuvaxyn Ery
MAH will change the distribution category from POM-VPS to AVM-GSL:Coprite
MAH will change the distribution category from POM-V to AVM-GSL:Rearguard
MAH has decided not to change the distribution category from POM-V to NFA-VPSAdvantix Spot-on Solution for dogsFleegard for dogs / cats Frontline Combo spot on for cat and dogFrontline SprayTop Drop
Those Marketing Authorisation Holders that have indicated they are content with the recommendations are required to submit a variation to change the distribution category for the products involved by 30th June 2010, and the variations will come into force at the next label reprint.
For the full report, and a complete list of the affected products, please visit the VMD website here.
Urging vets to 'get off their backsides and respond to a VMD consultation' on the introduction of a new POM-EA category (Vet Times, 19th October) is premature.
Contrary to the report, the VMD has not yet launched a formal consultation.
Jo Cawthorne from the VMD said: "In fact, we've only launched an informal consultation on a concept note amongst a small group of key stakeholders from the RCVS, BVA, RPSGB, AMTRA, AHDA and NOAH, in order to decide whether this is a viable idea and merits a formal consultation."
She added: "There is no need for vets to respond to a consultation which doesn't yet exist. If there is a formal consultation, it will be announced formally on our website and everyone will be given the opportunity to respond."