Monthly medicines update
Summary of new marketing authorisations and changes to existing authorisations that relate to the safe use of the product
A rolling 6 month summary with the most recent one first.
Our Product Information Database (PID) is your primary resource for the most current information about all veterinary medicines authorised in Great Britain and Northern Ireland. As product details change we update the Summary of Product Characteristics (SPC) and label text there. Please note there may be a delay before formal documentation is available for some Northern Ireland products.
It may take up to 12 months for changes to appear on marketed packaging.
Products are authorised separately in Great Britain and Northern Ireland although authorisations may be aligned if they are the same product held by the same authorisation holder. This may mean that products are authorised or changed on different timescales in each territory.
Also find here a list of specific Pregnancy Warnings which we update quarterly.
April 2025
New Authorisations
-
Bluevac-3 Suspension for Injection for Sheep and Cattle
Active substance: Bluetongue Virus
Territory / Distribution category: GB &NI POM-V
Authorisation holder: CZ Veterinaria S.A.
NI SPC available from EU Union
-
Bultavo 3 Suspension for Injection for Sheep and Cattle
Active substance: Bluetongue virus
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Boehringer Ingelheim Animal Health UK Limited
-
Diclacare 2.5 mg/ml Oral Suspension for Lambs and Calves
Active substance: Diclazuril
Territory / Distribution category: NI POM-V
Authorisation holder: Laboratorios Karizoo S.A
-
Triclacert Duo 50 mg/ml & 1 mg/ml Oral Suspension for Sheep
Active substance: Triclabendazole, Ivermectin
Territory / Distribution category: GB POM-V
Authorisation holder: EU Pharmaceuticals Ltd
-
Censutrim 200 mg/ml + 40 mg/ml Solution for Injection for Cattle, Pigs, Horses, Dogs and Cats
Active substance: Sulfadiazine, Trimethoprim
Territory / Distribution category: GB POM-V
Authorisation holder: DUGV (UK) Limited
-
Benamix 6.25 mg/g Premix for Medicated Feeding Stuff for Cats
Active substance: Benazepril
Territory / Distribution category: GB & NI POM-V
Authorisation holder: VIRBAC
-
Bravecto TriUNO Chewable Tablets for Dogs [Range]
Active substance: Fluralaner, Moxidectin, Pyrantel
Territory / Distribution category: GB & NI POM-V
Authorisation holder: MSD Animal Health UK Limited
-
Elmaro 10 mg/ml Solution for Injection for Dogs and Cats
Active substance: Maropitant
Territory / Distribution category: NI POM-V
Authorisation holder: Elanco GmbH
SPC available from EU Union Product Database
-
Ezi-Wormer Film-coated Tablets for Cats 16/40 mg (Milbemycin/Praziquantel)
Active substance: Milbemycin Oxime (A3 and A4), Praziquantel
Territory / Distribution category: GB POM-V
Authorisation holder: C&H Generics Ltd
-
Prevestrus Vet Film-Coated Tablets for Dogs [Range]
Active substance: Finrozole
Territory / Distribution category: NI POM-V
Authorisation holder: Vetcare Oy
Link to SPC 25mg
Link to SPC 50mg
Link to SPC 100mg
-
Vetmedin 1.5 mg/ml Oral Solution for Dogs
Active substance: Pimobendan
Territory / Distribution category: NI POM-V
Authorisation holder: Boehringer Ingelheim Animal Health UK Limited
-
Wormax Film-coated Tablets for Cats 16/40 mg
Active substance: Milbemycin Oxime (A3 and A4), Praziquantel
Territory / Distribution category: GB POM-V
Authorisation holder: C&H Generics Ltd
-
Wormit Film-coated Tablets for Cats 16/40 mg
Active substance: Milbemycin Oxime (A3 and A4), Praziquantel
Territory / Distribution category: GB POM-V
Authorisation holder: C&H Generics Ltd
Variations - food producing species
-
Medesedan 10 mg/ml Solution for Injection for Horses and Cattle
Active substance: Detomidine Hydrochloride
Territory / Distribution category: GB & NI POM-V
Authorisation holder: CP Pharma Handelsgesellschaft mbH
Summary of change:
Multiple extensive updates have been made in relation to the SPC sections; 3.3 Contraindications, 3.5 Special precautions for use; 3.6 Adverse events, 3.7 Fertility, use during pregnancy and lactation, 3.9 Administration in combination with other sedatives and anaesthetics and 3.10 Overdose.
-
Detogesic 10 mg/ml Solution for Injection for Horses
Active substance: Detomidine Hydrochloride
Territory / Distribution category: NI POM-V
Authorisation holder: Vetcare Limited
Summary of change:
Multiple extensive updates have been made in relation to the SPC sections; 3.2 Indications, 3.3 Contraindications, 3.5 Special precautions for use, 3.6 Adverse events, 3.7 Fertility, use during pregnancy and lactation, 3.8 Interactions with other medicinal products, 3.9 Administration routes and dosage, 3.10 Overdose and 4.2 and 4.3 Pharmacology.
-
Vigophos 100 mg / ml + 0.05 mg / ml Solution for Injection for Cattle, Horses and Dogs
Active substance: Butafosfan, Cyanocobalamin
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Livisto Int'l, S.L.
Change category: Target species
Summary of change:
The veterinary medicinal product is now authorised for use in horses for supportive treatment and prevention of hypophosphataemia and/or cyanocobalamin (vitamin B12) deficiency, and as an adjunctive therapy in horses suffering from muscular exhaustion. Extensive associated changes have been made to multiple sections of the SPC due to the addition of this new target species.
See under Companion animals listing for changes relevant for use in dogs.
-
Zermex 100 mg/ml LA Solution for Injection for Cattle
Active substance: Moxidectin
Territory / Distribution category: GB & NI POM-VPS
Authorisation holder: Zoetis UK Limited
Change category: Contraindications, Special warnings; Adverse reactions; Target species use.
Summary of change:
Sections 4.4 and 4.5 have been updated to provide further warnings and precautions to advise on safe and effective use.
Section 4.6 has been updated to indicate that on very rare occasions, hypersensitivity reactions and/or neurological disorders (such as collapse, convulsion, paralysis, and blindness) may occur. Severe reactions may be fatal.
Section 4.9 has been updated to provide further general information regarding dosing.
-
Zermex 20 mg/ml LA Solution for Injection for Sheep
Active substance: Moxidectin
Territory / Distribution category: GB & NI POM-VPS
Authorisation holder: Zoetis UK Limited
Change category: Contraindications, Special warnings; Adverse reactions;
Summary of change:
Section 4.4 has been updated to provide further warnings relating to effective use.
Section 4.6 has been updated to indicate that on very rare occasions, neurological disorders such as collapse, convulsion, and paralysis may occur. Severe reactions may be fatal.
Variations - Companion animal species
-
Osurnia Ear Gel for Dogs
Active substance: Terbinafine, Florfenicol, Betamethasone acetate
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Dechra Limited (GB) Dechra Regulatory B.V. (NI)
Change Category: Contraindications, Special warnings; Adverse reactions
Summary of change:
Information relating to the occurrence of eye disorders, despite no direct ocular contact, has been removed from section 4.5. Instead, section 4.6 has been updated to indicate that in very rare cases, eye disorders such as neurogenic keratoconjunctivitis sicca, keratoconjunctivitis sicca, corneal ulcer, blepharospasm, eye redness and ocular discharge have been reported in treated dogs. Additionally, ataxia, internal ear disorders (mainly head tilt), facial paralysis and nystagmus have been reported in very rare cases.
NI SPC Available from EU Union Product Database
-
StromEase 25 mg/ml Eye Drops, Solution for Dogs and Cats
Active substance: Acetylcysteine
Territory / Distribution category: GB & NI POM-V
Authorisation holder: DOMES PHARMA
Change Category: Adverse events
Summary of change:
Section 4.6 has been amended to clarify that irritation or inflammation of the eye and/or its adnexa have been reported in very rare cases, especially blinking of the eyelids or even closure of the eye, eye redness or conjunctival oedema, particularly in dogs.
-
Vigophos 100 mg / ml + 0.05 mg / ml Solution for Injection for Cattle, Horses and Dogs
Active substance: Acetylcysteine
Territory / Distribution category: GB & NI POM-V
Authorisation holder: DOMES PHARMA
Change Category: Target species
Summary of change:
The veterinary medicinal product is now authorised for use in dogs for supportive treatment and prevention of hypophosphataemia and/or cyanocobalamin (vitamin B12) deficiency. Extensive associated changes have been made to multiple sections of the SPC due to the addition of this new target species.
March 2025
New Authorisations
-
Censutrim 200 mg/ml + 40 mg/ml Solution for Injection for Cattle, Pigs, Horses, Dogs and Cats
Active substance: Sulfadiazine, Trimethoprim
Territory / Distribution category: NI, POM-V
Authorisation holder: DUGV (UK) Limited
-
Cevac Salmune ETI K Suspension for Injection for Chickens
Active substance: Salmonella enterica subsp. enterica
Territory / Distribution category: GB POM-V
Authorisation holder: Cevac Salmune ETI K
-
Intramar Lacto 200mg + 50mg + 10mg Intramammary Suspension for Cattle
Active substance: Amoxicillin, Clavulanic acid, Prednisolone
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Bioveta, a.s.
-
Mastic Seal 2.6 g Intramammary Suspension for Cattle
Active substance: Bismuth subnitrate
Territory / Distribution category: GB POM-V
Authorisation holder: Bioveta, a.s.
-
Taurador 10 mg/ml Solution for Injection for Cattle & Sheep
Active substance: Doramectin
Territory / Distribution category: GB & NI POM-VPS
Authorisation holder: Norbrook Laboratories Limited
-
ArthriCox 57 mg Chewable Tablets for Dogs; ArthriCox 227 mg Chewable Tablets for Dogs
Active substance: Firocoxib
Territory / Distribution category: GB POM-V
Authorisation holder: Norbrook Laboratories Limited
-
ButorVet 10 mg/ml Solution for Injection for Horses, Dogs and Cats
Active substance: Butorphanol
Territory / Distribution category: GB & NI POM-V
Authorisation holder: C&H Generics Ltd
-
OsteoCox 57 mg Chewable Tablets for Dogs; OsteoCox 227 mg Chewable Tablets for Dogs
Active substance: Firocoxib
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd
-
Vetmedin 1.5 mg/ml Oral Solution for Dogs
Active substance: Pimobendan
Territory / Distribution category: GB POM-V
Authorisation holder: Boehringer Ingelheim Animal Health UK Limited
Variations - food producing species
-
Alamycin LA 200 mg/ml Solution for Injection for Cattle, Sheep and Pigs; Alamycin LA 300 Solution for Injection 300 mg/ml [Cattle, Pigs, Sheep]
Active substance: Oxytetracycline
Territory / Distribution category: UK POM-V
Authorisation holder: Norbrook Laboratories Limited
Change Category: Adverse reactions
Summary of change:
Section 4.6: The following adverse event associated with the frequency very rare has been change to: “hypersensitivity, allergic or anaphylactic type reactions may occur that in extreme cases may be fatal.”
-
Fly & Lice Spot On Insecticide 1% w/v Cutaneous Solution [Cattle, Sheep]
Active substance: Deltamethrin
Territory / Distribution category: UK POM-VPS
Authorisation holder: Zoetis UK Limited
Change Category: Adverse reactions
Summary of change:
Section 3.6: Application site reactions, including squamosis and pruritus have been very rarely seen in cattle during the 48 hours after treatment.
The frequency of adverse reactions is defined using the following convention:
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
-
MS-H Vaccine eyedrops suspension [Chickens]
Active substance: Mycoplasma synoviae
Territory / Distribution category: GB POM-V
Authorisation holder: Pharmsure International Ltd
Change Category: Name change, Target species use; Contraindications, Special warnings
Summary of change:
Section 1 and 4.9: Change of the pharmaceutical form and route of administration from eye drops suspension and ocular use to oculonasal suspension and oculonasal use respectively.
Section 4.5: All birds in a flock/common housed group must be vaccinated at the same time.
Variations - Companion animal species
-
Simparica Trio Chewable Tablets for Dogs [Range]
Active substance: Moxidectin, Pyrantel, Sarolaner
Territory / Distribution category: NI POM-V
Authorisation holder: Zoetis Belgium
Change Category: Indictions for use
Summary of change:
Section 3.2: For reduction of the risk of infection with Dipylidium caninum via transmission by Ctenocephalides felis for one month after treatment. The effect is indirect due to product’s activity against the vector.
Section 4.2: Sarolaner reduces the risk of infection with Dipylidium caninum via transmission by Ctenocephalides felis by killing the fleas before disease transmission occurs.
SPCs available from the EU Union Product Database
February 2025
New Authorisations
-
Beaphar Flea 11.4 mg Tablets for Cats; Beaphar Flea 11.4 mg Tablets for Small Dogs; Beaphar Flea 57 mg Tablets for Medium & Large Dogs
Active substance: Nitenpyram
Territory / Distribution category: GB AVM-GSL
Authorisation holder: Elanco Europe Ltd
Link to SPC Medium and Large Dogs
-
Lozenord 5 mg/ml Solution for Injection for Dogs and Cats
Active substance: Meloxicam
Territory / Distribution category: NI POM-V
Authorisation holder: Accord Healthcare B.V
Variations - food producing species
-
Avishield ND, Lyophilisate for Oculonasal Suspension/Use in Drinking Water, for Chickens and Turkeys
Active substance: Newcastle disease virus
Territory / Distribution category: NI POM-V
Authorisation holder: Genera Inc.
Change Category: Contraindications, Special warnings
Summary of change:
Section 4.7: Deletion of the safety warning not to use the vaccine during lay and from 4 weeks before the onset of lay in chickens but not in turkeys as follows;
Laying birds
Chickens: Vaccination during lay is safe when it is performed in laying chickens which are already immunised against Newcastle disease virus by vaccination.
Turkeys:
Do not use in birds in lay and within 4 weeks before the start of the laying period.
-
Bovilis Nasalgen-C Nasal Spray, Lyophilisate and Solvent for Suspension for Cattle
Active substance: Bovine coronavirus
Territory / Distribution category: GB POM-V
Authorisation holder: MSD Animal Health UK Limited
Change Category: Contraindications, Special warnings
Summary of change:
Section 3.7: Deletion of the safety warning not to use the vaccine during pregnancy as follows; Pregnancy and lactation: Can be used during pregnancy.
-
MS-H Vaccine eyedrops suspension [Chickens]
Active substance: Mycoplasma synoviae
Territory / Distribution category: NI POM-V
Authorisation holder: Pharmsure International Ltd
Change Category: Contraindications, Special warnings
Summary of change:
Section 3.5: Revision of special precautions for safe use in the target species by strengthening the warnings and the description of flock testing.
Link to SPC to follow
Variations - Companion animal species
-
Drontal Plus Flavour Tablets for Dogs
Active substance: Febantel; Praziquantel; Pyrantel Embonate
Territory / Distribution category: UK NFA-VPS
Authorisation holder: Vetoquinol UK Limited
Change Category: Name Change
Summary of change:
Change in name to Johnson’s Wormer Plus 150/144/50mg Tablets for Dogs & Puppies.
-
Stronghold Plus 15 mg/2.5 mg Spot-on Solution for Cats ≤2.5 kg; Stronghold Plus 30 mg/5 mg Spot-on Solution for Cats >2.5–5 kg; Stronghold Plus 60 mg/10 mg Spot-on Solution for Cats >5 – 10 kg
Active substance: Sarolaner Selamectin
Territory / Distribution category: GB POM-V
Authorisation holder: Zoetis UK Limited
Change Category: Target species use; Contraindications, Special warnings
Summary of change:
Section 4.2: Addition of 'Treatment of notoedric mange (Notoedres cati)' to the indications for use.
Section 4.4: Added 'The efficacy of the veterinary medicinal product has not been established in cats with severe clinical signs of notoedric mange'.
-
WORMclear Praziquantel 20 mg Spot-on Solution for Cats
Active substance: Praziquantel
Territory / Distribution category: UK AVM-GSL
Authorisation holder: Vetoquinol UK Limited
Change Category: Contraindications, Special warnings; Adverse reactions
Summary of change:
Section 4.5: Added ‘Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. The veterinary medicinal product should not be administered by pregnant women. Personal protective equipment consisting of gloves should be worn when handling the product’
Section 4.6: Added ‘Occasionally a transient local reaction, such as scurf, mild exudation, alopecia, scab, erythema and pruritus may be observed at the application site following treatment. The product is bitter tasting and transient salivation may occasionally occur if the cat licks the application site immediately after treatment.
Section 4.7: Added ‘The safety of the product has not been established in cats during pregnancy, lactation or in animals intended for breeding.’
-
Posatex ear drops suspension for dogs
Active substance: Mometasone Furoate Monohydrate; Orbifloxacin; Posaconazole
Territory / Distribution category: GB POM-V
Authorisation holder: MSD Animal Health UK Limited
Change Category: Target species use; Packaging changes
Summary of change:
Section 3.9: Added ‘The inherent viscosity will result in a reduced delivery volume compared to the fill volume.’
Section 5.4: Pack sizes updated according to reduced delivery volume compared to the fill volume.
-
Vidalta 10 mg / 15 mg Prolonged-release Tablets for Cats
Active substance: Carbimazole
Territory / Distribution category: GB & NI POM-V
Authorisation holder: MSD Animal Health UK Limited
Change Category: Adverse reactions
Summary of change:
Section 3.6: There has been a change to the frequency of the adverse events; ‘ataxia’ and ‘pyrexia’ from ‘Very rare’ to ‘Rare’.
January 2025
New Authorisations
-
Poulvac Procerta HVT-IBD Concentrate and Solvent for Suspension for Injection for Chickens
Active substance: Cell-associated live recombinant turkey herpesvirus
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Zoetis UK Limited
NI SPC available from EU Union Product Database
Variations - food producing species
-
Altresyn 4 mg/ml Oral Solution for Pigs
Active substance: Altrenogest
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Ceva Animal Health Ltd
Change Category: Target species use
Summary of change:
Section 3.1: Pigs (sexually mature gilts and weaned primiparous sows).
-
Nuflor Minidose 450 mg/ml Solution for Injection for Cattle
Active substance: Florfenicol
Territory / Distribution category: GB & NI POM-V
Authorisation holder: MSD Animal Health UK Limited
Change Category: Target species use
Summary of change:
Section 3.2: 'metaphylaxis' has been substituted for 'prevention'.
-
Poulvac IB Primer [Chickens]; Poulvac IB QX Lyophilisate for Oculonasal Suspension for Chickens
Active substance: Infectious bronchitis virus
Territory / Distribution category: UK POM-V
Authorisation holder: Zoetis UK Limited
Change Category: Interactions and Overdose
Summary of change:
Section 4.8: Addition of associated use of Poulvac IB QX and Poulvac IB Primer.
-
PREVEXXION RN Concentrate and Solvent for Suspension for Injection; PREVEXXION RN+HVT Concentrate and Solvent for Suspension for Injection; PREVEXXION RN+HVT+IBD Concentrate and Solvent for Suspension for Injection
Active substance: Marek's disease virus, also for RN + HVT + IBD Turkey herpes virus
Territory / Distribution category: NI POM-V
Authorisation holder: Boehringer Ingelheim Vetmedica Gmbh
Change Category: Target species use
Summary of change:
Updated description of the pack-sizes of the vaccine concentrate and rewording of product information, also updated the solvent label adding the target species.
SPCs available from Union Product Database
-
Primopen 300 mg/ml Suspension for Injection for Cattle, Pigs and Horses
Active substance: Procaine Benzylpenicillin
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Fatro S.p.A.
Change Category: Contraindications, Special Warnings
Summary of change:
Section 3.4: Resistance in the target pathogens:
Elevated MIC values or bi-modal distribution profiles suggesting acquired resistance have been reported for the following bacteria:
- Glaesserella parasuis, Staphylococcus spp. causing MMA/PPDS, Streptococcus spp. and S. suis in pigs;
- Fusobacterium necrophorum causing metritis and Mannheimia haemolytica (only in some member states), as well as Bacteroides spp., Staphylococcus chromogenes, Actinobacillus lignieresii and Trueperella pyogenes in cattle.
Use of the veterinary medicinal product may result in a lack of clinical efficacy when treating infections caused by these bacteria.
-
Strangvac Suspension for Injection for Horses and Ponies
Active substance: Streptococcus equi
Territory / Distribution category: GB POM-V
Authorisation holder: Intervacc AB
Change Category: Adverse reactions
Summary of change:
Section 4.6: Added injection site swellings exceeding 8 cm.
-
Suvaxyn PRRS MLV Lyophilisate and Solvent for Suspension for Injection for Pigs
Active substance: Porcine respiratory and reproductive syndrome virus
Territory / Distribution category: GB POM-V
Authorisation holder: Zoetis UK Limited
Change catergory: Contraindications, Special warnings
Summary of change:
Section 4.7: Updated to allow use of the vaccine during lactation.
-
Vaxxitek HVT+IBD Concentrate and Solvent for Suspension for Injection [Chickens]
Active substance: Turkey herpesvirus
Territory / Distribution category: NI POM-V
Authorisation holder: Boehringer Ingelheim Vetmedica Gmbh
Change Category: Target sepcies use
Summary of change:
Updated description of the pack-sizes of the vaccine concentrate and rewording of product information, also updated the solvent label adding the target species.
SPC available from EU Union Product Database
Variations - Companion animal species
-
Alizin 30 mg/ml Solution for Injection [Dogs]
Active substance: Aglepristone
Territory / Distribution category: GB POM-V
Authorisation holder: Virbac
Change Category: Contraindications, Speial warnings; Adverse reactions.
Summary of change:
Section 4.5: Bitches that remain pregnant despite treatment (experiencing lack of efficacy) should be monitored, as viability of the puppies may be compromised.
Section 4.6: In rare cases of abortion failure (frequency > 1/10000 and < 1/1000) this could lead to dystocia or uterine rupture and very rarely to fatal outcome.
-
Clavusan 50 mg + 12.5 mg Tablets for Dogs and Cats; Clavusan 250 mg + 62.5 mg Tablets for Dogs and Cats; Clavusan 500 mg + 125 mg Tablets for Dogs
Active substance: Amoxicillin Trihydrate;
Potassium Clavulanate
Territory / Distribution category: NI-MRP POM-V
Authorisation holder: Alfasan Nederland B.V.
Change Category: Contraindications, Special warnings
Summary of change:
Section 3.5: An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG category) should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach.
-
Clomicalm Tablets for Dogs [Range]
Active substance: Clomipramine Hydrochloride
Territory / Distribution category: GB POM-V
Authorisation holder: Virbac
Change Category: Adverse reactions
Summary of change:
Section 4.6: Updated to add diarrhoea, mydriasis, aggression and convulsions adverse events with a “very rare” frequency.
-
Credelio 56 mg Chewable Tablets for Dogs (1.3–2.5 kg); Credelio 112 mg Chewable Tablets for Dogs (>2.5–5.5 kg); Credelio 225 mg Chewable Tablets for Dogs (>5.5–11 kg); Credelio 450 mg Chewable Tablets for Dogs (>11–22 kg); Credelio 900 mg Chewable Tablets for Dogs (>22–45 kg)
Active substance: Lotilaner
Territory / Distribution category: GB POM-V
Authorisation holder: Elanco GmbH
Change Category: Adverse reactions
Summary of change:
Section 4.6: Associated with a “very rare” frequency: Pruritus, bloody diarrhoea, urinary incontinence, inappropriate urination, polyuria and polydipsia.
-
Droncit Spot-on 20 mg Solution [Cats]
Active substance: Praziquantel
Territory / Distribution category: UK AVM-GSL
Authorisation holder: Vetoquinol UK Limited
Change Category: Adverse reactions
Summary of change:
Section 4.6: In very rare cases, a transient local reaction, such as scurf, mild exudation, alopecia (hair loss), scab, erythema (reddening), and pruritus (itching) may be observed at the application site following treatment.
-
Johnson’s One Dose Easy Wormer 230 mg/20 mg Film-coated Tablets for Cats and Kittens
Active substance: Praziquantel; Pyrantel Embonate
Territory / Distribution category: UK NFA-VPS
Authorisation holder: Vetoquinol UK Limited
Change Category: Name change
Summary of change:
Name change to Johnson’s Wormer Plus 230/20mg Film-coated Tablets for Cats & Kittens.
-
Neptra [Dogs]
Active substance: Florfenicol; Mometasone Furoate; Terbinafine hydrochloride
Territory / Distribution category: NI POM-V
Authorisation holder: Bayer Animal Health GmbH
Change Category: Contraindications, Special Warnings
Summary of change:
Section 3.5: The safety and efficacy of the veterinary medicinal product in cats has not been evaluated. Post-marketing surveillance shows that the use of the product in cats can be associated with neurological signs (including ataxia, Horner’s syndrome with protrusion of membrane nictitans, miosis, anisocoria), internal ear disorders (head tilt) and systemic signs (anorexia and lethargy). The use of the veterinary medicinal product in cats should therefore be avoided.
SPC available from EU Union Product Database
-
NexGard Combo Spot-on Solution for Cats [Range]
Active substance: Eprinomectin; Esafoxolaner; Praziquantel
Territory / Distribution category: GB POM-V
Authorisation holder: Boehringer Ingelheim Vetmedica GmbH
Change Category: Target species use
Summary of change:
Section 4.9: Remove the applicator from the package and point the rubber cap up. Pull back the plunger moderately (approximately 1 cm). Be careful not to take out the plunger. Further guidance regarding speed of application of the veterinary medicinal product was also added.
-
Phenoleptil Tablets for Dogs [Range]
Active substance: Phenobarbital
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Dechra Regulatory B.V.
Change Category: Target species use
Summary of change:
Section 3.9: Monitoring for increased side effects and for hepatic dysfunction should be conducted more regularly until stabilisation is confirmed.
Stabilisation protocols as for initiating treatments should be followed.
Withdrawal of therapy with Phenobarbital formulations should be made gradually to avoid precipitating an increase in the frequency of seizures.
-
Prinovox 40 mg + 4 mg Spot-on Solution for Small Cats and Ferrets; Prinovox 80 mg + 8 mg Spot-on Solution for Large Cats
Active substance: Imidacloprid; Moxidectin
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Elanco Europe Ltd
Change Category: Target species use
Summary of change:
Section 4.2: Addition of cat lung worm Troglostrongylus brevior (adults), with associated dosing and warnings.
-
Quantex 20 mg Spot-on Solution
Active substance: Praziquantel
Territory / Distribution category: UK AVM-GSL
Authorisation holder: Vetoquinol UK Limited
Change Category: Adverse reactions; Contraindications, special warnings
Summary of change:
Section 4.6: Occasionally a transient local reaction, such as scurf, mild exudation, alopecia (hair loss), scab, erythema (reddening) and pruritus (itching) may be observed at the application site following treatment.
As this product contains N-methyl pyrrolidone (NMP) as an excipient, the following was added to section 4.5: Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. The veterinary medicinal product should not be administered by pregnant women and women suspected of being pregnant. Personal protective equipment consisting of gloves and protective clothing should be worn when handling the veterinary medicinal product by women of childbearing age.
Additionally, 4.7: The safety of the veterinary medicinal product has not been established in cats during pregnancy, lactation, or in animals intended for breeding. Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Use only according to the benefit-risk assessment by the responsible veterinarian.
-
Stelfonta 1 mg/ml Solution for Injection for Dogs
Active substance: Tigilanol Tiglate
Territory / Distribution category: GB POM-V
Authorisation holder: QBiotics Netherlands B.V.
Change Category: Target species use
Summary of change:
Section 4.2: 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 cm3 in volume, and must be accessible to intratumoral injection.
-
YURVAC RHD Emulsion for Injection for Rabbits
Active substance: Recombinant RHDV2 virus capsid protein
Territory / Distribution category: NI POM-V
Authorisation holder: Laboratorios Hipra SA
Change Category: Target species use
Summary of change:
Section 3.2: Updated to include passive immunisation against RHD of the offspring of the does vaccinated with YURVAC RHD vaccine.
SPC available from EU Union Product Database
December 2024
New Authorisations
-
VAXXON ND CLONE, Lyophilisate and Solvent for Oculonasal Suspension, for Chicken
Active substance: Newcastle disease virus
Territory / Distribution category: NI POM-V
Authorisation holder: Vaxxinova International B.V.
SPC to follow
-
Vetoryl 20 mg Hard Capsules for Dogs
Active substance: Trilostane
Territory / Distribution category: NI POM-V
Authorisation holder: Dechra Regulatory B.V.
Variations - food producing species
-
Aivlosin 42.5 mg/g Oral Powder for Pigs; Aivlosin 42.5 mg/g Premix for Medicated Feeding Stuff for Pigs; Aivlosin 625 mg/g Granules for Use in Drinking Water for Pigs
Active substance: Tylvalosin
Territory / Distribution category: GB POM-V
Authorisation holder: Eco Animal Health Ltd
Change Category: Contraindications, Special warnings
Summary of change:
Section 4.7: No signs of adverse effects were observed in sows or their offspring when tylvalosin was administered orally and continuously for 195 days to sows, from before insemination to weaning, at an inclusion rate of 150 mg tylvalosin per kg water, corresponding to an average of 4.6 mg tylvalosin per kg body weight per day.
-
Flukanide 30 mg/ml Oral Suspension for Sheep
Active substance: Rafoxanide
Territory / Distribution category: UK POM-V
Authorisation holder: Univet Limited
Change Category: Target species use
Summary of change:
Section 4.2: For the treatment of liver fluke (Fasciola hepatica) infections (6-8 week immature and adult).
-
Gletvax 6 [Pigs]
Active substance: Clostridium perfringens;
Escherichia coli
Territory / Distribution category: UK POM-VPS
Authorisation holder: Zoetis UK Limited
Change Category: Contraindications, Special warnings; Adverse reactions
Summary of change:
Section 4.5: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Section 4.6: Hypersensitivity reactions may occur very rarely. Prompt subcutaneous administration of adrenaline may relieve the condition.
-
Multimin Solution for Injection for Cattle
Active substance: Copper, Manganese, Selenium, Zinc
Territory / Distribution category: NI POM-V
Authorisation holder: Warburton Technology Limited
Change Category: Adverse reactions; interactions and overdose
Summary of change:
Section 4.6: Mild pain is commonly observed during injection and can persist for up to eight hours after injection.
Local reactions at the injection site are very common and consist of transient moderate to severe swelling that can persist for approximately 7 days and evolves into induration estimated at less than 5 cm at palpation after 14 days.
Section 4.10: In one study, repeated overdosing (3 consecutive daily administrations) at 5.6x the recommended dose (i.e., 16.7x recommended dose) is associated with elevation of liver enzymes and hepatic centrilobular necrosis in six animals out of eight, with mortality in one animal.
-
Prascend 1 mg Tablets for Horses
Active substance: Pergolide
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Boehringer Ingelheim Animal Health UK Ltd
Change Category: Adverse reactions
Summary of change:
Section 3.6: Rare: Inappetence; anorexia; lethargy, Central nervous system disorder (e.g., depression and ataxia), diarrhoea, colic.
Very rare: sweating (sudation).
-
Procipen 300 mg/ml Suspension for Injection for Cattle Sheep and Pigs
Active substance: Procaine Benzylpenicillin
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Bimeda Animal Health Limited
Change catergory: Contraindications, Special warnings; Adverse reactions; Target species use
Summary of change:
Section 4.4: After absorption, benzylpenicillin poorly penetrates biological membranes (e.g., blood-brain barrier) since it is ionised and poorly lipid soluble. Use of the product for treatment of meningitis or CNS infections due to e.g., Streptococcus suis or Listeria monocytogenes may not be efficacious. Furthermore, benzylpenicillin penetrates mammalian cells poorly and hence this product may have little effect in treating intracellular pathogens e.g., Listeria monocytogenes.
Elevated MIC values or bi-modal distribution profiles suggesting acquired resistance have been reported for the following bacteria:
- Glaesserella parasuis, Staphylococcus spp. causing MMA/PPDS, Streptococcus spp. and S. suis in pigs;
- Fusobacterium necrophorum causing metritis and Mannheimia haemolytica (only in some member states), as well as Bacteroides spp., Staphylococcus chromogenes, Actinobacillus lignieresii and Trueperella pyogenes in cattle;
Use of the veterinary medicinal product may result in a lack of clinical efficacy when treating infections caused by these bacteria.
Section 4.6: Systemic toxic effects have been observed in young piglets, which are transient but can be potentially lethal, especially at higher doses.
Section 4.9: The treatment duration is 3 to 7 days.
The appropriate treatment duration should be chosen based on the clinical needs and individual recovery of the treated animal. Consideration should be given to the accessibility of the target tissue and characteristics of the target pathogen.
-
Solantel 200mg/ml Pour-On Solution for Cattle
Active substance: Closantel Sodium Dihydrate
Territory / Distribution category: GB & NI POM-VPS
Authorisation holder: Norbrook Laboratories Limited
Change Category: Contraindications, Special warnings
Summary of change:
Section 4.5: Due to the significant likelihood of cross-contamination of non-treated animals with this product due to grooming (licking), all animals in a group should be treated at the same time and treated animals should be kept separately from non-treated animals throughout the withdrawal period. Non-compliance with this recommendation may lead to residues violations or in very rare cases, it can lead to adverse events in non-treated animals.
-
Suvaxyn Circo Emulsion for Injection for Pigs
Active substance: Porcine circovirus-2
Territory / Distribution category: NI POM-V
Authorisation holder: Zoetis Belgium
Change Category: Contraindications, Special warnings
Summary of change:
Section 4.5: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
SPC available from EU Union Product Database
Variations - Companion animal species
-
Librela Solution for Injection for Dogs [Range]
Active substance: Bedinvetmab
Territory / Distribution category: GB POM-V
Authorisation holder: Zoetis UK Limited
Change Category: Contraindications, Special warnings
Summary of change:
Section 4.5: Change to terms with a frequency of rare: urinary incontinence, ataxia, lethargy, diarrhoea, emesis and anorexia; and with a frequency of very rare: seizure.
-
Mometamax Ultra Ear Drops Suspension for Dogs
Active substance: Gentamicin; Mometasone Furoate; Posaconazole
Territory / Distribution category: NI POM-V
Authorisation holder: MSD Animal Health UK Limited
Change Category: Target species use
Summary of change:
Section 3.9: Shake the bottle vigorously for 15 seconds before each use. Remove the cap. Insert the syringe tip into the adapter. Follow steps 1 to 5 of the dosing instructions.
SPC available EU Union Product Database
-
NexGard Combo spot-on solution for cats <2.5 kg; NexGard Combo spot-on solution for cats 2.5-7.5 kg
Active substance: Eprinomectin; Esafoxolaner; Praziquantel
Territory / Distribution category: NI POM-V
Authorisation holder: Boehringer Ingelheim Vetmedica GmbH
Change Category: Target species use
Summary of change:
Section 3.9:
3. Remove the applicator from the package and point the rubber cap up. Pull back the plunger moderately (approximately 1 cm). Be careful not to take out the plunger.
4. Twist and pull off the cap.
5. Part the hair on the midline of the neck, between the base of the skull and the shoulder blades until the skin is visible. Place the tip of the applicator on the skin and slowly apply the entire content directly onto the skin in one spot. The product should be applied to dry skin on an area where the cat cannot lick it off. In long hair breeds, special attention should be paid to apply the product onto the skin, and not on the hair to ensure optimal efficacy.
SPC available from EU Union Product Database
-
Profender 96 mg / 24 mg Spot-on Solution for Large Cats; Profender 60 mg / 15 mg Spot-on Solution for Medium Cats; Profender 30 mg / 7.5 mg Spot-on Solution for Small Cats
Active substance: Emodepside
Praziquantel
Territory / Distribution category: GB POM-V
Authorisation holder: Vetoquinol SA
Change Category: Adverse reactions
Summary of change:
The names have been updated to include the strength of the active substances.
Section 4.6: In the very rare category: anorexia, diarrhoea, lethargy, hyperactivity and hyperthermia.
-
StromEase 25 mg/ml Eye Drops, Solution for Dogs and Cats
Active substance: Acetylcysteine
Territory / Distribution category: NI POM-V
Authorisation holder: DOMES PHARMA
Change Category: Adverse reactions
Summary of change:
Section 4.6: Irritation or inflammation of the eye and/or its adnexa have been reported in very rare cases, especially blinking of the eyelids or even closure of the eye, eye redness or conjunctival oedema, particularly in dogs, according to pharmacovigilance data.
November 2024
Change of distribution category
The following product has a change of distribution category from POM-V to NFA-VPS.
-
Frontpro Chewable Tablets for Dogs (Range)
Active substance: Afoxolaner
Territory / Distribution category: GB NFA-VPS
Authorisation holder: Boehringer Ingelheim Vetmedica Gmbh
Change Category: Contraindications, Special warning
Summary of change:
Change of distribution category from POM-V to NFA-VPS, various relevant changes to the SPCs of these products.
Section 4.7: Updated to indicate that the products can be used in breeding, pregnant and lactating female dogs. However, the safety of the veterinary medicinal product has not been established in breeding males.
Link to SPC 11mg to follow
Link to SPC 28mg to follow
Link to SPC 68mg to follow
Link to SPC 136mg to follow
-
Lotilaner Elanco Chewable Tablets for Dogs (Range)
Active substance: Lotilaner
Territory / Distribution category: GB NFA-VPS
Authorisation holder: Elanco GmbH
Change Category: Distribution Category
Summary of change:
Due to a change in distribution category from POM-V to NFA-VPS, various relevant changes were made, as appropriate, to the SPCs of these products.
New Authorisations
-
Cirbloc M Hyo Emulsion for Injection for Pigs
Active substance: Mycoplasma hyopneumoniae, Porcine circovirus-2
Territory / Distribution category: NI POM-V
Authorisation holder: Ceva-Phylaxia Veterinary Biologicals Co. Ltd
SPC available from EU Union Product Database
-
Nobilis Multriva RT+IBm+ND+EDS Emulsion for Injection for Chickens
Active substance: Egg drop syndrome virus, Newcastle disease virus, Infectious bronchitis virus, Avian metapneumovirus
Territory / Distribution category: NI POM-V
Authorisation holder: Intervet International BV
SPC available from EU Union Product Database
-
ArthriCox 57 mg Chewable Tablets for Dogs; ArthriCox 227 mg Chewable Tablets for Dogs
Active substance: Firocoxib
Territory / Distribution category: NI POM-V
Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd
SPCs available from EU Union Product Database
-
Lotimil Plus 56.25 mg/2.11 mg Chewable Tablets (1.4–2.8 kg); Lotimil Plus 112.5 mg/4.22 mg Chewable Tablets (> 2.8–5.5 kg); Lotimil Plus 225 mg/8.44 mg Chewable Tablets (> 5.5–11 kg); Lotimil Plus 450 mg/16.88 mg Chewable Tablets (> 11–22 kg); Lotimil Plus 900 mg/33.75 mg Chewable Tablets (> 22–45 kg)
Active substance: Lotilaner, Milbemycin Oxime (A3 and A4)
Territory / Distribution category: GB POM-V
Authorisation holder: Elanco Europe Ltd
-
Meloxaid 5 mg/ml Solution for Injection for Dogs and Cats
Active substance: Meloxicam
Territory / Distribution category: GB & NI POM-V
Authorisation holder: EU Pharmaceuticals Ltd
-
Milbemycin Oxime Praziquantel Alfamed II 2.5 mg / 25.0 mg Chewable Tablets for Small Dogs and Puppies; Milbemycin Oxime Praziquantel Alfamed II 12.5 mg / 125.0 mg Chewable Tablets for Dogs; Milbemycin Oxime Praziquantel Alfamed II 25.0 mg / 250.0 mg Chewable Tablets for Large Dogs
Active substance: Milbemycin Oxime (A3 and A4), Praziquantel
Territory / Distribution category: GB POM-V
Authorisation holder: Alfamed
Variations - food producing species
-
Bimprocil 300 mg/ml Suspension for Injection for Cattle Sheep and Pigs
Active substance: Procaine Benzylpenicillin
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Bimeda Animal Health Limited
Change Category: Contraindications, Special warnings; Adverse reactions; Target species use
Summary of change:
Section 4.4: Updated special warnings relating to the use of the product for treating meningitis, infections of the central nervous system, or intracellular pathogens. Additional information added relating to bacterial species in which acquired resistance has been reported (see also updated section 5.1).
Section 4.6: Systemic toxic effects have been observed in young piglets, which are transient but can be potentially lethal, especially at higher doses.
Section 4.9: Treatment duration 3 to 7 days. Accordingly, the withdrawal periods in section 4.11 have been updated.
-
Bovilis Nasalgen-C Nasal Spray, Lyophilisate and Solvent for Suspension for Cattle
Active substance: Bovine coronavirus
Territory / Distribution category: NI POM-V
Authorisation holder: Intervet International B.V.
Change Category: Contraindications, Special warnings
Summary of change:
Section 3.7: Indication added to include use during pregnancy.
SPC available from EU Union Product Database
-
Loxicom 20 mg/ml Solution for Injection for Cattle, Pigs and Horses
Active substance: Meloxicam
Territory / Distribution category: GB POM-V
Authorisation holder: Norbrook Laboratories Limited
Change Category: Contraindications, Special warnings; Adverse reactions
Summary of change:
Section 4.5: This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.
Section 4.6: In cattle, only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.
-
Procactive 300 mg/ml Suspension for Injection for Cattle, Sheep and Pigs
Active substance: Procaine Benzylpenicillin
Territory / Distribution category: NI POM-V
Authorisation holder: Laboratorios SYVA S.A.U
Change Category: Target species use; Contraindications, Special warnings; Adverse reactions
Summary of change:
Sections 4.1, 4.2 and 4.5: Amended to remove the restriction of the use in pigs weighing 25 kgs or less.
Section 4.4: Updated special warnings relating to the use of the product for treating meningitis, infections of the central nervous system, or intracellular pathogens. Additional information added relating to bacterial species in which acquired resistance has been reported (see also updated section 5.1).
Section 4.6: Systemic toxic effects have been observed in young piglets, which are transient but can be potentially lethal, especially at higher doses.
Section 4.9: Treatment duration 3 to 7 days. Accordingly, the withdrawal periods in section 4.11 have been updated.
-
Vetimec 5 mg/ml Pour-on Solution for Cattle
Active substance: Ivermectin
Territory / Distribution category: GB & NI POM-VPS
Authorisation holder: Eco Animal Health Ltd
Change Category: Contraindications, Special warnings
Summary of change:
Section 4.5: Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. The veterinary medicinal product should not be administered by pregnant women and women suspected of being pregnant. Personal protective equipment consisting of gloves and protective clothing should be worn when handling the veterinary medicinal product by women of childbearing age.
Section 4.7: Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Use only according to the benefit-risk assessment by the responsible veterinarian.
Variations - Companion animal species
-
Bimprocil 300 mg/ml Suspension for Injection for Cattle Sheep and Pigs
Active substance: Procaine Benzylpenicillin
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Bimeda Animal Health Limited
Change Category: Contraindications, Special warnings; Adverse reactions; Target species use
Summary of change:
Section 4.4: Updated special warnings relating to the use of the product for treating meningitis, infections of the central nervous system, or intracellular pathogens. Additional information added relating to bacterial species in which acquired resistance has been reported (see also updated section 5.1).
Section 4.6: Systemic toxic effects have been observed in young piglets, which are transient but can be potentially lethal, especially at higher doses.
Section 4.9: Treatment duration 3 to 7 days. Accordingly, the withdrawal periods in section 4.11 have been updated.
-
Bovilis Nasalgen-C Nasal Spray, Lyophilisate and Solvent for Suspension for Cattle
Active substance: Bovine coronavirus
Territory / Distribution category: NI POM-V
Authorisation holder: Intervet International B.V.
Change Category: Contraindications, Special warnings
Summary of change:
Section 3.7: Indication added to include use during pregnancy.
SPC available from EU Union Product Database
-
Loxicom 20 mg/ml Solution for Injection for Cattle, Pigs and Horses
Active substance: Meloxicam
Territory / Distribution category: GB POM-V
Authorisation holder: Norbrook Laboratories Limited
Change Category: Contraindications, Special warnings; Adverse reactions
Summary of change:
Section 4.5: This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.
Section 4.6: In cattle, only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.
-
Procactive 300 mg/ml Suspension for Injection for Cattle, Sheep and Pigs
Active substance: Procaine Benzylpenicillin
Territory / Distribution category: NI POM-V
Authorisation holder: Laboratorios SYVA S.A.U
Change Category: Target species use; Contraindications, Special warnings; Adverse reactions
Summary of change:
Sections 4.1, 4.2 and 4.5: Amended to remove the restriction of the use in pigs weighing 25 kgs or less.
Section 4.4: Updated special warnings relating to the use of the product for treating meningitis, infections of the central nervous system, or intracellular pathogens. Additional information added relating to bacterial species in which acquired resistance has been reported (see also updated section 5.1).
Section 4.6: Systemic toxic effects have been observed in young piglets, which are transient but can be potentially lethal, especially at higher doses.
Section 4.9: Treatment duration 3 to 7 days. Accordingly, the withdrawal periods in section 4.11 have been updated.
-
Vetimec 5 mg/ml Pour-on Solution for Cattle
Active substance: Ivermectin
Territory / Distribution category: GB & NI POM-VPS
Authorisation holder: Eco Animal Health Ltd
Change Category: Contraindications, Special warnings
Summary of change:
Section 4.5: Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. The veterinary medicinal product should not be administered by pregnant women and women suspected of being pregnant. Personal protective equipment consisting of gloves and protective clothing should be worn when handling the veterinary medicinal product by women of childbearing age.
Section 4.7: Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Use only according to the benefit-risk assessment by the responsible veterinarian.