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.
October 2024
New Authorisations
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DIVENCE IBR MARKER LIVE Lyophilisate and Solvent for Emulsion for Injection
Active substance: Infectious bovine rhinotracheitis virus
Territory / Distribution category: GB POM-V
Authorisation holder: Laboratorios Hipra SA
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DIVENCE PENTA Lyophilisate and Solvent for Emulsion for Injection
Active substance: Bovine respiratory syncytial virus, Infectious bovine rhinotracheitis virus, Bovine parainfluenza virus 3, E2 recombinant protein, E2 recombinant protein
Territory / Distribution category: GB POM-V
Authorisation holder: Laboratorios Hipra SA
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Gamrozyne 150 mg/ml Solution for Injection for Cattle, Sheep and Pigs
Active substance: Gamithromycin
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Bimeda Animal Health Limited
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Audolyn Ear Drops and Cutaneous Suspension for Cats and Dogs
Active substance: Miconazole nitrate, Polymyxin B sulphate, Prednisolone acetate
Territory / Distribution category: GB & NI POM-V
Authorisation holder: EU Pharmaceuticals Ltd
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Beaphar Insecticidal Shampoo for Dogs, 10mg/g
Active substance: Permethrin (Cis:Trans 40:60)
Territory / Distribution category: GB & NI AVM-GSL
Authorisation holder: Pets Choice Limited
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Earolan Ear Drops and Cutaneous Suspension for Cats and Dogs
Active substance: Prednisolone acetate, Miconazole nitrate, Polymyxin B sulphate
Territory / Distribution category: GB & NI POM-V
Authorisation holder: EU Pharmaceuticals Ltd
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Otisur Ear Drops and Cutaneous Suspension for Cats and Dogs
Active substance: Prednisolone acetate, Polymyxin B sulphate, Miconazole nitrate
Territory / Distribution category: GB & NI POM-V
Authorisation holder: EU Pharmaceuticals Ltd
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Refordog 40 mg/200 mg Spot-on Solution for Dogs over 1.5 kg up to 4 kg; Refordog 100 mg/500 mg Spot-on Solution for Dogs over 4 kg up to 10 kg; Refordog 250 mg/1250 mg Spot-on Solution for Dogs over 10 kg up to 25 kg; Refordog 400 mg/2000 mg Spot-on Solution for Dogs over 25 kg up to 40 kg; Refordog 600 mg /3000 mg Spot-on Solution for Dogs over 40 kg up to 60 kg
Active substance: Imidacloprid, Permethrin (Cis:Trans 40:60)
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Vetpharma Animal Health, S.L
Variations - food producing species
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Bovilis Rotavec Corona Emulsion for Injection for Cattle
Active substance: Bovine coronavirus, Bovine rotavirus, Escherichia coli
Territory / Distribution category: GB & NI POM-VPS
Authorisation holder: MSD Animal Health UK Limited
Change Category: Administration route
Summary of change:
Added subcutaneous route of administration as an additional route and to allow the associated non-mixed use of Bovilis Rotavec Corona and Bovilis Cryptium.
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Dalmazin, 75 Micrograms/ml, Solution for Injection for Cattle, Buffaloes and Pigs
Active substance: Cloprostenol
Territory / Distribution category: GB POM-V
Authorisation holder: Fatro S.p.A.
Change Category: Target Species Use
Summary of change:
Section 4.1: Addition of buffaloes (females) as a target species.
Section 4.2: Cattle and buffalo: Induction and synchronisation of oestrus and ovulation in combination with GnRH or GnRH analogue, with or without progesterone, as part of fixed time artificial insemination (FTAI) protocols.
Induction of parturition after day 270 of gestation in cattle and within 10-15 days before expected calving in buffaloes.
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Flordofen 300 mg/ml Solution for Injection for Cattle and Pigs
Active substance: Florfenicol
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Dopharma Research B.V.
Change Category: Contraindications, Special Warnings
Summary of change:
Section 4.5/3.5: Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Women of childbearing age, pregnant women or women suspected of being pregnant should use the veterinary medicinal product with serious caution to avoid accidental self-injection.
Section 4.7/3.7: The safety of the veterinary medicinal product has not been established in cattle and pigs 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.
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PREVEXXION RN+HVT+IBD Concentrate and Solvent for Suspension for Injection [Chickens]
Active substance: Marek's disease virus,
Turkey herpesvirus
Territory / Distribution category: GB POM-V
Authorisation holder: Boehringer Ingelheim Vetmedica Gmbh
Change Category: Administration Route
Summary of change:
Addition of a in ovo as a new route of administration.
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Procactive 300 mg/ml Suspension for Injection for Cattle and Pigs
Active substance: Procaine Benzylpenicillin
Territory / Distribution category: GB POM-V
Authorisation holder: Laboratorios SYVA S.A.U
Change Category: Contrindications, special warnings; target species use; withdrawal period
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 4.9: 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.
Section 4.11 Withdrawal periods:
Pigs: Meat and offal: 6 days for treatment duration 3-5 days, 8 days for treatment duration 6-7 days.
Cattle: Meat and offal: 6 days for treatment duration 3-5 days, 8 days for treatment duration 6-7 days.
Section 5.1: Enterobacterales, Bacteroides fragilis, most Campylobacter spp., Nocardia spp. and Pseudomonas spp. as well as beta-lactamase–producing Staphylococcus spp. are resistant.
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Rispoval 2 / BRSV + Pi3 Lyophilisate and Solvent for Suspension for Injection for Cattle
Active substance: Bovine parainfluenza virus 3, Bovine respiratory syncytial virus
Territory / Distribution category: NI POM-V
Authorisation holder: Zoetis UK Limited
Change Category: Target species use
Summary of change:
Section 3.2 & 3.9: The introduction of an additional vaccination scheme and claim against BRSV and Pi-3 for calves which have received a booster vaccination of Rispoval 2 at 12 weeks of age following initial vaccination with Rispoval RS at nine days.
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Rispoval RS+PI3 Intranasal nasal spray lyophilisate and solvent for suspension for cattle
Active substance: Bovine parainfluenza virus 3, Bovine respiratory syncytial virus
Territory / Distribution category: NI POM-V
Authorisation holder: Zoetis UK Limited
Change Category: Target species use
Summary of change:
Section 3.2 & 3.9: The introduction of an additional vaccination scheme and claim against BRSV and Pi-3 for calves which have received a booster vaccination of Rispoval 2 at 12 weeks of age following initial vaccination with Rispoval RS at nine days.
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Suvaxyn PRRS MLV Lyophilisate and Solvent for Suspension for Injection for Pigs
Active substance: Porcine respiratory and reproductive syndrome virus
Territory / Distribution category: NI POM-V
Authorisation holder: Zoetis Belgium
Change Category: Contraindications, Special warnings
Summary of change:
Section 4.7: Removal of warning related to the absence of safety data for use of the vaccine during lactation.
SPC availabel from the EU Union Product Database
Variations - Companion animal species
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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: GB POM-V
Authorisation holder: Boehringer Ingelheim Vetmedica GmbH
Change Category: Target species use
Summary of change:
Section 4.2: Immediate and persistent tick killing activity against Ixodes hexagonus for one month. Persistent tick killing activity from 7 days to five weeks against Rhipicephalus sanguineus.
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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 3.2: Persistent tick killing activity from 7 days to five weeks after treatment against Rhipicephalus sanguineus. Persistent tick killing activity from 7 days to four weeks after treatment against Ixodes hexagonus.
SPCs available from the EU Union Product Database
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StromEase 25 mg/ml Eye Drops, Solution for Dogs and Cats
Active substance: Acetylcysteine
Territory / Distribution category: GB 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 following use of the medicinal product. In very rare cases, blinking of the eyelids or even transient closure of the eye, eye redness or conjunctival oedema have been reported, particularly in dogs, according to pharmacovigilance data.
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Vetoryl 5 mg / 10 mg / 30 mg / 60 mg / 120 mg Hard Capsules for Dogs
Active substance: Trilostane
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Dechra Limited
Change Category: Target species use; adverse reactions; Interactions and Overdose
Summary of change:
Section 3.6: Reclassification of the adverse event 'weakness' from very rare to rare.
Section 3.9: A dose adjustment may be necessary if the dog is swapped from Vetoryl hard capsules to Vetoryl chewable tablets, or vice versa, as a strict interchangeability between the two products cannot be assured, as some dogs may respond differently to the change in pharmaceutical form.
Section 3.10: There were no mortalities following chronic administration at 32 mg/kg to healthy dogs, however mortalities did occur after repeated administration of higher doses (40–67 mg/kg/day) to healthy dogs.
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Johnson's Easy Spot-On Solution Wormer for Cats & Kittens 20mg
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: 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 should be worn when handling the veterinary medicinal product by women of childbearing age.
Section 4.6: Cats and kittens: 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.
Section 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.
September 2024
New Authorisations
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Bovimox LA 100 mg/ml Solution for Injection for Cattle
Active substance: Moxidectin
Territory / Distribution category: GB & NI POM-VPS
Authorisation holder: EU Pharmaceuticals Ltd
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Moxodex LA 100 mg/ml Solution for Injection for Cattle
Active substance: Moxidectin
Territory / Distribution category: GB & NI POM-VPS
Authorisation holder: EU Pharmaceuticals Ltd
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Ridamec LA 100 mg/ml Solution for Injection for Cattle
Active substance: Moxidectin
Territory / Distribution category: GB & NI POM-VPS
Authorisation holder: EU Pharmaceuticals Ltd
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Chanear Ear Drops and Cutaneous Suspension for Cats and Dogs
Active substance: Miconazole nitrate, Prednisolone acetate, Polymyxin B sulphate
Territory / Distribution category: GB & NI POM-V
Authorisation holder: EU Pharmaceuticals Ltd
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Coxatab 25 mg / 100 mg / 225 mg Chewable Tablets for Dogs
Active substance: Firocoxib
Territory / Distribution category: GB POM-V
Authorisation holder: CP Pharma Handelsgesellschaft mbH
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Marbotis 3mg/ml + 10mg/ml + 1mg/ml Ear Drops, Suspension for Dogs
Active substance: Dexamethasone, Clotrimazole, Dexamethasone acetate, Marbofloxacin
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Vet-Agro Multi-Trade Company Sp. z o.o.
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YURVAC RHD Emulsion for Injection for Rabbits
Active substance: Recombinant RHDV2 virus capsid protein
Territory / Distribution category: GB POM-V
Authorisation holder: Laboratorios Hipra SA
Variations - food producing species
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Cydectin 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 (GB) and 3.4 (NI): Psoroptes ovis is an extremely contagious external parasite of sheep and cattle. To ensure complete control, great care must be taken to avoid re-infestation, as mites may be viable for up to 15 days off the animal. It is important that all animals which have been in contact with infected ones are treated with an appropriate product. Contact between treated, infected and untreated herds must be avoided until at least seven days after treatment.
Resistance to moxidectin has been reported in Psoroptes ovis scab mites in sheep and in cattle. Cases of side-resistance with other macrocyclic lactones (ivermectin and doramectin) have been reported as well. The use of this product should take into account local information about susceptibility of the target parasites, where available.
Section 4.6 (GB) and 3.6 (NI): There has been a change to the frequency of the adverse event ‘neurological disorder (such as collapse, convulsion, paralysis)’ to ‘very rare’, with a related note added that severe reactions may be fatal.
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Qualimec 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
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Posatex, Ear Drops Suspension for Dogs
Active substance: Mometasone Furoate, Orbifloxacin, Posaconazole
Territory / Distribution category: NI POM-V
Authorisation holder: Intervet International BV
Change Category:
Summary of change:
Section 3.9: Posatex is a viscous suspension. The inherent viscosity will result in a reduced delivery volume compared to the fill volume (see section 5.4). Further information on delivery volume in relation to fill volume for each pack size are provided in section 5.4.
SPC available from EU Union Product Database
August 2024
New Authorisations
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Bimacox 2.5 mg/ml Oral Suspension for Lambs and Calves
Active substance: Diclazuril
Territory / Distribution category: NI POM-VPS
Authorisation holder: Bimeda Animal Health Limited
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Bimacox 2.5 mg/ml Oral Suspension for Sheep and Cattle
Active substance: Diclazuril
Territory / Distribution category: GB POM-VPS
Authorisation holder: Bimeda Animal Health Limited
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Bovilis Cryptium Emulsion for Injection for Cattle
Active substance: Cryptosporidium parvum
Territory / Distribution category: GB POM-V
Authorisation holder: MSD Animal Health UK Limited
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Deltamethrin Virbac 10 mg/ml Pour-on Solution for Cattle and Sheep
Active substance: Deltamethrin
Territory / Distribution category: GB POM-VPS
Authorisation holder: VIRBAC
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DIVENCE IBR MARKER LIVE Lyophilisate and Solvent for Suspension for Injection [Cattle]
Active substance: Infectious bovine rhinotracheitis virus
Territory / Distribution category: NI POM-V
Authorisation holder: Laboratorios Hipra SA
Link to SPC to follow
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Doramax 10 mg/ml Solution for Injection for Cattle and Sheep
Active substance: Doramectin
Territory / Distribution category: GB & NI POM-VPS
Authorisation holder: C&H Generics Ltd
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DrySeal 2.6 g Intramammary Suspension for Cattle
Active substance: Bismuth subnitrate
Territory / Distribution category: GB POM-V
Authorisation holder: Elanco GmbH, NI
Elanco Europe Ltd, GB
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Flunex 50 mg/ml Solution for Injection for Cattle, Pigs and Horses
Active substance: Flunixin
Territory / Distribution category: NI POM-V
Authorisation holder: Livisto Int'l, S.L.
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Triquest 333 mg/ml + 67 mg/ml Oral Suspension for Horses
Active substance: Trimethoprim, Sulfadiazine
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Alfasan Nederland B.V.
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Cepfenicol 5 mg/ml Eye Drops, Solution for Dogs and Cats
Active substance: Chloramphenicol
Territory / Distribution category: NI POM-V
Authorisation holder: CP Pharma Handelsgesellschaft mbH
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Cepfenidex 2 mg/ml + 1 mg/ml Eye Drops, Solution for Dogs and Cats
Active substance: Chloramphenicol, Dexamethasone
Territory / Distribution category: NI POM-V
Authorisation holder: CP Pharma Handelsgesellschaft mbH
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Daxocox 140 mg Tablets for Dogs; Daxocox 200 mg Tablets for Dogs
Active substance: Enflicoxib
Territory / Distribution category: NI POM-V
Authorisation holder: Ecuphar NV
Link to SPC 140 mg to follow
Link to SPC 200 mg to follow
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Fluoxevet 32 mg, Tablets for Dogs
Active substance: Fluoxetine
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Domes Pharma
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Trilocur 50 mg/ml Oral Suspension for Dogs
Active substance: Trilostane
Territory / Distribution category: GB POM-V
Authorisation holder: Emdoka bvba
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Trilorale 50 mg/ml Oral Suspension for Dogs
Active substance: Trilostane
Territory / Distribution category: GB POM-V
Authorisation holder: Axience
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Vetoryl Flavoured 20 mg Tablets for Dogs; Vetoryl Flavoured 30 mg Tablets for Dogs; Vetoryl Flavoured 60 mg Tablets for Dogs; Vetoryl Flavoured 120 mg Tablets for Dogs
Active substance: Trilostane
Territory / Distribution category: GB POM-V
Authorisation holder: Dechra Regulatory B.V.
Variations - food producing species
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Dalmazin, 75 Micrograms/ml, Solution for Injection for Cattle, Buffaloes and Pigs
Active substance: Cloprostenol
Territory / Distribution category: NI POM-V
Authorisation holder: Fatro S.p.A.
Change Category: Target species use
Summary of change:
Section 3.1: Addition of buffaloes (females) as a target species.
Section 3.2: Cattle and buffalo; Induction and synchronisation of oestrus and ovulation in combination with GnRH or GnRH analogue, with or without progesterone, as part of fixed time artificial insemination (FTAI) protocols.
Induction of parturition after day 270 of gestation in cattle and within 10-15 days before expected calving in buffaloes.
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Oxtra DD 100 mg/ml Solution for Injection for Cattle, Sheep, Pigs, Horses, Dogs and Cats
Active substance: Oxytetracycline
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Fatro S.p.A.
Change Category: Target species use
Summary of change:
Section 4.12 (GB) and 3.12 (NI): Change to the withdrawal period for cattle and sheep milk when using the 24-hour dosage regimen: cattle milk 72 hours, sheep milk 120 hours.
July 2024
New Authorisations
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Dorimec 10 mg/ml Solution for Injection for Cattle and Sheep
Active substance: Doramectin
Territory / Distribution category: GB & NI POM-VPS
Authorisation holder: C&H Generics Ltd
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Gastazole 370 mg/g Oral Paste for Horses
Active substance: Omeprazole
Territory / Distribution category: GB & NI POM-V
Authorisation holder: EU Pharmaceuticals Ltd
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Mastic Seal 2.6 Intramammary Suspension for Cattle
Active substance: Bismuth subnitrate
Territory / Distribution category: NI POM-V
Authorisation holder: Bioveta, a.s.
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Nobilis Multriva RT+IBm+ND+Gm+REOm Emulsion for Injection for Chickens
Active substance: Avian metapneumovirus, Infectious bronchitis virus, Newcastle disease virus, Infectious bursal disease virus, Avian reovirus
Territory / Distribution category: NI POM-V
Authorisation holder: Intervet International BV
SPC available on the EU Union Product Database
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Omepratex 370 mg/g Oral Paste for Horses
Active substance: Omeprazole
Territory / Distribution category: GB & NI POM-V
Authorisation holder: EU Pharmaceuticals Ltd
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Rokopig Entero Emulsion for Injection [Pigs]
Active substance: Clostridium perfringens, Porcine rotavirus, Escherichia coli
Territory / Distribution category: NI POM-V
Authorisation holder: Bioveta, a.s.
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Coxatab 57 mg Chewable Tablets for Dogs
Active substance: Firocoxib
Territory / Distribution category: GB POM-V
Authorisation holder: CP Pharma Handelsgesellschaft mbH
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Fatrobendan 1.25 / 5 / 10 mg, Chewable Tablets for Dogs
Active substance: Pimobendan
Territory / Distribution category:NI POM-V
Authorisation holder: Fatro S.p.A.
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Milpro Chewy 2.5 mg / 25.0 mg Chewable Tablets for Small Dogs and Puppies; Milpro Chewy 12.5 mg / 125.0 mg Chewable Tablets for Dogs; Milpro Chewy 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: VIRBAC
Praziquantel
Link to SPC 12.5 mg / 125.0 mg
Link to SPC 25.0 mg / 250.0 mg
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Otomicol Ear Drops and Cutaneous Suspension for Dogs, Cats and Guinea Pigs
Active substance: Miconazole nitrate, Prednisolone acetate, Polymyxin B sulphate
Territory / Distribution category: NI POM-V
Authorisation holder: KRKA, d.d., Novo mesto
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Urixine 40 mg/ml Syrup for Dogs
Active substance: Phenylpropanolamine
Territory / Distribution category: NI POM-V
Authorisation holder: Laboratorios Karizoo S.A
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Vetoryl 20 / 30 / 60 / 120 mg Chewable Tablets for Dogs
Active substance: Trilostane
Territory / Distribution category: NI POM-V
Authorisation holder: Dechra Regulatory B.V.
Variations - food producing species
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Cydectin 10% LA Solution for Injection for Cattle
Active substance: Moxidectin
Territory / Distribution category: GB & NI POM-VPS
Authorisation holder: Zoetis UK Limited
Change Category: Target species use; Contraindications, special warnings;
Summary of change; Adverse reactions
NI SPC Section 3.4 & GB 4.4: Unnecessary use of antiparasitics or use deviating from the instructions given in the SPC may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the product should be based on confirmation of the parasitic species and burden, or of the risk of infestation based on its epidemiological features, for each individual herd.
Care should be taken to avoid the following practices, because they increase the risk of development of resistance and could ultimately result in ineffective therapy: Too frequent and repeated use of anthelmintics from the same class, over an extended period of time; Repeated use for an extended period, particularly when using the same class of substances, increases the risk of resistance development. Within a herd, maintenance of susceptible refugia is essential to reduce that risk. Systematically applied interval-based treatment and treatment of a whole herd should be avoided. Instead, if feasible, only selected individual animals or subgroups should be treated (targeted selective treatment). This should be combined with appropriate husbandry and pasture management measures. Guidance for each specific herd should be sought from the responsible veterinarian. Underdosing which may due to underestimation of body weight, misadministration of the veterinary medicinal product, or lack of calibration of the dosing device (if any).
Resistance to moxidectin has been reported in Cooperia spp. and Ostertagia spp. in cattle. Psoroptes ovis is an extremely contagious external parasite of sheep and cattle. To ensure complete control, great care must be taken to avoid reinfestation, as mites may be viable for up to 15 days off the animal. It is important that all animals which have been in contact with infected ones are treated with an appropriate product. Contact between treated, infected and untreated herds must be avoided until at least seven days after treatment. Resistance to moxidectin has been reported in Psoroptes ovis scab mites in sheep and in cattle. Cases of side-resistance with other macrocyclic lactones (ivermectin and doramectin) have been reported as well. The use of this product should take into account local information about susceptibility of the target parasites, where available.
NI SPC Section 3.5 & GB 4.5: To prevent a possible anaphylactic type reaction, do not inject the product intravenously.
NI SPC Section 3.6 & GB 4.6: Hypersensitivity reaction, Neurological disorder (such as collapse, convulsion, paralysis, blindness) have added to this section in the Very rare category. If a hypersensitivity reaction occurs, a symptomatic treatment should be applied. Severe neurological reactions may be fatal.
NI SPC Section 3.9 & GB 4.9: Underdosing could result in ineffective use and may favour resistance development. To ensure administration of a correct dosage, body weight should be determined as accurately as possible. If animals are to be treated collectively, reasonably homogeneous groups should be set up, and all animals of a group should be dosed at the rate corresponding to the heaviest one. Accuracy of the dosing device should be thoroughly checked.
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Florfenikel 300 mg/ml Solution for Injection for Cattle and Pigs
Active substance: Florfenicol
Territory / Distribution category: NI POM-V
Authorisation holder: Kela nv
Change Category: Contraindications, Special warnings
Summary of change:
Section 4.5: The use of this veterinary medicinal product may pose a risk for terrestrial plants, cyanobacteria and groundwater organisms.
Section 6.6: The veterinary medicinal product should not enter water courses as florfenicol may be dangerous for fish and other aquatic organisms.
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Flubenmix 5%, 50 mg/g Premix for Medicated Feeding Stuff
Active substance: Flubendazole
Territory / Distribution category: GB & NI POM-VPS
Authorisation holder: Kernfarm B.V.
Change category: Target species use
Summary of change:
Section 1: Name change to Kernfarm Flubenmix 5%, 50 mg/g Premix for Medicated Feeding Stuff
NI SPC Section 3.2 & GB 4.2: The product is registered for the treatment of adult stages of the helminth species, and, in case of Ascaridia galli, all intestinal larval stages (L2, L3 and L4) and adult stages.
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Meflosyl 5% Solution for Injection [Horses]
Active substance: Flunixin
Territory / Distribution category: UK POM-V
Authorisation holder: Zoetis UK Limited
Change category: Contraindications, Special warnings
Summary of change:
Section 4.5: Flunixin is toxic to avian scavengers. Do not administer to animals susceptible to enter wild fauna food chain. In case of death or sacrifice of treated animals, ensure that they are not made available to wild fauna.
Section 4.6: added that in very rare cases allergic reactions (anaphylaxis) may occur after administration of the veterinary medicinal product.
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Mycoflor, 300 mg/ml Solution for Injection for Cattle and Pigs
Active substance: Florfenicol
Territory / Distribution category: GB & NI POM-V
Authorisation holder: SP Veterinaria, S.A.
Change category: Contraindications, Special warnings
Summary of change:
Section 4.5: The use of this veterinary medicinal product may pose a risk for terrestrial plants, cyanobacteria and groundwater organisms.
Section 6.6: The veterinary medicinal product should not enter water courses as florfenicol may be dangerous for fish and other aquatic organisms.
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Selectan 300 mg/ml Solution for Injection for Cattle and Swine
Active substance: Florfenicol
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Laboratorios Hipra SA
Change category: Contraindications, Special warnings
Summary of change:
Section 4.5: The use of this veterinary medicinal product may pose a risk for terrestrial plants, cyanobacteria and groundwater organisms.
Section 6.6: The veterinary medicinal product should not enter water courses as florfenicol may be dangerous for fish and other aquatic organisms.
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Suiseng Coli / C Suspension for Injection for Pigs; Suiseng Diff/A Suspension for Injection for Pigs
Active substance: Clostridioides difficile;
Clostridium perfringens
Territory / Distribution category: GB POM-V
Authorisation holder: Laboratorios Hipra SA
Change category: Target species use; Adverse reactions; Interactions & Overdose
Summary of change:
To add the associated use of Suiseng Coli/C with Suiseng Diff/A. SPC update to sections 4.6 (Suiseng Coli/C), 4.8, 4.9. 6.2, 6.3 and 6.5 (Suiseng Diff/A).
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Sureseal 2.6 g Intramammary Suspension for Cattle
Active substance: Bismuth Subnitrate
Territory / Distribution category: GB POM-V
Authorisation holder: Norbrook Laboratories Limited
Change category: Contraindications, Special warnings; Adverse reactions; Target species use
Summary of change:
Section 4.5: Since the product does not have antimicrobial activity, in order to minimise the risk of acute mastitis due to poor infusion technique and lack of hygiene (see section 4.6), it is crucial to follow the aseptic technique of administration described in section 4.9.
Section 4.6: Acute mastitis has been reported very rarely after use of this product, primarily due to the poor infusion technique and lack of hygiene. Please refer to sections 4.5 and 4.9 regarding the importance of aseptic technique.
Section 4.9: Care must be taken not to introduce pathogens into the teat in order to reduce the risk of post-infusion mastitis (aseptic technique). It is essential that the teat is thoroughly cleaned and disinfected, with surgical spirit or alcohol-impregnated wipes. The teats should be wiped until the wipes are no longer visibly dirty. Teats should be allowed to dry prior to infusion. Infuse aseptically and avoid contamination of the syringe nozzle. Following infusion it is advisable to use an appropriate teat dip or spray.
-
Ubroseal Blue Dry Cow 2.6 g Intramammary Suspension for Cattle
Active substance: Bismuth Subnitrate
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Univet Ltd
Change category: Target species use; Contraindications, Special warnings; Adverse reactions
Summary of change:
Section 4.2: In cows considered likely to be free of sub-clinical mastitis, the veterinary medicinal product can be used on its own in dry cow management and mastitis control
Section 4.5: The disinfecting towels provided with the intramammary veterinary medicinal product contain isopropyl alcohol. Wear protective gloves if skin irritation due to isopropyl alcohol is known or suspected. Avoid contact with eyes because isopropyl alcohol can cause eye irritation.
Section 4.6: adverse event Acute mastitis added in the Very rare category.
Section 4.9: It is essential that the teat is thoroughly cleaned and disinfected, with surgical spirit or alcohol-impregnated disinfecting towels. The teats should be wiped until the disinfecting towels are no longer visibly dirty. Teats should be allowed to dry prior to infusion. Infuse aseptically and take care to avoid contamination of the syringe nozzle. Following infusion it is advisable to use an appropriate teat dip or spray.
Variations - companion animal species
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Fortekor 2.5 mg Tablets for Cats and Dogs; Fortekor Flavour 5 mg Tablets for Cats and Dogs; Fortekor Flavour 20 mg Tablets for Dogs
Active substance: Benazepril Hydrochloride
Territory / Distribution category: NI POM-V
Authorisation holder: Elanco Europe Ltd
Change category: Adverse reactions
Summary of change:
Section 3.6 for dogs only: Adverse events Diarrhoea, Vomiting, Anorexia and Fatigue added to the Rare category, and Elevated creatinine and Incoordination to the Very Rare.
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Thyronorm 5 mg/ml Oral Solution for Cats
Active substance: Thiamazole
Territory / Distribution category: GB POM-V
Authorisation holder: Norbrook Laboratories Limited
Change category: Target species use
Summary of change:
Section 4.9: If, for reasons of compliance, once daily dosing is preferable, then this is acceptable, although a 2.5mg dose (=0.5ml of the product) given twice daily may be more efficacious in the short term.
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Vetoryl 20 / 30 / 60 / 120 mg Chewable Tablets for Dogs
Active substance: Trilostane
Territory / Distribution category: NI POM-V
Authorisation holder: Dechra Regulatory B.V
Summary of change:
Change in pharmaceutical form (hard capsule to chewable tablets) and new 20 mg strength available.
June 2024
New Authorisations
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Amphen 200 mg/ml Suspension for Use in Drinking Water for Pigs
Active substance: Florfenicol
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Huvepharma NV
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DIVENCE PENTA Lyophilisate and Solvent for Emulsion for Injection [Cattle]
Active substance: Infectious bovine rhinotracheitis virus, Bovine parainfluenza virus 3, Bovine respiratory syncytial virus, E2 recombinant protein
Territory / Distribution category: NI POM-V
Authorisation holder: Laboratorios Hipra SA
SPC available from EU Union Product Database
-
DIVENCE TETRA Lyophilisate and Solvent for Emulsion for Injection [Cattle]
Active substance: Bovine respiratory syncytial virus, Bovine parainfluenza virus 3, E2 recombinant protein
Territory / Distribution category: NI POM-V
Authorisation holder: Laboratorios Hipra SA
SPC available from EU Union Product Database
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Innovax-ND-H5 Concentrate and Solvent for Suspension for Injection for Chickens
Active substance: Turkey herpesvirus
Territory / Distribution category: NI POM-V
Authorisation holder: Intervet International BV
SPC available from EU Union Product Database
-
Pyrocam 20 mg/ml Solution for Injection for Cattle, Pigs and Horses
Active substance: Meloxicam
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Huvepharma NV
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RESPIVAC TRT Lyophilisate for Oculonasal Suspension/Use in Drinking Water for Chickens
Active substance: Avian metapneumovirus
Territory / Distribution category: NI POM-V
Authorisation holder: Laboratorios Hipra SA
SPC available from EU Union Product Database
-
Rotacur Emulsion for Injection for Cattle
Active substance: Bovine rotavirus, Bovine coronavirus, Escherichia coli
Territory / Distribution category: GB POM-VPS
Authorisation holder: Forte Healthcare Limited
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Alcort 0.584 mg/ml Cutaneous Spray, Solution [Dogs]
Active substance: Hydrocortisone aceponate
Territory / Distribution category:NI POM-V
Authorisation holder: Nextmune Italy S.R.L.
SPC available from EU Union Product Database
-
Bravecto 150 mg/ml Powder and Solvent for Suspension for Injection for Dogs
Active substance: Fluralaner
Territory / Distribution category: GB POM-V
Authorisation holder: MSD Animal Health UK Limited
-
Eluracat 20 mg/ml Oral Solution for Cats
Active substance: Capromorelin tartrate
Territory / Distribution category: GB POM-V
Authorisation holder: Elanco GmbH
-
Meloxicam Ceva 0.5 mg/ml Oral Suspension for Cats; Meloxicam Ceva 1.5 mg/ml Oral Suspension for Dogs; Meloxicam Ceva 5 mg/ml Solution for Injection for Dogs and Cats
Active substance: Meloxicam
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Ceva Animal Health Ltd
Link to GB SPC 0.5mg/ml for cats
Link to NI SPC 0.5mg/ml for cats
Link to GB SPC 1.5mg/ml for dogs
Link to NI SPC 1.5mg/ml for dogs
Link to GB SPC 5mg/ml for dogs and cats
Link to NI SPC 5mg/ml for dogs and cats
-
Milbemycin Oxime Praziquantel Alfamed 2.5 mg / 25.0 mg Chewable Tablets for Small Dogs and Puppies; Milbemycin Oxime Praziquantel Alfamed 12.5 mg / 125.0 mg Chewable Tablets for Dogs
Active substance: Milbemycin Oxime (A3 and A4), Praziquantel
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Alfamed
Link to GB SPC 2.5mg / 25.0 mg
Link to NI SPC 2.5mg / 25.0 mg
Link to GB SPC 12.5mg / 125.0 mg
Link to NI SPC 12.5mg / 125.0 mg
-
Milbemycin Oxime Praziquantel Chew Alfamed 25.0 mg / 250.0 mg Chewable Tablets for Large Dogs
Active substance: Milbemycin Oxime (A3 and A4), Praziquantel
Territory / Distribution category: NI POM-V
Authorisation holder: Alfamed
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Milpro Chewy 2.5 mg / 25.0 mg Chewable Tablets for Small Dogs and Puppies; Milpro Chewy 12.5 mg / 125.0 mg Chewable Tablets for Dogs; Milpro Chewy 25.0 mg / 250.0 mg Chewable Tablets for Large Dogs
Active substance: Milbemycin Oxime (A3 and A4), Praziquantel
Territory / Distribution category: NI POM-V
Authorisation holder: VIRBAC
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Otomicol Ear Drops and Cutaneous Suspension for Dogs and Cats
Active substance: Miconazole Nitrate, Prednisolone Acetate, Polymyxin B Sulphate
Territory / Distribution category: GB POM-V
Authorisation holder: KRKA, d.d., Novo mesto
Variations - food producing species
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Bovilis INtranasal RSP Live, Nasal Spray, Lyophilisate and Solvent for Suspension for Cattle
Active substance: Bovine parainfluenza virus 3; Bovine respiratory syncytial virus
Territory / Distribution category: NI POM-V
Authorisation holder: MSD Animal Health UK Limited
Summary of change:
Introduction of associated non-mixed use with Bovilis Nasalgen-C.
Introduction of a claim for use of Bovilis INtranasal RSP Live during pregnancy.
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Nobilis MG 6/85 Lyophilisate for Suspension for Chickens
Active substance: Mycoplasma gallisepticum
Territory / Distribution category: GB POM-V
Authorisation holder: MSD Animal Health UK Limited
Summary of change:
Removal of Nobilis MS Live mixed-use claims and related information.
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Norocillin 30% w/v Suspension for Injection [Cattle, Pigs, Sheep]
Active substance: Procaine Benzylpenicillin
Territory / Distribution category: UK POM-V
Authorisation holder: Norbrook Laboratories Limited
Change category: Target species use; Contraindications; Special warnings; Adverse reactions
Summary of change:
Section 4.2: In vitro tests have shown the following organisms to be sensitive: Trueperella pyogenes.
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, 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 recommended dose rate is: 10 mg/kg bodyweight (1 ml/30 kg) daily for 3 to 7 days.
Section 5.1: Enterobacterales, Bacteroides fragilis, most Campylobacter spp., Nocardia spp. and Pseudomonas spp. as well as beta-lactamase–producing Staphylococcus spp. are resistant.
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Porcilis PCV ID Emulsion for Injection for Pigs
Active substance: Porcine circovirus-2
Territory / Distribution category: GB POM-V
Authorisation holder: MSD Animal Health UK Limited
Change category: Target Species use
Summary of change:
Section 4.2: Duration of the immunity extended from 23 weeks to 26 weeks.
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Ultrapen LA 30% Suspension for Injection [Cattle, Pigs]
Active substance: Mycoplasma gallisepticum
Territory / Distribution category: UK POM-V
Authorisation holder: Norbrook Laboratories Limited
Change category: Target Species use, Contradictions; Special warnings; adverse reactions;
Summary of change:
Section 4.2: Ultrapen LA is indicated for use in cattle and pigs in the treatment and control of a wide range of common systemic, respiratory, urinary and local infections caused by or associated with organisms sensitive to penicillin, including Trueperella pyogenes.
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, 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 5.1: Enterobacterales, Bacteroides fragilis, most Campylobacter spp., Nocardia spp. and Pseudomonas spp. as well as beta-lactamase–producing Staphylococcus spp. are resistant.
Variations - companion animal species
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Amcofen 12.5 mg/125.0 mg Chewable Tablets for Dogs Weighing at Least 5 kg; Amcofen 2.5 mg/25 mg Chewable Tablets for Small Dogs and Puppies Weighing at Least 0.5 kg
Active substance: Milbemycin Oxime (A3 and A4); Praziquantel
Territory / Distribution category: GB POM-V
Authorisation holder: KRKA, d.d., Novo mesto
Change category: Adverse reactions
Summary of change:
Section 4.6: On very rare occasions, hypersensitivity reaction, systemic signs (such as lethargy), neurological signs (such as muscle tremors and ataxia) and/or gastrointestinal signs (such as emesis, diarrhoea, anorexia and drooling) have been observed in dogs after administration of the combination of milbemycin oxime and praziquantel.
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MiPet Benazapet 2.5 mg Tablets for Cats and Dogs; MiPet Benazapet 5 mg Tablets for Cats and Dogs; MiPet Benazapet 20 mg Tablets for Dogs
Active substance: Benazepril Hydrochloride
Territory / Distribution category: UK POM-V
Authorisation holder: Elanco Europe Ltd
Change category: Adverse reactions
Summary of change:
Section 4.6: In rare occasions diarrhoea and anorexia have been reported in dogs.
May 2024
Change of distribution category
The following product has a change of distribution category from NFA-VPS to AVM-GSL.
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Krka Wormer 230 mg/20 mg Film-coated Tablets for Cats
Active substance: Praziquantel; Pyrantel Embonate
Territory / Distribution category: GB & NI
Authorisation holder: KRKA, d.d., Novo mesto
Change category: Distribution Category
Summary of change: The distribution category has been changed from NFA-VPS to AVM-GSL.
New Authorisations
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EU Pharma Omeprazole 370 mg/g Oral Paste for Horses
Active substance: Omeprazole
Territory / Distribution category: GB & NI POM-V
Authorisation holder: EU Pharmaceuticals Ltd
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Maycetam 400 mg/ml Solution for Use in Drinking Water for Pigs
Active substance: Paracetamol
Territory / Distribution category: GB POM-V
Authorisation holder: Laboratorios Maymo S.A.
-
Nobilis Multriva RT+IBm+ND+Gm+REOm+EDS Emulsion for Injection for Chickens
Active substance: Avian metapneumovirus, Infectious bronchitis virus, Infectious bronchitis virus, Newcastle disease virus, Infectious bursal disease virus, Infectious bursal disease virus, Avian reovirus, Avian reovirus, Egg drop syndrome virus
Territory / Distribution category: NI POM-V
Authorisation holder: Intervet International BV
SPC available from EU Union Product Database
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Omeprogard 370 mg/g Oral Paste for Horses
Active substance: Omeprazole
Territory / Distribution category: GB & NI POM-V
Authorisation holder: EU Pharmaceuticals Ltd
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Cartaxx 50 mg/ml Solution for Injection for Dogs and Cats
Active substance: Carprofen
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Alfasan Nederland B.V.
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Clavipet 40 mg/10 mg Chewable Tablets for Cats and Dogs; Clavipet 200 mg/50 mg Chewable Tablets for Cats and Dogs
Active substance: Amoxicillin, Clavulanic acid
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Billev Pharma East Ltd
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Clavipet 400 mg/100 mg Chewable Tablets for Dogs
Active substance: Amoxicillin, Clavulanic acid
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Billev Pharma East Ltd
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Cortotic 0.584 mg/ml Ear Spray Solution for Dogs
Active substance: Hydrocortisone aceponate
Territory / Distribution category: GB POM-V
Authorisation holder: VIRBAC
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Dormostart 1 mg/ml Solution for Injection for Dogs and Cats
Active substance: Medetomidine hydrochloride
Territory / Distribution category: NI POM-V
Authorisation holder: Alfasan Nederland B.V.
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Metaxx 0.5 mg/ml Oral Suspension for Cats and Guinea Pigs
Active substance: Meloxicam
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Alfasan Nederland B.V.
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Trilocur 10 mg/ml and 50 mg/ml Oral Suspension for Dogs
Active substance: Trilostane
Territory / Distribution category: NI POM-V
Authorisation holder: Emdoka bvba
SPCs available from EU Union Product Database
-
Trilorale 10 mg/ml Oral suspension for Dogs
Active substance: Trilostane
Territory / Distribution category: NI POM-V
Authorisation holder: Axience
SPC available from EU Union Product Database
Variations - food producing species
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Aivlosin 42.5 mg/g Premix for Medicated Feeding Stuff for Pigs
Active substance: Tylvalosin
Territory / Distribution category: NI POM-V
Authorisation holder: Eco Animal Health Ltd
Change category: Contraindications, Special warnings
Summary of change:
Section 4.7: Use only according to the benefit-risk assessment by the responsible veterinarian.
No signs of adverse effects were observed in sows or their offspring when the veterinary medicinal product 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.
Laboratory studies in animals have not produced any evidence of a teratogenic effect. Maternal toxicity in rodents has been observed at doses of 400 mg tylvalosin per kg bodyweight and above. In mice, a slight reduction in the foetal bodyweight was seen at doses causing maternal toxicity.
SPC available from the EU Union Product Database
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Aivlosin 42.5mg/g Oral Powder for Pigs
Active substance: Tylvalosin
Territory / Distribution category: NI POM-V
Authorisation holder: Eco Animal Health Ltd
Change category: Contraindications, Special warnings
Summary of change:
Section 4.7: Use only according to the benefit-risk assessment by the responsible veterinarian.
No signs of adverse effects were observed in sows or their offspring when the veterinary medicinal product 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.
Laboratory studies in animals have not produced any evidence of a teratogenic effect. Maternal toxicity in rodents has been observed at doses of 400 mg tylvalosin per kg bodyweight and above. In mice, a slight reduction in the foetal bodyweight was seen at doses causing maternal toxicity.
SPC available from the EU Union Product Database
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Aivlosin 625 mg/g Granules for Use in Drinking Water for Pigs
Active substance: Tylvalosin
Territory / Distribution category: NI POM-V
Authorisation holder: Eco Animal Health Ltd
Change category: Contraindications, Special warnings
Summary of change:
Section 4.7: Use only according to the benefit-risk assessment by the responsible veterinarian.
No signs of adverse effects were observed in sows or their offspring when the veterinary medicinal product 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.
Laboratory studies in animals have not produced any evidence of a teratogenic effect. Maternal toxicity in rodents has been observed at doses of 400 mg tylvalosin per kg bodyweight and above. In mice, a slight reduction in the foetal bodyweight was seen at doses causing maternal toxicity.
SPC available from the EU Union Product Database
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CircoMax Emulsion for Injection for Pigs
Active substances: Porcine circovirus-2
Territory / Distribution category: GB POM-V
Authorisation holder: Zoetis UK Limited
Change category: Target species use
Summary of change:
Section 4.9: To add the option to administer CircoMax Myco and Circomax intramuscularly using needle-free devices.
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CircoMax Myco Emulsion for Injection for Pigs
Active substances: Mycoplasma hyopneumoniae; Porcine circovirus-2
Territory / Distribution category: GB POM-V
Authorisation holder: Zoetis UK Limited
Change category: Target species use
Summary of change:
Section 4.9: To add the option to administer CircoMax Myco and Circomax intramuscularly using needle-free devices.
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GUMBOHATCH Lyophilisate and Solvent for Suspension for Injection for Chickens
Active substances: Infectious bursal disease virus
Territory / Distribution category: GB POM-V
Authorisation holder: Laboratorios Hipra SA
Change category: Target species use
Summary of change:
Section 4.1: To include future layer chickens as a sub-category of target species.
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Metaxol 20/100 mg/ml Solution for Use in Drinking Water for Pigs and Chickens
Active substances: Sulfamethoxazole; Trimethoprim
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Eurovet Animal Health B.V.
Change category: Contraindications, Special warnings
Summary of change:
Section 3.5: 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 should be worn when handling the veterinary medicinal product by women of childbearing age.
Section 3.7: The safety of the veterinary medicinal product has not been established in pigs and chickens during pregnancy, lactation, lay 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.
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Omeproshield 370 mg/g Oral Paste for Horses
Active substances: Omeprazole
Territory / Distribution category: NI POM-V
Authorisation holder: Boehringer Ingelheim Animal Health UK Ltd
Change category: Target species use
Summary of change:
Section 3.2: The indication for the treatment of gastric ulcers has been deleted, so that the product is now only indicated for the prevention of gastric ulcers.
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Diatrim 200 mg/ml + 40 mg/ml solution for injection for cattle, pigs, dogs and cats
Active substances: Sulfadiazine; Trimethoprim
Territory / Distribution category: NI POM-V
Authorisation holder: Eurovet Animal Health B.V.
Change category: Contraindications, Special warnings
Summary of change:
Section 3.5: Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Women of childbearing age, pregnant women or women suspected of being pregnant should use the veterinary medicinal product with serious caution to avoid accidental self-injection.
Section 3.7: The safety of the veterinary medicinal product has not been established in cattle, pigs, dogs and 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.
Variations - companion animal species
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BenazeVet 2.5 / 5 mg Tablets for Cats and Dogs
Active substances: Benazepril Hydrochloride
Territory / Distribution category: UK POM-V
Authorisation holder: Elanco Europe Ltd
Change category: Adverse reactions
Summary of change:
Section 4.6: Diarrhoea and anorexia have been reported in dogs on rare occasions (more than 1 but less than 10 animals in 10,000 animals treated).
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BenazeVet 20 mg Tablets for Dogs
Active substances: Benazepril Hydrochloride
Territory / Distribution category: UK POM-V
Authorisation holder: Elanco Europe Ltd
Change category: Adverse events
Summary of change:
Section 4.6: Diarrhoea and anorexia have been reported in dogs on rare occasions (more than 1 but less than 10 animals in 10,000 animals treated).
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Credelio chewable tablets for dogs [Range]
Active substances: Lotilaner
Territory / Distribution category: NI POM-V
Authorisation holder: Elanco GmbH
Change category: Adverse events
Summary of change:
Section 4.6: Very rare (<1 animal/10,000 animals treated, including isolated reports) frequency:
Mild and transient: Bloody diarrhoea, polydipsia, pruritus, innappropriate urination, polyuria, urinary incontinence.
Typically resolves without treatment: polydipsia, pruritus, polyuria, urinary incontinence.
SPCs available from EU Union Product Database
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Eurican DAP Lyophilisate and Solvent for Suspension for Injection; Eurican DAPPi Lyophilisate and Solvent for Suspension for Injection
Active substances: Canine adenovirus; Canine distemper virus; Canine parvovirus
Territory / Distribution category: NI POM-V
Authorisation holder: Boehringer Ingelheim Animal Health UK Ltd
Change category: Interactions and Overdose
Summary of change:
Section 3.8: To add a new claim for compatibility with the new Boehringer Ingelheim's Eurican L4 vaccine.
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Fortekor 2.5 mg Tablets for Cats and Dogs
Active substances: Benazepril Hydrochloride
Territory / Distribution category: GB POM-V
Authorisation holder: Elanco Europe Ltd
Change category: Adverse reactions
Summary of change:
Section 4.6: Diarrhoea and anorexia have been reported in dogs on rare occasions (more than 1 but less than 10 animals in 10,000 animals treated).
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Fortekor Flavour 5 mg Tablets for Cats and Dogs
Active substances: Benazepril Hydrochloride
Territory / Distribution category: GB POM-V
Authorisation holder: Elanco Europe Ltd
Change category: Adverse reactions
Summary of change:
Section 4.6: Diarrhoea and anorexia have been reported in dogs on rare occasions (more than 1 but less than 10 animals in 10,000 animals treated).
-
Fortekor Flavour 20 mg Tablets for Dogs
Active substances: Benazepril Hydrochloride
Territory / Distribution category: GB POM-V
Authorisation holder: Elanco Europe Ltd
Change category: Adverse reactions
Summary of change:
Section 4.6: Diarrhoea and anorexia have been reported in dogs on rare occasions (more than 1 but less than 10 animals in 10,000 animals treated).
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Johnson’s Guardian Plus Spot-On Solution for Cats & Ferrets
Active substances: (S)-Methoprene; Fipronil
Territory / Distribution category: UK AVM-GSL
Authorisation holder: EU Pharmaceuticals Ltd
Change category: Target species use
Summary of change:
Section 4.1: Removal of ferrets as a target species and corresponding change of name to Johnson’s Guardian Plus Spot-On Solution for Cats.
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Aderexa 2.5 mg/25 mg Chewable Tablets for Small Dogs and Puppies weighing at least 0.5 kg; Aderexa 12.5 mg/125 mg Chewable Tablets for Dogs weighing at least 5 kg
Active substances: Milbemycin Oxime (A3 and A4); Praziquantel
Territory / Distribution category: GB & NI POM-V
Authorisation holder: KRKA, d.d., Novo mesto
Change category: Adverse reactions
Summary of change:
Section 4.6: Hypersensitivity reactions have been added to as a very rare (less than 1 animal in 10,000 animals treated, including isolated reports) adverse event.
Link to Aderexa 2.5mg/25mg GB SPC
Link to Aderexa 2.5mg/25mg NI SPC
Link to Aderexa 12.5 mg/125 mg GB SPC
Link to Aderexa 12.5 mg/125 mg GB SPC
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Mektix 2.5 mg/25 mg Chewable Tablets for Small Dogs and Puppies Weighing at Least 0.5 kg; Mektix 12.5 mg/125 mg Chewable Tablets for Dogs Weighing at Least 5 kg
Active substances: Milbemycin Oxime (A3 and A4); Praziquantel
Territory / Distribution category: GB & NI POM-V
Authorisation holder: KRKA, d.d., Novo mesto
Change category: Adverse reactions
Summary of change:
Section 4.6: Hypersensitivity reactions have been added to as a very rare (less than 1 animal in 10,000 animals treated, including isolated reports) adverse event.
Link to Mektix 2.5mg/25mg GB SPC
Link to Mektix 2.5mg/25mg NI SPC
Link to Mektix 12.5 mg/125 mg GB SPC
Link to Mektix 12.5 mg/125 mg NI SPC
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Loxicom 0.5 mg/ml Oral Suspension for Cats
Active substances: Meloxicam
Territory / Distribution category: NI POM-V
Authorisation holder: Norbrook Laboratories Ltd
Change category: Contraindications, Special warnings
Summary of change:
Section 4.5: This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.
SPC available from EU Union Product Database
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Loxicom 0.5 / 1.5 mg/ml Oral Suspension for Dogs
Active substances: Meloxicam
Territory / Distribution category: NI POM-V
Authorisation holder: Norbrook Laboratories Ltd
Change category: Contraindications, Special warnings
Summary of change:
Section 4.5: This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.
Loxicom 1.5 mg/ml Oral Suspension for Dogs: This product for dogs should not be used in cats as it is not suitable for use in this species. In cats, Loxicom 0.5 mg/ml oral suspension for cats should be used.
SPCs available from EU Union Product Database
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Loxicom 5 mg/ml Solution for Injection for Dogs and Cats
Active substances: Meloxicam
Territory / Distribution category: NI POM-V
Authorisation holder: Norbrook Laboratories Ltd
Change category: Contraindications, Special warnings
Summary of change:
Section 4.5: This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.
SPCs available from EU Union Product Database
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NexGard Combo Spot-on Solution for Cats <2.5 kg; NexGard Combo Spot-on Solution for Cats 2.5-7.5 kg
Active substances: Eprinomectin; Esafoxolaner; Praziquantel
Territory / Distribution category: NI POM-V
Authorisation holder: Boehringer Ingelheim Vetmedica GmbH
Change category: Target species use; Contraindications, Special warnings
Summary of change:
Section 4.2: Persistent tick killing activity from 7 days to five weeks after treatment against Rhipicephalus sanguineus and Persistent tick killing activity from 7 days to four weeks after treatment against Ixodes hexagonus.
Section 4.5 i): Target animal safety has not been evaluated beyond 6 consecutive monthly treatments and accumulation of esafoxolaner and eprinomectin was observed up to the 5th monthly administration (see also sections 4.10 and 5.2). Repeated treatments beyond 6 consecutive months should be restricted to limited individual situations (see section 4.9 for treatment guidance), with a minimum treatment interval of 4 weeks, according to a benefit-risk evaluation by the responsible veterinarian.
NI SPC <2.5 kg available from EU Union Product Database
NI SPC 2.5-7.5 kg available from EU Union Product Database
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Nexgard Spectra Chewable Tablets for Dogs [Range]
Active substances: Afoxolaner; Milbemycin Oxime (A3 and A4)
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Boehringer Ingelheim Vetmedica GmbH
Change category: Target species use
Summary of change:
Section 4.9: Lowering of the minimum bodyweight from 2.0 -3.5kg to 1.35 - 3.5kg.
NI SPCs available from EU Union Product Database
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Propalin Syrup 40 mg/ml Dogs
Active substances: Phenylpropanolamine
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Vetoquinol UK Ltd
Change category: Contraindications, Special warnings
Summary of change:
Section 4.5: Due to the very low doses to be administered, and to avoid any risk of overdose, the animal must be weighed, and the recommended doses must be respected.
Section 4.6: Sympathomimetics may produce very rarely a wide range of effects, most of which mimic the results of excessive stimulation of the sympathetic nervous system such as effects on heart rate (tachycardia) or effects on blood pressure (increased blood pressure), which can induce proteinuria.
Dizziness, decrease in appetite, arrhythmia, collapse, aggression, hyperactivity (including restlessness), polydipsia, polyuria, ataxia, seizure and hypersensitivity may occur in very rare cases.
Liquid diarrhoea/loose stool, emesis and lethargy have been reported rarely.
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Solensia 7 mg/ml Solution for Injection for Cats
Active substances: Frunevetmab
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Zoetis UK Limited
Change category: Adverse reactions
Summary of change:
Section 4.6: To include skin disorders such as skin scab and skin sore as rare adverse events (1 to 10 animals/10,000 animals treated).
NI SPC available on the EU Union Product Database
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Stomorgyl 2 /10 / 20 Film-coated Tablets [Cats, Dogs]
Active substances: Metronidazole; Spiramycin
Territory / Distribution category: UK POM-V
Authorisation holder: Boehringer Ingelheim Animal Health UK Ltd
Change category: Adverse events
Summary of change:
Section 4.6: Digestive tract disorders (vomitus, diarrhoea, anorexia) may occur very rarely.