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.
February 2024
Change of distribution category
The following product has a change of distribution category from POM-V to AVM-GSL.
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Krka Combo 50 mg/60 mg Spot-on Solution for Cats
Active substance: (S)-Methoprene
Fipronil
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 POM-V to AVM-GSL.
The following product has a change of distribution category from NFA-VPS to AVM-GSL.
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Krka Roundworm and Tapeworm Wormer 50/144/150 mg Tablets for Dogs
Active substance: Febantel, Praziquantel and 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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Arthrocam 0.5 mg/ml Oral Suspension for Cats
Active substance: Meloxicam
Territory / Distribution category: GB & NI POM-V
Authorisation holder: EU Pharmaceuticals Ltd
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Arthrocam 1.5 mg/ml Oral Suspension for Dogs
Active substance: Meloxicam
Territory / Distribution category: GB & NI POM-V
Authorisation holder: EU Pharmaceuticals Ltd
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Dormostart 1 mg/ml Solution for Injection for Dogs and Cats
Active substance: Medetomidine Hydrochloride
Territory / Distribution category: GB POM-V
Authorisation holder: Alfasan Nederland B.V.
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Felimazole 5 mg/ml Oral Solution for Cats
Active substance: Thiamazole
Territory / Distribution category: GB POM-V
Authorisation holder: Dechra Limited
Variations - food producing species
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Circovac Emulsion and Suspension for Emulsion for Injection for Pigs
Active substance: Porcine circovirus-2
Territory / Distribution category: NI POM-V
Authorisation holder: Ceva-Phylaxia Veterinary Biologicals Co. Ltd
Change category: Target Species use; Interactions and Overdose
Summary of change:
Section 4.2: Duration of immunity (DOI) amended to 23 weeks.
Section 4.8: Duration of lethargy amended to 1-2 days and to include warning when Circovac is used mixed with Hyogen.
Link to SPC to follow
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Suiseng Coli / C Suspension for Injection for Pigs
Active substances: Clostridium novyi, Clostridium perfringens, Escherichia coli
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Laboratorios Hipra SA
Change category: Target species use; Interactions and overdose
Summary of change:
Sections 4.8, 4.9 and 6.5: Amended to include the associated use of the vaccine Suiseng Diff/A with the vaccine Suiseng Coli/C.
Variations - companion animal species
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Advantix Spot-on Solution for Dogs [Range over 10kg up to 60kg]
Active substances: Imidacloprid; Permethrin (Cis:Trans 40:60)
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Elanco Europe Ltd
Change category: Contraindications; Special warnings
Summary of change:
Section 4.5: Laboratory studies in rabbits and rats with the excipient N-Methylpyrrolidone 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.
Link to GB SPC over 10kg up to 25kg
Link to NI SPC over 10kg up to 25kg
Link to GB SPC over 25kg up to 40kg
Link to NI SPC over 25kg up to 40kg
Link to GB SPC over 40kg up to 60kg
Link to NI SPC over 40kg up to 60kg
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Versican Plus Bb Oral Lyophilisate and Solvent for Oral Suspension for Dogs
Active substances: Bordetella bronchiseptica
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Zoetis UK Limited
Change category: Target species use
Summary of change:
Section 4.2: Amendment of the onset of immunity (OOI) to 7 days.
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Metacam 5 mg/ml Solution for Injection for Dogs and Cats; Metacam 0.5 mg/ml Oral Suspension for Cats and Guinea Pigs; Metacam 2mg/ml Solution for Injection for Cats
Active substances: Meloxicam
Territory / Distribution category: NI POM-V
Authorisation holder: Boehringer Ingelheim Vetmedica Gmbh
Change category: Target species use
Summary of change:
Section 4.2: Indication for cats; Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in cats, e.g. orthopaedic and soft tissue surgery.
January 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 Roundworm and Tapeworm Wormer 230 mg/20 mg Film-coated Tablets for Cats
Active substances: Praziquantel, Pyrantel Embonate
Territory / Distribution category: GB & NI AVM-GSL
Authorisation holder: MSD Animal Health UK Limited
Change category:
Summary of change:
The distribution category has changed from NFA-VPS to AVM-GSL.
New Authorisations
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PREVEXXION RN+HVT Concentrate and Solvent for Suspension for Injection [Chickens]
Active substance: Marek's disease virus
Territory / Distribution category: NI POM-V
Authorisation holder: Boehringer Ingelheim Vetmedica GmbH
Link to SPC to follow
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Pyrocam 15 mg/ml Oral Suspension for Pigs
Active substance: Meloxicam
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Huvepharma N.V.
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CaniTrio Chewable Tablets for Dogs [Range from 1.25-60 kg]
Active substance: Pyrantel, Sarolaner, Moxidectin
Territory / Distribution category: GB POM-V
Authorisation holder: Zoetis UK Limited
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Dexdormostart 0.5 mg/ml Solution for Injection for Dogs and Cats
Active substance: Dexmedetomidine hydrochloride
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Alfasan Nederland B.V.
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Ridamax 40 mg + 4 mg Spot-on Solution for Small Cats and Ferrets
Active substance: Imidacloprid, Moxidectin
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd
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Ridamax 80 mg + 8 mg Spot-on Solution for Large Cats
Active substance: Imidacloprid, Moxidectin
Territory / Distribution category: GB & NI POM-V
Authorisation holder:Chanelle Pharmaceuticals Manufacturing Ltd
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Thiamapet 10 mg/ml Oral Solution for Cats
Active substance: Thiamazole
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Ecuphar NV
Variations - food producing species
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Animec 10 mg/ml Solution for Injection for Cattle, Pigs and Sheep
Active substance: Ivermectin
Territory / Distribution category: GB POM-VPS
Authorisation holder: Chanelle Animal Health Ltd
Change category: Target species use
Summary of change:
Section 4.2: Sheep added as a new target species for the indication of treatment of infections with a number of specific gastrointestinal roundworms, lungworms, nasal bots (Oestrus ovis) and mange mites (Psoroptes ovis). Multiple associated changes have been made to sections of the SPC.
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Circovac Emulsion and Suspension for Emulsion for Injection for Pigs
Active substance: Porcine circovirus-2
Territory / Distribution category: GB POM-V
Authorisation holder: Ceva Animal Health Ltd
Change category: Interactions and Overdose
Summary of change:
Section 4.8. Harmonisation of the duration of immunity for Circovac between its single use and associate mixed use with Hyogen to 23 weeks.
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Florinject 300 mg/ml Solution for Injection for Cattle and Pigs
Active substance: Florfenicol
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Laboratorios Calier, S.A.
Change category: Contraindications, Special warnings
Summary of change:
Section 3.5 (NI) / 4.5 (GB): 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 (NI) / 4.7 (GB): 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.
Section 5.5 (NI) / 6.6 (GB): The veterinary medicinal product should not enter water courses as florfenicol may be dangerous for fish and other aquatic organisms.
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Gallifen 200 mg/ml Suspension for Use in Drinking Water for Chickens and Pheasants
Active substance: Fenbendazole
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Huvepharma N.V.
Change category: Target species use
Summary of change:
Section 4.2 ( GB) 3.2 (NI): Added the treatment of chickens infected with adult stages of Raillietina echinobothrida. Multiple associated changes have been made to sections of the SPC.
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Nifencol 300 mg/ml Solution for Injection for Cattle and Pigs
Active substance: Florfenicol
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Vetpharma Animal Health, S.L
Change category: Contraindications, Special warnings
Summary of change:
Section 4.5: Updated to reflect that 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 products with serious caution to avoid accidental self-injection.
Section 4.7: Updated to reflect that the safety of the veterinary medicinal products has not been established in the target species 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.
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Tetroxy L.A. 200 mg/ml Oxytetracycline Solution for Injection [Cattle, Pigs, Sheep]
Active substance: Oxytetracycline
Territory / Distribution category: UK POM-V
Authorisation holder: Bimeda Animal Health Limited
Change category: Contraindications, Special warnings
Summary of change:
Section 4.5: Updated to reflect that 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 products with serious caution to avoid accidental self-injection.
Section 4.7: Updated to reflect that the safety of the veterinary medicinal products has not been established in the target species 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.
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Nobilis IB 4-91 Lyophilisate for Oculonasal Suspension/use in Drinking Water for Chickens
Active substance: Infectious bronchitis virus
Territory / Distribution category: GB POM-V
Authorisation holder: MSD Animal Health UK Limited
Change category: Target species use
Summary of change:
Section 4.2: To include the onset and duration of immunity. Onset of immunity: 3 weeks and Duration of immunity: at least 6 weeks.
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Zermex 0.1% w/v Oral Solution for Sheep
Active substance: Moxidectin
Territory / Distribution category: UK POM-VPS
Authorisation holder: Zoetis UK Limited
Change category:
Summary of change:
Additional statements were added throughout the SPC in relation to the development of resistance.
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ZORABEL 25 mg/ml Solution for Use in Drinking Water for Chickens and Turkeys
Active substance: Toltrazuril
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Vetpharma Animal Health, S.L
Change category: Withdrawal period
Summary of change:
Section 4.11: Updated to reflect that the veterinary medicinal product must not be used within 6 weeks before the start of the laying period.
Variations - companion animal species
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Canigen DP Lyophilisate and Solvent for Suspension for Injection for Dogs (Puppies)
Active substances: Canine distemper virus;
Canine parvovirus
Territory / Distribution category: GB POM-V
Authorisation holder: MSD Animal Health UK Limited
Change category: Contraindications, Special warnings; Adverse reactions
Summary of change:
Section 4.5 and 4.6: Added lethargy (rare) and hypersensitivity (very rare).
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Quantilex Plus Tablets for Dogs
Active substances: Febantel, Praziquantel, Pyrantel
Territory / Distribution category: UK NFA-VPS
Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd
Change category: Adverse reactions
Summary of change:
Section 4.6: In very rare cases slight and transient digestive tract disorders such as vomiting and/or diarrhoea may occur. In individual cases these signs can be accompanied by nonspecific signs such as lethargy, anorexia or hyperactivity.
December 2023
New Authorisations
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Nobivac LoVo L4 Suspension for Injection for Dogs
Active substance: Leptospira interrogans serogroup Canicola, Leptospira interrogans serogroup Icterohaemorrhagiae, Leptospira interrogans serogroup Australis, Leptospira kirschneri serogroup Grippotyphosa
Territory / Distribution category: NI POM-V
Authorisation holder: Intervet International BV
Link to SPC to follow
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Senvelgo 15 mg/ml Oral Solution for Cats
Active substance: Velagliflozin
Territory / Distribution category: NI POM-V
Authorisation holder: Boehringer Ingelheim Vetmedica GmbH
Link to SPC to follow
Variations - food producing species
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Cydectin 0.1% w/v Oral Solution for Sheep
Active substance: Moxidectin
Territory / Distribution category: GB & NI POM-VPS
Authorisation holder: Zoetis UK Limited
Change category: Contraindications, Special warnings; Target species use
Summary of change:
Section 4.4: Updated to reflect current antimicrobial resistance data.
Section 4.9: Underdosing could result in ineffective use and may favour resistance development. 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.
Section 5.1: Resistance to moxidectin is mediated in part by membrane transporter P-glycoproteins, and cross resistance with other macrocyclic lactones is possible.
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Equest Pramox 19.5 mg/g + 121.7 mg/g Oral Gel [Horses]
Active substance: Moxidectin
Praziquantel
Territory / Distribution category: GB & NI POM-VPS
Authorisation holder: Zoetis UK Limited
Change category: Adverse reactions
Summary of change:
Section 4.6: Digestive discomfort (colic, loose stool) has been observed in very rare cases based on post-marketing surveillance data.
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Equilis Prequenza, Suspension for Injection, for Horses
Active substance: Equine influenza virus
Territory / Distribution category: GB POM-V
Authorisation holder: MSD Animal Health UK Limited
Change category: Adverse reactions
Summary of change:
Section 4.6: Added Hypersensitivity reaction.
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Methoxasol 20/100 mg/ml Solution for Use in Drinking Water for Pigs and Chickens
Active substance: 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 4.5: Laboratory studies in rabbits and rats conducted 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 4.7: 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.
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Noroseal 2.6g Intramammary Suspension for Cattle
Active substance: Bismuth Subnitrate
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Norbrook Laboratories Limited
Change category: Adverse reactions; Contraindications, Special warnings; Target species use.
Summary of change:
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.
Refer to sections 4.5 and 4.9 regarding the importance of aseptic technique.
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Subestin 25 microgram/ml Oral Solution for Horses
Active substance: Clenbuterol Hydrochloride
Territory / Distribution category: GB POM-V
Authorisation holder: Floris Animal Health Limited
Change category: Adverse reactions; Contraindications, Special warnings
Summary of change:
Section 4.6: Updated to include lethargy as an adverse event of rare frequency.
Section 4.7: If used during pregnancy, treatment must be discontinued a minimum of 4 days before the expected time of delivery or at signs of approaching parturition, since uterine contractions may be abolished or labour may be prolonged.
Variations - companion animal species
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Canixin DHPPi Lyophilisate and Solvent for Suspension for Injection for Dogs
Active substances: Canine adenovirus; Canine distemper virus; Canine parainfluenza virus; Canine parvovirus
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Virbac
Change category: Interactions
Summary of change:
Section 4.8: Vaccine can be mixed and administered with Virbac’s Leptospira vaccine containing the serovars Leptospira interrogans (serogroup Canicola serovar Canicola and serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae) or Virbac’s rabies vaccine, if available.
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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:
GB Section 4.6: Added anaphylaxis with frequency very rare
NI SPC: Adverse Reactions: skin disorders (e.g. skin scab, skin sore) now categorised as rare.
Link to NI SPC to follow
November 2023
New Authorisations
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Bovilis Cryptium Emulsion for Injection for Cattle
Active substance: Cryptosporidium parvum
Territory / Distribution category: NI POM-V
Authorisation holder: Intervet International BV
Link to SPC to follow
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Primun Salmonella T Lyophilisate for Use in Drinking Water for Chickens
Active substance: Salmonella typhimurium
Territory / Distribution category: GB POM-V
Authorisation holder: Laboratorios Calier, SA
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Loxitab 1 mg / 2.5 mg Tablets for Dogs
Active substance: Meloxicam
Territory / Distribution category: NI POM-V
Authorisation holder: Zoetis UK Limited
Link to SPC 1mg to follow
Link to SPC 2.5mg to follow
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Meloxoral 1.0 / 2.5 mg / 4.0 Chewable Tablets for Dogs
Active substance: Meloxicam
Territory / Distribution category: NI POM-V
Authorisation holder: Dechra Regulatory B.V.
Link to 1.0mg SPC to follow
Link to 2.5mg SPC to follow
Link to 4.0mg SPC to follow
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Milbeguard Duo 2.5 mg / 25 mg Chewable Tablets for Small Dogs and Puppies
Active substance: Milbemycin Oxime (A3 and A4), Praziquantel
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Ceva Animal Health Ltd
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Milbeguard Duo 12.5 mg / 125 mg Chewable Tablets for Dogs
Active substance: Milbemycin Oxime (A3 and A4), Praziquantel
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Ceva Animal Health Ltd
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Milbeguard Duo 25 mg / 250 mg Chewable Tablets for Large Dogs
Active substance: Milbemycin Oxime (A3 and A4), Praziquantel
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Ceva Animal Health Ltd
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Milbeguard Duo 4 mg / 10 mg Film Coated Tablets for Small Cats and Kittens
Active substance: Milbemycin Oxime (A3 and A4), Praziquantel
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Ceva Animal Health Ltd
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Oxmax (previously OC99) 65 mg/ml Solution for Infusion for Dogs
Active substance: Hemoglobin betafumaril (bovine)
Territory / Distribution category: GB & NI POM-V
Authorisation holder: New Alpha Innovation Biopharmaceutical Ireland Limited
Link to NI SPC to follow
Variations - food producing species
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AMX 10 mg/ml Concentrate for Solution for Fish Treatment [Atlantic salmon, Trout]
Active substance: Deltamethrin 10 mg/ml
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Pharmaq AS
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 should be worn when handling the veterinary medicinal product by women of childbearing age.
Section 4.7: The safety of the veterinary medicinal product has not been established in Atlantic salmon and rainbow trout 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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Animec 10 mg/ml Solution for Injection for Cattle, Pigs and Sheep
Active substance: Ivermectin 10 mg
Territory / Distribution category: NI POM-VPS
Authorisation holder: Chanelle Animal Health Ltd
Change category: Target Species Use
Summary of change:
Section 4.1, 4.2 and various: Addition of sheep as a target species. Treatment of infections with a number of specific gastrointestinal roundworms, lungworms, nasal bots (Oestrus ovis) and mange mites (Psoroptes ovis) in sheep.
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CircoMax Emulsion for Injection for Pigs and CircoMax Myco Emulsion for Injection for Pigs
Active substance: Porcine circovirus-2
Territory / Distribution category: NI POM-V
Authorisation holder: Zoetis Belgium
Change category: Target Species Use
Summary of change:
Section 4.9: Added option of administering CircoMax and CircoMax Myco intramuscularly, using needle-free devices.
Link to SPC to follow
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Eprecis 20 mg/ml Solution for Injection for Cattle, Sheep and Goats
Active substance: Eprinomectin
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Ceva Animal Health Ltd
Change category: Target Species Use
Summary of change:
Section 4.2: Indicated for the treatment of infestations of nasal bots (Oestrus ovis) in sheep and goats.
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Equilis Te, Suspension for Injection, for Horses
Active substance: Clostridium tetani
Territory / Distribution category: GB POM-V
Authorisation holder: MSD Animal Health UK Limited
Change category: Adverse reactions
Summary of change:
Section 4.6: Addition of the adverse event hypersensitivity reaction with a very rare frequency
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Porcilis PCV ID Emulsion for Injection for Pigs
Active substance: Porcine circovirus-2
Territory / Distribution category: NI POM-V
Authorisation holder: Intervet International BV
Change category: Target Species Use
Summary of change:
Section 4.2: Duration of immunity 26 weeks.
Link to NI SPC to follow
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Proteq West Nile Suspension for Injection for Horses
Active substance: West Nile virus
Territory / Distribution category: GB POM-V
Authorisation holder: Boehringer Ingelheim Vetmedica Gmbh
Change category: Adverse reastions; Target Species Use
Summary of change:
Section 4.6: Addition of injection site abscess with a very rare frequency.
Section 4.9: For the administration of the vaccine, use sterile and antiseptic-free and/or disinfectant-free material.
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Rispoval IBR-Marker Live [Cattle]
Active substance: Infectious bovine rhinotraceitis virus
Territory / Distribution category: NI POM-V
Authorisation holder: Zoetis UK Limited
Change category: Target Use Species
Summary of change:
Section 3.9: Added the intranasal vaccination route to cattle of 3 months of age and above.
Variations - companion animal species
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Ataxxa 200 mg/40 mg Spot-on Solution for Dogs up to 4 kg
Active substances: Imidacloprid, Permethrin (Cis:Trans 40:60)
Territory / Distribution category: GB POM-V
Authorisation holder: KRKA, d.d., Novo mesto
Change category: Contraindications, Special warnings
Summary of change:
Section 4.7: The safety of the veterinary medicinal product has not been established in dogs 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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Ataxxa 500 mg/100 mg Spot-on Solution for Dogs Over 4 kg up to 10 kg
Active substances: Imidacloprid, Permethrin (Cis:Trans 40:60)
Territory / Distribution category: GB POM-V
Authorisation holder: KRKA, d.d., Novo mesto
Change category: Contraindications, Special warnings
Summary of change:
Section 4.7: The safety of the veterinary medicinal product has not been established in dogs 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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Ataxxa 1250 mg/250 mg Spot-on Solution for Dogs over 10 kg up to 25 kg
Active substances: Imidacloprid, Permethrin (Cis:Trans 40:60)
Territory / Distribution category: GB POM-V
Authorisation holder: KRKA, d.d., Novo mesto
Change category: Contraindications, Special warnings
Summary of change:
Section 4.7: The safety of the veterinary medicinal product has not been established in dogs 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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Ataxxa 2000 mg/400 mg Spot-on Solution for Dogs Over 25 kg
Active substances: Imidacloprid, Permethrin (Cis:Trans 40:60)
Territory / Distribution category: GB POM-V
Authorisation holder: KRKA, d.d., Novo mesto
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 should be worn when handling the veterinary medicinal product by women of childbearing age.
Section 4.7: The safety of the veterinary medicinal product has not been established in dogs 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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Prevomax 10 mg/ml Solution for Injection for Dogs and Cats
Active substance: Maropitant
Territory / Distribution category: GB POM-V
Authorisation holder: Dechra Regulatory B.V.
Change category: Adverse reactions
Summary of change:
Section 4.6: Added lethargy, ataxia, convulsion, seizures, and muscle tremors as very rare adverse events.
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Strantel 230/20 mg Flavoured Film-coated Tablets for Cats
Active substance: Praziquantel
Pyrantel Embonate
Territory / Distribution category: GB & NI NFA-VPS
Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd
Change category: Adverse reactions
Summary of change:
Section 4.6: Added hypersalivation as a very rare adverse event.
October 2023
New Authorisations
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Hydrotrim 500 mg/g + 100 mg/g Powder for Use in Drinking Water/Milk for Cattle, Sheep, Pigs and Chickens
Active substance: Trimethoprim, Sulfadiazine Sodium
Territory / Distribution category: NI POM-V
Authorisation holder: Huvepharma NV
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Luteoplan 0.25 mg/ml Solution for Injection for Cattle and Horses
Active substance: Cloprostenol
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Syn Vet-Pharma Ireland Limited
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Protivity Lyophilisate and Solvent for Suspension for Injection for Cattle
Active substance: Mycoplasma bovis
Territory / Distribution category: NI POM-V
Authorisation holder: Zoetis UK Limited
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Arocenia 10 mg/ml Solution for Injection for Dogs and Cats
Active substance: Maropitant
Territory / Distribution category: GB & NI POM-V
Authorisation holder: KRKA, d.d., Novo mesto
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Felimazole 5 mg/ml Oral Solution for Cats
Active substance: Thiamazole
Territory / Distribution category: NI POM-V
Authorisation holder: Dechra Limited
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Lotilaner Elanco 12 mg Chewable Tablets for Cats (0.5–2.0 kg)
Active substance: Lotilaner
Territory / Distribution category: GB POM-V
Authorisation holder: Elanco GmbH
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Lotilaner Elanco 48 mg Chewable Tablets for Cats (>2.0–8.0 kg)
Active substance: Lotilaner
Territory / Distribution category: GB POM-V
Authorisation holder: Elanco GmbH
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Lotilaner Elanco 56 mg Chewable Tablets for Dogs (1.3–2.5 kg)
Active substance: Lotilaner
Territory / Distribution category: GB POM-V
Authorisation holder: Elanco GmbH
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Lotilaner Elanco 112 mg Chewable Tablets for Dogs (>2.5–5.5 kg)
Active substance: Lotilaner
Territory / Distribution category: GB POM-V
Authorisation holder: Elanco GmbH
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Lotilaner Elanco 225 mg Chewable Tablets for Dogs (>5.5–11 kg)
Active substance: Lotilaner
Territory / Distribution category: GB POM-V
Authorisation holder: Elanco GmbH
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Lotilaner Elanco 450 mg Chewable Tablets for Dogs (>11–22 kg)
Active substance: Lotilaner
Territory / Distribution category: GB POM-V
Authorisation holder: Elanco GmbH
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Lotilaner Elanco 900 mg Chewable Tablets for Dogs (>22–45 kg)
Active substance: Lotilaner
Territory / Distribution category: GB POM-V
Authorisation holder: Elanco GmbH
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Milbeguard Duo 16mg / 40mg Film-coated Tablet for Cats
Active substance: Milbemycin Oxime (A3 and A4), Praziquantel
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Ceva Animal Health Ltd
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Movocam 0.5 mg/ml Oral Suspension for Cats
Active substance: Meloxicam
Territory / Distribution category: GB & NI POM-V
Authorisation holder: EU Pharmaceuticals Ltd
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Movocam 1.5 mg/ml Oral Suspension for Dogs
Active substance: Meloxicam
Territory / Distribution category: GB & NI POM-V
Authorisation holder: EU Pharmaceuticals Ltd
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Trilotab 10 mg / 30 mg / 60 mg / 120 mg / 150 mg Chewable Tablets for Dogs
Active substance: Trilostane
Territory / Distribution category: NI POM-V
Authorisation holder: CP Pharma Handelsgesellschaft mbH
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Uriphex, Oral Solution for Dogs
Active substance: Phenylpropanolamine Hydrochloride
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Alfasan Nederland B.V.
Variations - food producing species
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Resflor 300/16.5 mg/ml Solution for Injection for Cattle
Active substance: Florfenicol, Flunixin
Territory / Distribution category: GB & NI
Authorisation holder: MSD Animal Health UK Limited
Change category: Contraindications, Special warnings
Summary of change:
Section 4.5i GB SPC/3.5i NI SPC: 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.
People with known hypersensitivity to propylene glycol and polyethylene glycols should avoid contact with the veterinary medicinal product.
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 GB SPC/3.7 NI SPC: The safety of the veterinary medicinal product has not been established in cattle 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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Selectan 300 mg/ml Solution for Injection for Cattle and Swine
Active substance: Florfenicol
Territory / Distribution category: UK POM-V
Authorisation holder: Laboratorios Hipra SA
Change category: Contraindications, Special warnings
Summary of change:
Section 4.5ii: 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: The safety of the veterinary medicinal product has not been established in cattle and swine 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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Florfenikel 300 mg/ml Solution for Injection for Cattle and Pigs
Active substance: Florfenicol
Territory / Distribution category: UK POM-V
Authorisation holder: Kela NV
Change category: Contraindications, Special warnings
Summary of change:
Section 4.5ii: 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: The safety of the veterinary medicinal product has not been established in cattle and pigs during pregnancy and 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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Animeloxan 5 mg/ml Solution for Injection for Dogs and Cats
Active substances: Meloxicam
Territory / Distribution category: UK POM-V
Authorisation holder: AniMedica GmbH
Change category: Contraindications, Special warnings
Summary of change:
Section 4.5ii: NSAIDs and other prostaglandin inhibitors are known to have adverse effects on pregnancy and/or embryofoetal development. 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: Do not use in pregnant or lactating animals. The safety of the veterinary medicinal product has not been established in 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.
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Marbocyl SA 200 mg Powder and Solvent for Solution for Injection [Cats, Dogs]
Active substances: Marbofloxacin
Territory / Distribution category: UK POM-V
Authorisation holder: Vetoquinol UK Ltd
Change category: Contraindications, Special warnings
Summary of change:
Section 4.3: Do not use in cases of resistance to other fluoroquinolones (cross-resistance).’ And ‘Do not use in cases of hypersensitivity to the active substance, to any other quinolones or to any of the excipients.
Section 4.5i: Fluoroquinolones have been shown to induce erosion of articular cartilage in juvenile dogs and care should be taken to dose accurately especially in young animals.
Fluoroquinolones are also known for their potential neurological side effects. Cautious use is recommended in dogs and cats diagnosed as suffering from epilepsy.
Additional precautions have been added relating to prudent use of fluoroquinolones.
Section 4.6: Very rarely, hypersensitivity reactions, diarrhoea and vomiting have been reported. 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).
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Nexgard Spectra Chewable Tablets for dogs (Range)
Active substance: Afoxolaner
Milbemycin Oxime (A3 and A4)
Territory / Distribution category: NI POM-V
Authorisation holder: Boehringer Ingelheim Vetmedica Gmbh
Change category: Target species use
Summary of change:
Reduction in minimum bodyweight of animals to which Nexgard Spectra 9 mg/2 mg chewable tablets may be administered, from 2 kg to 1.35 kg (maximum bodyweight limit for this tablet strength remains as 3.5 kg). In the absence of available data, treatment of puppies less than 8 weeks of age and dogs less than 1.35 kg bodyweight with Nexgard Spectra chewable tablets should be based on a benefit-risk assessment by the responsible veterinarian.
Link to SPC to follow
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Solensia 7 mg/ml Solution for Injection for Cats
Active substance: Frunevetmab
Territory / Distribution category: NI POM-V
Authorisation holder: Zoetis Belgium
Change category: Adverse reactions
Summary of change:
Section 4.6: Addition of anaphylaxis as a very rare adverse event (<1 animal/10,000 animals treated, including isolated reports). In case of such reactions, appropriate symptomatic treatment should be administered.
Link to SPC to follow
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Vectra 3D Spot-on Solution for Dogs (Range)
Active substance: Dinotefuran, Permethrin (Cis:Trans 40:60), Pyriproxyfen
Territory / Distribution category: GB NFA-VPS
Authorisation holder: Ceva Animal Health Ltd
Change category: Modification of user safety warning
Summary of change:
Section 4.5ii: Modification of an existing user safety warning to read as follows: ‘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 4.5i: 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 2023
New Authorisations
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Cyclofin 300 mg/ml + 20 mg/ml Solution for Injection for Cattle
Active substance: Oxytetracycline, Flunixin
Territory / Distribution category: GB POM-V
Authorisation holder: Dechra Limited
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Tylolab Tartrate 200,000 IU/ml Solution for Injection [Cattle, Pigs]
Active substance: Tylosin tartrate
Territory / Distribution category: NI POM-V
Authorisation holder: Labiana Life Sciences SA
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Vey Tosal 100 mg/ml + 0.05 mg/ml Solution for Injection for Horses, Cattle, Dogs and Cats
Active substance: Butafosfan, Cyanocobalamin
Territory / Distribution category: NI POM-V
Authorisation holder: Veyx-Pharma GmbH
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Dormostop 5 mg/ml Solution for Injection for Dogs and Cats
Active substance: Atipamezole hydrochloride
Territory / Distribution category: GB POM-V
Authorisation holder: Alfasan Nederland B.V.
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NEOLEISH Solution for Nasal Spray for Dogs
Active substance: pPAL- LACK DNA plasmid (plasmid containing the sequence of Leishmania infantum LACK protein)
Territory / Distribution category: NI POM-V
Authorisation holder: CZ Veterinaria S.A.
Link NI SPC to follow
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Trilotab 10 mg / 30 mg / 60 mg / 120 mg / 150 mg Chewable Tablets for Dogs
Active substance: Trilostane
Territory / Distribution category: GB POM-V
Authorisation holder: CP Pharma Handelsgesellschaft mbH
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Vominil 10 mg/ml Solution for Injection for Dogs and Cats
Active substance: Maropitant
Territory / Distribution category: GB & NI POM-V
Authorisation holder: VetViva Richter GmbH
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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
Link to NI SPC to follow
Variations - food producing species
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Animeloxan 20 mg/ml Solution for Injection for Cattle, Pigs and Horses
Active substance: Meloxicam
Territory / Distribution category: GB & NI
Authorisation holder: aniMedica GmbH
Change category: Contraindications, Special warnings
Summary of change:
Section 4.5: NSAIDs and other prostaglandin inhibitors are known to have adverse effects on pregnancy and/or embryofoetal development. 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: 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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Baytril Piglet Doser 0.5% Oral Solution [Pigs]
Active substance: Enrofloxacin
Territory / Distribution category: UK POM-V
Authorisation holder: Elanco Europe Ltd
Change category: Contraindications, Special warnings
Summary of change:
Sections 4.5 and 4.8 have been largely aligned across these products, as appropriate.
Section 4.6: Relevant information added, as appropriate, on the occurrence of gastrointestinal, neurological and/or anaphylactic adverse events.
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Baytril 100 mg/ml Solution for Injection [Cattle, Goats, Pigs, Sheep]
Active substance: Enrofloxacin
Territory / Distribution category: UK POM-V
Authorisation holder: Elanco Europe Ltd
Change category: Contraindications, Special warnings
Summary of change:
Sections 4.5 and 4.8 have been largely aligned across these products, as appropriate.
Section 4.6: Relevant information added, as appropriate, on the occurrence of gastrointestinal, neurological and/or anaphylactic adverse events.
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Baytril 2.5% Oral Solution [Cattle, Exotic Animal, Reptiles]
Active substance: Enrofloxacin
Territory / Distribution category: UK POM-V
Authorisation holder: Elanco Europe Ltd UK
Change category: Contraindications, Special warnings
Summary of change:
Sections 4.5 and 4.8 have been largely aligned across these products, as appropriate.
Section 4.6: Relevant information added, as appropriate, on the occurrence of gastrointestinal, neurological and/or anaphylactic adverse events.
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Baytril 25 mg/ml Solution for Injection [Cats, Dogs, Ornamental Birds, Pigs, Rabbits, Reptiles, Rodents]
Active substance: Enrofloxacin
Territory / Distribution category: UK POM-V
Authorisation holder: Elanco Europe Ltd
Change category: Contraindications, Special warnings
Summary of change:
Sections 4.5 and 4.8 have been largely aligned across these products, as appropriate.
Section 4.6: Relevant information added, as appropriate, on the occurrence of gastrointestinal, neurological and/or anaphylactic adverse events.
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Baytril 50 mg/ml Solution for Injection [Cats, Cattle, Dogs, Goats, Pigs, Sheep]
Active substance: Enrofloxacin
Territory / Distribution category: UK POM-V
Authorisation holder: Elanco Europe Ltd
Change category: Contraindications, Special warnings
Summary of change:
Sections 4.5 and 4.8 have been largely aligned across these products, as appropriate.
Section 4.6: Relevant information added, as appropriate, on the occurrence of gastrointestinal, neurological and/or anaphylactic adverse events.
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Marbocyl 10% Solution for Injection [Cattle, Pigs]
Active substances: Marbofloxacin
Territory / Distribution category: UK POM-V
Authorisation holder: Vetoquinol UK Ltd
Change category: Contraindications, Special warnings
Summary of change:
Section 4.3: Do not use in cases of resistance to other fluoroquinolones (cross-resistance). Do not use in cases of hypersensitivity to the active substance, to any other quinolone or to any of the excipients.
Section 4.5: In case of contact with skin or eyes, rinse with plenty of water. Accidental self-injection can induce a slight irritation.
Section 4.10: No severe side-effects are to be expected at doses up to 3 or 5 times the recommended dose in cattle and pigs respectively.
Variations - companion animal species
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Baytril Flavour Tablets 15 mg [Cats, Dogs]
Active substances: Enrofloxacin
Territory / Distribution category: UK POM-V
Authorisation holder: Elanco Europe Ltd
Change category: Contraindications, Special warnings
Summary of change:
Sections 4.5 and 4.8 have been largely aligned across these products, as appropriate.
Section 4.6: Relevant information added, as appropriate, on the occurrence of gastrointestinal, neurological and/or anaphylactic adverse events.
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Baytril Flavour Tablets 50 mg [Dogs]
Active substances: Enrofloxacin
Territory / Distribution category: UK POM-V
Authorisation holder: Elanco Europe Ltd
Change category: Contraindications, Special warnings
Summary of change:
Sections 4.5 and 4.8 have been largely aligned across these products, as appropriate.
Section 4.6: Relevant information added, as appropriate, on the occurrence of gastrointestinal, neurological and/or anaphylactic adverse events.
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Bravecto Plus 112.5 mg/5.6 mg Spot-on Solution for Small Cats (1.2-2.8 kg)
Active substance: Fluralaner, Moxidectin
Territory / Distribution category: GB POM-V
Authorisation holder: MSD Animal Health UK Limited
Change category: Target species use
Summary of change:
Section 4.2: Prevention of aelurostrongylosis (by preventing the establishment of adult Aelurostrongylus abstrusus responsible for clinical disease).
Section 4.4: No therapeutic effect against adult A. abstrusus has been established. For the treatment of pre-existing infections with adult A. abstrusus, administration of a product authorised for treatment of adult A. abstrusus is required.
Section 4.9: To prevent the establishment of adult lungworms responsible for clinical aelurostrongylosis, cats need to be retreated at 12-week intervals.
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Bravecto Plus 250 mg/12.5 mg Spot-on Solution for Medium Cats (>2.8-6.25 kg)
Active substance: Fluralaner, Moxidectin
Territory / Distribution category: GB POM-V
Authorisation holder: MSD Animal Health UK Limited
Change category: Target species use
Summary of change:
Section 4.2: Prevention of aelurostrongylosis (by preventing the establishment of adult Aelurostrongylus abstrusus responsible for clinical disease).
Section 4.4: No therapeutic effect against adult A. abstrusus has been established. For the treatment of pre-existing infections with adult A. abstrusus, administration of a product authorised for treatment of adult A. abstrusus is required.
Section 4.9: To prevent the establishment of adult lungworms responsible for clinical aelurostrongylosis, cats need to be retreated at 12-week intervals.
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Bravecto Plus 500 mg/25 mg Spot-on Solution for Large Cats (>6.25-12.5 kg)
Active substance: Fluralaner, Moxidectin
Territory / Distribution category: GB POM-V
Authorisation holder: MSD Animal Health UK Limited
Change category: Target species use
Summary of change:
Section 4.2: Prevention of aelurostrongylosis (by preventing the establishment of adult Aelurostrongylus abstrusus responsible for clinical disease).
Section 4.4: No therapeutic effect against adult A. abstrusus has been established. For the treatment of pre-existing infections with adult A. abstrusus, administration of a product authorised for treatment of adult A. abstrusus is required.
Section 4.9: To prevent the establishment of adult lungworms responsible for clinical aelurostrongylosis, cats need to be retreated at 12-week intervals.
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Frontline Tri-Act Spot-on Solution for Dogs 2-5 kg / 5-10 kg / 10-20 kg / 20-40 kg / 40-60 kg
Active substance: Fipronil
Permethrin (Cis:Trans 40:60)
Territory / Distribution category: UK NFA-VPS
Authorisation holder: Boehringer Ingelheim Animal Health UK Ltd
Change category: Interactions
Summary of change:
Section 4.5: Warnings in relation to foetotoxicity, teratogenicity and pregnant women have been updated (for the three highest strength products only): 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 4.7 has been updated for all five products to: “Laboratory studies using fipronil or permethrin have not produced any evidence of teratogenic (capable of causing embryonic or foetal malformation) or embryotoxic (capable of causing toxicity to the embryo) effects. The safety of the veterinary medicinal product has not been established in dogs during pregnancy and 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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Librela 10 mg / 15 mg / 20 mg / 30 mg / 5 mg Solution for Injection for Dogs
Active substance: Bedinvetmab
Territory / Distribution category: GB POM-V
Authorisation holder: Zoetis UK Limited
Change category: Special warnings, Adverse reactions
Summary of change:
Section 4.5: Where a dog has not been able to properly exercise prior to treatment due to its clinical condition, it is recommended that the dog is gradually (over a few weeks) allowed to increase the amount of exercise they take (to prevent overexercise by some dogs).
Section 4.6: Polydipsia and polyuria have been added as rare adverse events. Hypersensitivity reactions (anaphylaxis, facial swelling, pruritus), immune-mediated haemolytic anaemia and immune-mediated thrombocytopenia have been added as very rare adverse events.
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Leucogen Suspension for Injection for Cats
Active substance: Feline leukemia virus
Territory / Distribution category: GB POM-V
Authorisation holder: Virbac
Change category: Special warnings, Adverse reactions
Summary of change:
Section 4.6: Vomiting and diarrhoea have been added as digestive disturbances commonly observed,
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Marbocyl P 5 mg Tablet [Cats, Dogs]
Active substance: Marbofloxacin
Territory / Distribution category: UK POM-V
Authorisation holder: Vetoquinol UK Ltd
Change category: Special warnings, Adverse reactions
Summary of change:
Section 4.3: Do not use in cases of hypersensitivity to fluoroquinolones or any of the excipients of the product. Do not use in cases of resistance against quinolones since (almost) complete cross-resistance exists against other fluoroquinolones.
Section 4.6: Joint pain and/or neurological symptoms (ataxia, aggression, convulsion, depression) may occur on rare occasions. Allergic reactions have been observed (temporary skin reactions) due to histamine release that may occur.
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Marbocyl P 20 mg / 80 mg Tablet [Dogs]
Active substance: Marbofloxacin
Territory / Distribution category: UK POM-V
Authorisation holder: Vetoquinol UK Ltd
Change category: Special warnings, Adverse reactions
Summary of change:
Section 4.3: Do not use in cases of hypersensitivity to fluoroquinolones or any of the excipients of the product. Do not use in cases of resistance against quinolones since (almost) complete cross-resistance exists against other fluoroquinolones.
Section 4.6: Joint pain and/or neurological symptoms (ataxia, aggression, convulsion, depression) may occur on rare occasions. Allergic reactions have been observed (temporary skin reactions) due to histamine release that may occur.
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Nobivac LeuFel Suspension for Injection for Cats
Active substance: Feline leukemia virus
Territory / Distribution category: GB POM-V
Authorisation holder: Virbac
Change category: Adverse reactions
Summary of change:
Section 4.6: Vomiting and diarrhoea have been added as digestive disturbances commonly observed.
Change of distribution category
The following products have a change of distribution category from POM-V to AVM-GSL.
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RSPCA FLEAaway Combo 50 mg/60 mg Spot-on Solution for Cats
Active substance: (S)-Methoprene, Fipronil
Territory / Distribution category: GB & NI
Authorisation holder: KRKA, d.d., Novo mesto
Change category: Distribution Category
Summary of change: Minor amendments due to a change in the distribution category from POM-V to AVM-GSL.
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RSPCA FLEAaway Combo 67 mg/ 60.3 mg Spot-on Solution for Small Dogs
Active substance: (S)-Methoprene, Fipronil
Territory / Distribution category: GB & NI
Authorisation holder: KRKA, d.d., Novo mesto
Change category: Distribution Catergory
Summary of change: Minor amendments due to a change in the distribution category from POM-V to AVM-GSL.
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RSPCA FLEAaway Combo 134 mg/ 120.6 mg Spot-on Solution for Medium Dogs
Active substance: (S)-Methoprene, Fipronil
Territory / Distribution category: GB & NI
Authorisation holder: KRKA, d.d., Novo mesto
Change category: Distribution Catergory
Summary of change: Minor amendments due to a change in the distribution category from POM-V to AVM-GSL.
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RSPCA FLEAaway Combo 268 mg/ 241.2 mg Spot-on Solution for Large Dogs
Active substance: (S)-Methoprene, Fipronil
Territory / Distribution category: GB & NI
Authorisation holder: KRKA, d.d., Novo mesto
Change category: Distribution Catergory
Summary of change: Minor amendments due to a change in the distribution category from POM-V to AVM-GSL.
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RSPCA FLEAaway Combo 402 mg/ 361.8 mg Spot-on Solution for Extra Large Dogs
Active substance: (S)-Methoprene, Fipronil
Territory / Distribution category: GB & NI
Authorisation holder: KRKA, d.d., Novo mesto
Change category: Distribution Catergory
Summary of change: Minor amendments due to a change in the distribution category from POM-V to AVM-GSL.