New and updated data sheets.
The following list of new and updated data sheets will be of interest to website users. The list is of those products that companies have chosen to highlight, and thus may not be exhaustive.
Product nameChange detailChange dateDatasheet
Eqvalan Duo, oral paste - UK(NI)Creation of separate UK(GB) and UK(NI) datasheets to reflect splitting of the UK licence10 June 2022Eqvalan Duo, oral paste - UK(NI)
Purevax RCPCh lyophilisate and solvent for suspension for injectionAddition of emesis (mostly within 24 to 48 hours) to adverse reactions section06 May 2022Purevax RCPCh lyophilisate and solvent for suspension for injection
Purevax RCPCh FeLV lyophilisate and solvent for suspension for injectionAddition of emesis (mostly within 24 to 48 hours) to adverse reactions section06 May 2022Purevax RCPCh FeLV lyophilisate and solvent for suspension for injection
Purevax RCP lyophilisate and solvent for suspension for injectionAddition of emesis (mostly within 24 to 48 hours) to adverse reactions section06 May 2022Purevax RCP lyophilisate and solvent for suspension for injection
Purevax RCP FeLV lyophilisate and solvent for suspension for injectionAddition of emesis (mostly within 24 to 48 hours) to adverse reactions section06 May 2022Purevax RCP FeLV lyophilisate and solvent for suspension for injection
Purevax RC lyophilisate and solvent for suspension for injectionAddition of emesis (mostly within 24 to 48 hours) to adverse reactions section06 May 2022Purevax RC lyophilisate and solvent for suspension for injection
Pen & Strep Suspension for InjectionClinical particulars: Adverse reactions (frequency & seriousness) - text has been updated
Pharmacological particulars - ATCvet Code: Updated from QJ5RC03 to QJ01RA01
13 April 2022Pen & Strep Suspension for Injection
Buscopan Compositum Solution for InjectionChange in shelf life from 4 years to 3 years26 April 2022Buscopan Compositum Solution for Injection
Sedivet 10 mg/ml solution for injection for horsesChange in shelf life from 5 years to 3 years26 April 2022Sedivet 10 mg/ml solution for injection for horses
Tralieve® Chewable Tablets for DogsMAH Change from Le Vet Beheer BV to Dechra Regulatory BV07 April 2022Tralieve® Chewable Tablets for Dogs
Prednicortone® 5 mg Tablets for Dogs and CatsMAH Change from Le Vet Beheer BV to Dechra Regulatory BV07 April 2022Prednicortone® 5 mg Tablets for Dogs and Cats
Metrobactin® Tablets for Dogs and CatsMAH Change from Le Vet Beheer BV to Dechra Regulatory BV07 April 2022Metrobactin® Tablets for Dogs and Cats
Denagard 200 mg/ml Solution for InjectionWithdrawal period has been decreased from 28 days to 22 days11 March 2022Denagard 200 mg/ml Solution for Injection
Poulvac E.coli lyophilisate for suspension for spray vaccination for chickens and turkeys or for use in drinking water for chickensRemove contraindication for use during lay17 March 2022Poulvac E.coli lyophilisate for suspension for spray vaccination for chickens and turkeys or for use in drinking water for chickens
Apoquel chewable tablets for dogsNew product09 March 2022Apoquel chewable tablets for dogs
Betamox LA 150 mg/ml Suspension for InjectionChange to Clinical Particulars - Adverse Reactions (frequency & seriousness) - see datasheet08 March 2022Betamox LA 150 mg/ml Suspension for Injection
Respiporc® FLUpan H1N1 suspension for injection for pigsUpdate regarding use in pregnancy and lactation01 March 2022Respiporc® FLUpan H1N1 suspension for injection for pigs
Ronaxan 20mg, 100mg TabletShelf life increased from 2 years to 3 years27 January 2022Ronaxan 20mg, 100mg Tablet
Ronaxan 20mg, 100mg TabletUpdates to pharmacodynamics/pharmacokinetics sections to reflect updated info27 January 2022Ronaxan 20mg, 100mg Tablet
Ronaxan 20mg, 100mg TabletUpdate to interaction with other medicines section - anticoagulant therapy27 January 2022Ronaxan 20mg, 100mg Tablet
Ronaxan 20mg, 100mg TabletChange in adverse reactions section27 January 2022Ronaxan 20mg, 100mg Tablet
Ronaxan 20mg, 100mg TabletAddition of information on special precautions for use27 January 2022Ronaxan 20mg, 100mg Tablet
Ronaxan 20mg, 100mg TabletAddition of special warnings for target species: dogs, with respect to treating Ehrlichia Canis infections27 January 2022Ronaxan 20mg, 100mg Tablet
Ronaxan 20mg, 100mg TabletAddition of contraindications: Do not use in animals with hepatic insufficiency, animals with diseases associated with vomiting or dysphagia, animals with known photosensitivity, or in puppies and kittens before completion of teeth enamel formation.27 January 2022Ronaxan 20mg, 100mg Tablet
Ronaxan 20mg, 100mg TabletRemoval of indication to treat infections caused by Staphylococcus and Streptococcus spp in dogs27 January 2022Ronaxan 20mg, 100mg Tablet
Ronaxan 20mg, 100mg TabletAddition of cats as target species (100 mg only)27 January 2022Ronaxan 20mg, 100mg Tablet
NexGard Combo spot-on solution for cats <2.5 kg and NexGard Combo spot-on solution for cats 2.5-7.5 kgAddition of use in breeding, pregnant and lactating queens.22 December 2021NexGard Combo spot-on solution for cats <2.5 kg and NexGard Combo spot-on solution for cats 2.5-7.5 kg
NexGard Combo spot-on solution for cats <2.5 kg and NexGard Combo spot-on solution for cats 2.5-7.5 kgAddition of indication: treatment of infections with L3, L4 larvae and adults of Aelurostrongylus abstrusus22 December 2021NexGard Combo spot-on solution for cats <2.5 kg and NexGard Combo spot-on solution for cats 2.5-7.5 kg
NexGard Combo spot-on solution for cats <2.5 kg and NexGard Combo spot-on solution for cats 2.5-7.5 kgAddition of indication: treatment of Notoedric mange (caused by Notoedres cati).22 December 2021NexGard Combo spot-on solution for cats <2.5 kg and NexGard Combo spot-on solution for cats 2.5-7.5 kg
UBAC Emulsion for Injection for CattleAddition of anaphylactic-type reactions to adverse reactions warnings21 December 2021UBAC Emulsion for Injection for Cattle
Felpreva Spot on Solution for CatsNew Marketing Authorisation18 November 2021Felpreva Spot on Solution for Cats
Equipalazone® 1 g Oral Powder for Horses and PoniesNew product08 October 2021Equipalazone® 1 g Oral Powder for Horses and Ponies
Vetoryl® Hard Capsules for DogsAddition of 5mg strength08 October 2021Vetoryl® Hard Capsules for Dogs
Sympagesic® 500 mg/ml + 4 mg/ml Solution for Injection for Horses, Cattle, Pigs and DogsNew product08 October 2021Sympagesic® 500 mg/ml + 4 mg/ml Solution for Injection for Horses, Cattle, Pigs and Dogs
Rexxolide® 100 mg/ml Solution for Injection for Cattle, Pigs and SheepNew product08 October 2021Rexxolide® 100 mg/ml Solution for Injection for Cattle, Pigs and Sheep
Prevomax® 10 mg/ml Solution for Injection for Dogs and CatsChange of NI MAH from Le Vet Beheer to Dechra Regulatory BV08 October 2021Prevomax® 10 mg/ml Solution for Injection for Dogs and Cats
Mirataz® 20 mg/g Transdermal Ointment for CatsNew product08 October 2021Mirataz® 20 mg/g Transdermal Ointment for Cats
Metrobactin® Tablets for Dogs and CatsSafety related update to SPC08 October 2021Metrobactin® Tablets for Dogs and Cats
Equisolon® Oral Powder for HorsesNew product08 October 2021Equisolon® Oral Powder for Horses
Equibactin® 250 mg/g + 50 mg/g Oral Powder for HorsesNew product08 October 2021Equibactin® 250 mg/g + 50 mg/g Oral Powder for Horses
Avishield® ND, Lyophilisate for Oculonasal Suspension/Use in Drinking Water for Chickens and TurkeysMinor change to name and updated text08 October 2021Avishield® ND, Lyophilisate for Oculonasal Suspension/Use in Drinking Water for Chickens and Turkeys
Avishield® IBD Plus Lyophilisate for Use in Drinking Water for ChickensNew product08 October 2021Avishield® IBD Plus Lyophilisate for Use in Drinking Water for Chickens
FIPROtec® Spray 2.5 mg/ml Cutaneous Spray, Solution for Cats and Dogs (GB)Legal Category29 September 2021FIPROtec® Spray 2.5 mg/ml Cutaneous Spray, Solution for Cats and Dogs (GB)
Canishield® Medicated Collar for Dogs (GB)Legal Category29 September 2021Canishield® Medicated Collar for Dogs (GB)
Arti-Cell Forte suspension for injection for horsesChange in Marketing Authoristion Holder07 July 2021Arti-Cell Forte suspension for injection for horses
Mepidor 20mg/ml InjectionAt the time of renewal there has been a change in the wording of Section 4.7 to include additional information21 September 2021Mepidor 20mg/ml Injection
PROGRAM Plus film-coated tablets 23mg/460 mgReduction in shelf life from 5 to 3 years16 September 2021PROGRAM Plus film-coated tablets 23mg/460 mg
PROGRAM Plus film-coated tablets 11.5mg/230 mgReduction in shelf life from 5 to 3 years16 September 2021PROGRAM Plus film-coated tablets 11.5mg/230 mg
PROGRAM Plus film-coated tablets 5.75mg/115 mgReduction in shelf life from 5 to 3 years16 September 2021PROGRAM Plus film-coated tablets 5.75mg/115 mg
PROGRAM Plus film-coated tablets 2.3mg/46 mgReduction in shelf life from 5 to 3 years16 September 2021PROGRAM Plus film-coated tablets 2.3mg/46 mg
Thyronorm 5 mg/ml Oral Solution for CatsClinical Particulars/Adverse reactions (frequency & seriousness): additional paragraph added14 September 2021Thyronorm 5 mg/ml Oral Solution for Cats
Thyronorm 5 mg/ml Oral Solution for CatsClinical Particulars/Special precautions for use: additional line 'In hyperthyroid cats, gastrointestinal disorders are common and may interfere with the success of the oral therapy.'14 September 2021Thyronorm 5 mg/ml Oral Solution for Cats
Noropraz, 18.7 mg/g + 140.3 mg/g Oral Paste for HorsesClinical Particulars/Adverse reactions (frequency & seriousness) - additional paragraph added14 September 2021Noropraz, 18.7 mg/g + 140.3 mg/g Oral Paste for Horses
Noromectin 1.87% Oral Paste for HorsesPharmaceutical particulars/List of Excipient(s) - added Water for injection14 September 2021Noromectin 1.87% Oral Paste for Horses
Norocillin 30% w/v Suspension for InjectionClinical Particulars/Adverse reactions (frequency & seriousness) additional paragraph added14 September 2021Norocillin 30% w/v Suspension for Injection
Loxicom 5 mg/ml Solution for Injection for Dogs and CatsClinical Particulars/Adverse Reactions (frequency & seriousness) - additional line "In very rare cases elevated liver enzymes have been reported".14 September 2021Loxicom 5 mg/ml Solution for Injection for Dogs and Cats
Loxicom 20 mg/ml Solution for Injection for Cattle, Pigs and HorsesAdditional paragraph, "Withdrawal period(s)" added to Clinical Particulars section14 September 2021Loxicom 20 mg/ml Solution for Injection for Cattle, Pigs and Horses
Combiclav Lactating Cow Intramammary SuspensionWithdrawal notes updated14 September 2021Combiclav Lactating Cow Intramammary Suspension
Bovalto Respi IntranasalAddition of a 10-dose presentation.03 September 2021Bovalto Respi Intranasal
Eprinex Multi 5 mg/ml pour-on solution for cattle, sheep and goatsRenewal (multiple changes): Name change from 'Eprinex Multi 5mg/ml pour-on for beef and dairy cattle, sheep and goats' to 'Eprinex Multi 5mg/ml pour-on solution for cattle, sheep and goats'. The following wording has moved from 'Special Precautions for use in Animals' to 'Contraindications' - "Avermectins can cause fatalities in dogs, especially Collies, Old English Sheepdogs and related breeds and crosses, and also in turtles/tortoises." In 'Other Precautions' the following text has been updated to "In order to reduce the risk to aquatic ecosystems, treated animals should not have direct access to water bodies for a minimum of two to five weeks after treatment." In 'Amounts to be administered and administration route' the wording "For single application only" has been added and "All the animals belonging to the same group should be treated at the same time." Multiple changes to the "Method of Administration" section under the 'For 250ml and 2litre bottles' and 'For 2.5 and 5 litre back-pack' headings to improve clarity. Addition of the following wording to "Environmental Properties" - "Eprinomectin is very toxic to aquatic organisms, is persistent in soils and may accumulate in sediments." The following wording has been added to Disposal Section "Extremely dangerous to fish and aquatic life".03 September 2021Eprinex Multi 5 mg/ml pour-on solution for cattle, sheep and goats
Lydaxx 100 mg/ml solution for injection for cattle, pigs and sheepAlignment of the product information to the product information of the reference product01 July 2021Lydaxx 100 mg/ml solution for injection for cattle, pigs and sheep
Solantel 200mg/ml Pour-On Solution for CattleNew Product23 August 2021Solantel 200mg/ml Pour-On Solution for Cattle
Daxocox tablets for dogsNew Product13 July 2021Daxocox tablets for dogs
Kesium® 40mg/10mg & 50mg/12.5mg chewable tablets for cats & dogs and Kesium® 200mg/50mg, 400mg/100mg & 500mg/125mg chewable tablets for dogsName Changes for Kesium range - product names changed throughout SPC07 July 2021Kesium® 40mg/10mg & 50mg/12.5mg chewable tablets for cats & dogs and Kesium® 200mg/50mg, 400mg/100mg & 500mg/125mg chewable tablets for dogs
Versifel® FeLV suspension for injection for catsNew Datasheet07 July 2021Versifel® FeLV suspension for injection for cats
Vetbromide 600mg tablets for dogsNEW PRODUCT05 July 2021Vetbromide 600mg tablets for dogs
Rispoval 2 / BRSV + Pi3 Lyophilisate and solvent for suspension for injection for cattleNew Product01 July 2021Rispoval 2 / BRSV + Pi3 Lyophilisate and solvent for suspension for injection for cattle
Pracetam® 400 mg/ml solution for use in drinking water for pigsUpdated text throughout Clinical particulars including; special precautions for use, adverse reactions, use during pregnancy and lactation, amounts to be administered and overdose.28 June 2021Pracetam® 400 mg/ml solution for use in drinking water for pigs
Emeprid® 5 mg/ml solution for injection for dogs and catsAdverse Reactions- text updated28 June 2021Emeprid® 5 mg/ml solution for injection for dogs and cats
Product nameChange detailChange dateDatasheet