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
Somulose® Solution for InjectionChange of MAH to Dechra Regulatory BV from Dechra Limited13 February 2025Somulose® Solution for Injection
Intra-Epicaine 20 mg/ml Solution for Injection for HorsesChange of MAH to Dechra Regulatory BV from Dechra Limited13 February 2025Intra-Epicaine 20 mg/ml Solution for Injection for Horses
Regumate® Equine 2.2 mg/ml oral solution for horsesUpdated MA holder different from distributor, Vm number, date of revision of the text24 April 2025Regumate® Equine 2.2 mg/ml oral solution for horses
Vecoxan® 2.5 mg/ml Oral SuspensionUpdated MA holder different from distributor, Vm number, date of revision of the text23 April 2025Vecoxan® 2.5 mg/ml Oral Suspension
BRAVECTO® TriUNO chewable tablets for dogs (GB)New datasheet16 April 2025BRAVECTO® TriUNO chewable tablets for dogs (GB)
BRAVECTO® TriUNO chewable tablets for dogs (NI)New datasheet16 April 2025BRAVECTO® TriUNO chewable tablets for dogs (NI)
Libromide® 325 mg Tablets for DogsChange of MAH to Dechra Regulatory BV from Dechra Limited13 February 2025Libromide® 325 mg Tablets for Dogs
Pardale-V™ Oral TabletsChange of MAH to Dechra Regulatory BV from Dechra Limited13 February 2025Pardale-V™ Oral Tablets
Porcilis® Glässer Suspension for injection for pigsUpdated MA holder different from distributor, Vm number, date of revision of the text11 April 2025Porcilis® Glässer Suspension for injection for pigs
Prinovox Spot On solution for Cats and FerretsAddition of the indication against the cat lungworm Troglostrongylus brevior (adults), with associated dosing and warning.30 January 2025Prinovox Spot On solution for Cats and Ferrets
Kriptazen 0.5 mg/ml oral solution for calvesExtension of a re-test period/storage period supported by real time data.05 March 2025Kriptazen 0.5 mg/ml oral solution for calves
Cepralock® 2.6 g Intramammary Suspension for Dry CowsComplete template update10 April 2025Cepralock® 2.6 g Intramammary Suspension for Dry Cows
Paracox®-8 suspension for oral suspension for chickensUpdated MA holder different from distributor, Vm number, date of revision of the text10 April 2025Paracox®-8 suspension for oral suspension for chickens
Posatex® ear drops suspension for dogsComplete template update27 March 2025Posatex® ear drops suspension for dogs
Bravoxin® suspension for injection for cattle and sheepUpdated MA holder different from distributor, Vm number, date of revision of the text25 March 2025Bravoxin® suspension for injection for cattle and sheep
Bovilis® Rotavec® Corona Emulsion for Injection for Cattle (NI)Updated MA holder different from distributor, Vm number, date of revision of the text25 March 2025Bovilis® Rotavec® Corona Emulsion for Injection for Cattle (NI)
Zitac® vet 100 mg tablets for dogs
Zitac® vet 200 mg tablets for dogs		Complete template update25 March 2025Zitac® vet 100 mg tablets for dogs
Zitac® vet 200 mg tablets for dogs
Tetanus Antitoxin BehringUpdated MA holder different from distributor, date of revision of the text25 March 2025Tetanus Antitoxin Behring
Regumate® Equine 2.2 mg/ml oral solution for horsesComplete template update24 March 2025Regumate® Equine 2.2 mg/ml oral solution for horses
Otomax® Ear Drops SuspensionComplete template update.24 March 2025Otomax® Ear Drops Suspension
Vidalta® 10 mg prolonged-release tablets for cats
Vidalta® 15 mg prolonged-release tablets for cats		Complete template update24 March 2025Vidalta® 10 mg prolonged-release tablets for cats
Vidalta® 15 mg prolonged-release tablets for cats
Multimin Solution for Injection for CattleUpdated Sections 4.6 and 4.10 based on the results of TAS studies.20 December 2024Multimin Solution for Injection for Cattle
Nuflor® 300 mg/ml solution for injection for cattle and sheepComplete template update including updated MA numbers17 March 2025Nuflor® 300 mg/ml solution for injection for cattle and sheep
Bovilis Nasalgen®-C nasal spray, lyophilisate and solvent for suspension for cattle (GB)Update of QRDv9 template from v1 to v3 and addition of use during pregnancy.17 March 2025Bovilis Nasalgen®-C nasal spray, lyophilisate and solvent for suspension for cattle (GB)
Nobivac® Respira Bb suspension for injection for dogsChanges to Marketing Authorisation Holder (if different from distributor), Marketing authorisation number and Date of revision of the text07 March 2025Nobivac® Respira Bb suspension for injection for dogs
AquaVac® 6 emulsion for injection for Atlantic salmonChanges to Marketing Authorisation Holder (if different from distributor), Marketing authorisation number and Date of revision of the text07 March 2025AquaVac® 6 emulsion for injection for Atlantic salmon
Zitac® vet 100 mg tablets for dogs
Zitac® vet 200 mg tablets for dogs		Corrected active ingredients07 March 2025Zitac® vet 100 mg tablets for dogs
Zitac® vet 200 mg tablets for dogs
Bovilis® Bovipast® RSP suspension for injection for cattleChanges to Marketing Authorisation Holder (if different from distributor), Marketing authorisation number and Date of revision of the text04 March 2025Bovilis® Bovipast® RSP suspension for injection for cattle
CepraShort® 300 mg Intramammary Suspension for dairy cows at drying-offChanges to Marketing Authorisation Holder (if different from distributor), Marketing authorisation number and Date of revision of the text04 March 2025CepraShort® 300 mg Intramammary Suspension for dairy cows at drying-off
Porcilis® PRRS lyophilisate and solvent for suspension for injection for pigsChanges to Marketing Authorisation Holder (if different from distributor), Marketing authorisation number and Date of revision of the text28 February 2025Porcilis® PRRS lyophilisate and solvent for suspension for injection for pigs
Porcilis® Lawsonia lyophilisate and solvent for emulsion for injection for pigsChanges to Marketing Authorisation Holder (if different from distributor), Marketing authorisation number and Date of revision of the text28 February 2025Porcilis® Lawsonia lyophilisate and solvent for emulsion for injection for pigs
Porcilis​® Ery+Parvo+Lepto suspension for injection for pigsChanges to Marketing Authorisation Holder (if different from distributor), Marketing authorisation number and Date of revision of the text28 February 2025Porcilis​® Ery+Parvo+Lepto suspension for injection for pigs
Porcilis® Ery suspension for injectionChanges to Marketing Authorisation Holder (if different from distributor), Marketing authorisation number and Date of revision of the text28 February 2025Porcilis® Ery suspension for injection
Porcilis® APP Suspension for injectionChanges to Marketing Authorisation Holder (if different from distributor), Marketing authorisation number and Date of revision of the text28 February 2025Porcilis® APP Suspension for injection
Finadyne® 50 mg/g oral pasteChanges to Marketing Authorisation Holder (if different from distributor), Marketing authorisation number and Date of revision of the text28 February 2025Finadyne® 50 mg/g oral paste
Regumate® Porcine 0.4 % w/v oral solutionChanges to Marketing Authorisation Holder (if different from distributor), Marketing authorisation number and Date of revision of the text28 February 2025Regumate® Porcine 0.4 % w/v oral solution
PG 600™ Powder and solvent for solution for injectionChanges to Marketing Authorisation Holder (if different from distributor), Marketing authorisation number and Date of revision of the text28 February 2025PG 600™ Powder and solvent for solution for injection
Panacur® Equine Oral Paste 18.75 % w/wChanges to Marketing Authorisation Holder (if different from distributor), Marketing authorisation number and Date of revision of the text28 February 2025Panacur® Equine Oral Paste 18.75 % w/w
Panacur® Equine Guard 10% w/v Oral SuspensionChanges to Marketing Authorisation Holder (if different from distributor), Marketing authorisation number and Date of revision of the text28 February 2025Panacur® Equine Guard 10% w/v Oral Suspension
Panacur® Equine Granules 22.2% w/wChanges to Marketing Authorisation Holder (if different from distributor), Marketing authorisation number and Date of revision of the text28 February 2025Panacur® Equine Granules 22.2% w/w
Dimazon® 50 mg/ml Solution for InjectionChanges to Marketing Authorisation Holder (if different from distributor), Marketing authorisation number and Date of revision of the text28 February 2025Dimazon® 50 mg/ml Solution for Injection
Chorulon® 1500 IU Powder and Solvent for Solution for injectionChanges to Marketing Authorisation Holder (if different from distributor), Marketing authorisation number and Date of revision of the text28 February 2025Chorulon® 1500 IU Powder and Solvent for Solution for injection
CLYNAV® solution for injectionNew datasheet25 February 2025CLYNAV® solution for injection
Vetoryl® Hard Capsules for DogsChange of MAH to Dechra Regulatory BV from Dechra Limited06 February 2025Vetoryl® Hard Capsules for Dogs
Nobilis® IB+ND+EDS emulsion for injection (UK)New datasheet.24 February 2025Nobilis® IB+ND+EDS emulsion for injection (UK)
Nobilis® Diluent Oculo NasalNew datasheet24 February 2025Nobilis® Diluent Oculo Nasal
Nobilis® ErysipelasChanges to Marketing Authorisation Holder (if different from distributor), Marketing authorisation number and Date of revision of the text24 February 2025Nobilis® Erysipelas
Nobilis® Rismavac + CA126Changes to Marketing Authorisation Holder (if different from distributor), Marketing authorisation number and Date of revision of the text24 February 2025Nobilis® Rismavac + CA126
Nobilis® RismavacChanges to Marketing Authorisation Holder (if different from distributor), Marketing authorisation number and Date of revision of the text24 February 2025Nobilis® Rismavac
Nobilis® Salenvac ETC suspension for injection for chickensChanges to Marketing Authorisation Holder (if different from distributor), Marketing authorisation number and Date of revision of the text24 February 2025Nobilis® Salenvac ETC suspension for injection for chickens
Nobilis® REO Inac Emulsion for InjectionChanged MA Holder different from distributor, Vm number update and Date of change20 February 2025Nobilis® REO Inac Emulsion for Injection
Nobivac® SolventChanged MA Holder different from distributor, Vm number update and Date of change20 February 2025Nobivac® Solvent
Florocol® Premix for Medicated Feeding stuff 500 mg/g for Atlantic SalmonChanged MA Holder different from distributor, Vm number update and Date of change20 February 2025Florocol® Premix for Medicated Feeding stuff 500 mg/g for Atlantic Salmon
Slice® 2 mg/g premix for medicated feeding stuff for Atlantic salmonChanged MA Holder different from distributor, Vm number update and Date of change20 February 2025Slice® 2 mg/g premix for medicated feeding stuff for Atlantic salmon
Porcilis® Glässer Suspension for injection for pigsComplete template update19 February 2025Porcilis® Glässer Suspension for injection for pigs
Nuflor® Minidose 450 mg/ml solution for injection for cattleUpdate to Section Indications and Date of Revision of the text14 February 2025Nuflor® Minidose 450 mg/ml solution for injection for cattle
Panacur® Small Animal 10% Oral SuspensionUpdate to immediate packaging and Date of revision14 February 2025Panacur® Small Animal 10% Oral Suspension
Stelfonta 1 mg/ml solution for injection for dogsAddition of a new therapeutic indication or modification of an approved one.19 January 2025Stelfonta 1 mg/ml solution for injection for dogs
Nobivac® DHPPi Lyophilisate for Suspension for Injection for DogsChanged MA Holder different from distributor, Vm number update and Date of change11 February 2025Nobivac® DHPPi Lyophilisate for Suspension for Injection for Dogs
Nobivac® Parvo-C Lyophilisate for suspension for injection for dogsChanged MA Holder different from distributor, Vm number update and Date of change11 February 2025Nobivac® Parvo-C Lyophilisate for suspension for injection for dogs
Nobivac® Rabies Suspension for injectionChanged MA Holder different from distributor, Vm number update and Date of change11 February 2025Nobivac® Rabies Suspension for injection
Bovilis® IBR Marker Live lyophilisate and solvent for suspension for cattleChanged MA Holder different from distributor, Vm number update and Date of change07 February 2025Bovilis® IBR Marker Live lyophilisate and solvent for suspension for cattle
Bovilis® HuskvacChanged MA Holder different from distributor, Vm number update and Date of change07 February 2025Bovilis® Huskvac
Bovilis® INtranasal RSP™ Live nasal spray, lyophilisate and solvent for suspension for cattleChanged MA Holder different from distributor, Vm number update and Date of change07 February 2025Bovilis® INtranasal RSP™ Live nasal spray, lyophilisate and solvent for suspension for cattle
Bovilis® BVD Suspension for Injection for CattleChanged MA Holder different from distributor, Vm number update and Date of change07 February 2025Bovilis® BVD Suspension for Injection for Cattle
Alizin 30mg/ml solution for injection (GB)Updated statements in 4.5i and 4.6 regarding rare cases of lack of efficacy which could lead to dystocia or uterine rupture and very rarely to fatal outcome.11 January 2025Alizin 30mg/ml solution for injection (GB)
Clomicalm Tablets for Dogs (GB only)To revise the SPC section 4.6 & QRD section 6: Adding diarrhoea, mydriasis, aggression and convulsion adverse events associated to a “very rare” frequency.22 January 2025Clomicalm Tablets for Dogs (GB only)
Engemycin® Spray, 25mg/ml, cutaneous spray, suspension for cattle, sheep and pigsChanged MA Holder different from distributor, Vm number update and Date of change05 February 2025Engemycin® Spray, 25mg/ml, cutaneous spray, suspension for cattle, sheep and pigs
Engemycin® 10% Farm Pack Solution for injectionChanged MA Holder different from distributor, Vm number update and Date of change05 February 2025Engemycin® 10% Farm Pack Solution for injection
Engemycin® 10% DD Solution for injectionChanged MA Holder different from distributor, Vm number update and Date of change05 February 2025Engemycin® 10% DD Solution for injection
Heptavac® P Plus suspension for injection for sheepChanged MA Holder different from distributor, Vm number update and Date of change04 February 2025Heptavac® P Plus suspension for injection for sheep
Bovilis® Bovivac® SChanged MA Holder different from distributor, Vm number update and Date of change04 February 2025Bovilis® Bovivac® S
Vecoxan® 2.5 mg/ml Oral SuspensionUpdate to immediate packaging only.04 February 2025Vecoxan® 2.5 mg/ml Oral Suspension
Felimazole® 5 mg/ml Oral Solution for CatsNew Product02 October 2024Felimazole® 5 mg/ml Oral Solution for Cats
Cobactan® MC Intramammary suspension 75 mg Milking cowChanged MA Holder different from distributor, Vm number update and Date of change31 January 2025Cobactan® MC Intramammary suspension 75 mg Milking cow
Cepravin® Dry Cow 250mg Intramammary suspensionChanged MA Holder different from distributor, Vm number update and Date of change31 January 2025Cepravin® Dry Cow 250mg Intramammary suspension
Ceporex® 180 mg/ml Suspension for injection for cattle, cats and dogsChanged MA Holder different from distributor, Vm number update and Date of change31 January 2025Ceporex® 180 mg/ml Suspension for injection for cattle, cats and dogs
Optimmune 2 mg/g Eye OintmentChanged MA Holder different from distributor, Vm number update and Date of change28 January 2025Optimmune 2 mg/g Eye Ointment
Sedaxylan® 20 mg/ml Solution for Injection for Dogs, Cats, Horses and CattleLegal Category updated to CD(Sch 4 Pt 1)15 January 2025Sedaxylan® 20 mg/ml Solution for Injection for Dogs, Cats, Horses and Cattle
Nerfasin® Solution for InjectionLegal Category updated to CD(Sch 4 Pt 1)15 January 2025Nerfasin® Solution for Injection
Porcilis® APP Suspension for injectionComplete template update.20 January 2025Porcilis® APP Suspension for injection
Nobilis® Gumboro 228E lyophilisate for use in drinking water for chickensChanged MA Holder different from distributor, Vm number update and Date of change20 January 2025Nobilis® Gumboro 228E lyophilisate for use in drinking water for chickens
Exzolt® 10 mg/ml solution for use in drinking water for chickens (GB)Complete template update20 January 2025Exzolt® 10 mg/ml solution for use in drinking water for chickens (GB)
Exzolt 10 mg/ml solution for use in drinking water for chickens (NI)New datasheet20 January 2025Exzolt 10 mg/ml solution for use in drinking water for chickens (NI)
Bovilis® Bovipast® RSP suspension for injection for cattleComplete template update with changes to most sections.16 January 2025Bovilis® Bovipast® RSP suspension for injection for cattle
Lambivac®Changed MA Holder different from distributor, Vm number update and Date of change16 January 2025Lambivac®
Footvax®Changed MA Holder different from distributor, Vm number update and Date of change16 January 2025Footvax®
CepraShort® 300 mg Intramammary Suspension for dairy cows at drying-offComplete template update with changes to most sections.15 January 2025CepraShort® 300 mg Intramammary Suspension for dairy cows at drying-off
Itrafungol 10 mg/ml Oral Solution (NI)Change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet to implement the outcome of the MAH’s signal management process.22 December 2024Itrafungol 10 mg/ml Oral Solution (NI)
Porcilis® AR-T DF suspension for injection for pigsUpdates to Pharmaceutical form, Adverse reactions, Pharmaceutical particulars, MA holder, MA numbers, Date of revision13 January 2025Porcilis® AR-T DF suspension for injection for pigs
Nobilis® Gumboro D78 lyophilisate for oculonasal suspension/use in drinking water for chickensChanged MA Holder different from distributor, Vm number update and Date of change13 January 2025Nobilis® Gumboro D78 lyophilisate for oculonasal suspension/use in drinking water for chickens
Nobilis® Ma5 + Clone 30 lyophilisate for oculonasal suspension/use in drinking water for chickensChanged MA Holder different from distributor, Vm number update and Date of change13 January 2025Nobilis® Ma5 + Clone 30 lyophilisate for oculonasal suspension/use in drinking water for chickens
Nobilis® Ma5 + Clone 30 lyophilisate for oculonasal suspension/use in drinking water for chickensChanged MA Holder different from distributor, Vm number update and Date of change13 January 2025Nobilis® Ma5 + Clone 30 lyophilisate for oculonasal suspension/use in drinking water for chickens
Nobilis® E Coli Inac emulsion for injection for chickensChanged MA Holder different from distributor, Vm number update and Date of change13 January 2025Nobilis® E Coli Inac emulsion for injection for chickens
Nobilis® RT+IBmulti+ND+EDSChanged MA Holder different from distributor, Vm number update and Date of change13 January 2025Nobilis® RT+IBmulti+ND+EDS
Nobilis® RT+IBmulti+G+NDChanged MA Holder different from distributor, Vm number update and Date of change13 January 2025Nobilis® RT+IBmulti+G+ND
Nuflor® 40 mg/g Premix for Medicated Feeding Stuff for SwineChanges to Pharmaceutical form, Target species, Contraindications, Special precautions for use, Operator warnings, Adverse reactions, Dosage, Administration, Pharmacodynamic properties, Pharmaceutical particulars, MA numbers, Date of revision of the text10 January 2025Nuflor® 40 mg/g Premix for Medicated Feeding Stuff for Swine
Laurabolin® 25 mg/ml, solution for injectionChanged MA Holder different from distributor, Vm number update and Date of change10 January 2025Laurabolin® 25 mg/ml, solution for injection
Caninsulin 40 IU/ml Suspension for InjectionChanged MA Holder different from distributor, Vm number update and Date of change10 January 2025Caninsulin 40 IU/ml Suspension for Injection
Scalibor® Protectorband 0.76 g medicated collar for small and medium dogs and
Scalibor® Protectorband 1.0 g medicated collar for large dogs		Changed MA Holder different from distributor, Vm number update and Date of change10 January 2025Scalibor® Protectorband 0.76 g medicated collar for small and medium dogs and
Scalibor® Protectorband 1.0 g medicated collar for large dogs
Finadyne® 50mg/ml Solution for InjectionChanged MA Holder different from distributor, Vm number update and Date of change09 January 2025Finadyne® 50mg/ml Solution for Injection
Panacur® Bolus, 12 g Continuous Release Intraruminal DeviceChanged MA Holder different from distributor, Vm number update and Date of change09 January 2025Panacur® Bolus, 12 g Continuous Release Intraruminal Device
Dexafort® suspension for injectionChanged MA Holder different from distributor, Vm number update and Date of change09 January 2025Dexafort® suspension for injection
Dexadreson® 2 mg/ml solution for injectionChanged MA Holder different from distributor, Vm number update and Date of change09 January 2025Dexadreson® 2 mg/ml solution for injection
Oxytocin-S, 10 iu/ml, solution for injectionChanged MA Holder different from distributor, Vm number update and Date of change09 January 2025Oxytocin-S, 10 iu/ml, solution for injection
Neopen® suspension for injectionChanged MA Holder different from distributor, Vm number update and Date of change09 January 2025Neopen® suspension for injection
Chronogest CR® 20 mg controlled release vaginal sponge for sheepChanged MA Holder different from distributor, Vm number update and Date of change09 January 2025Chronogest CR® 20 mg controlled release vaginal sponge for sheep
Resflor® 300/16.5 mg/ml Solution for Injection for CattleChanged MA Holder different from distributor, Vm number update and Date of change09 January 2025Resflor® 300/16.5 mg/ml Solution for Injection for Cattle
Metricure® 500 mg Intrauterine SuspensionChanged MA Holder different from distributor, Vm number update and Date of change09 January 2025Metricure® 500 mg Intrauterine Suspension
FRONTPRO chewable tablets for dogs (Great Britain)Legal category switch from POM-V to NFA-VPS as well as use in breeding female, pregnant and lactating dogs18 November 2024FRONTPRO chewable tablets for dogs (Great Britain)
FRONTPRO chewable tablets for dogs (Great Britain)Legal category switch from POM-V to NFA-VPS as well as new claim - use in breeding female, pregnant and lactating dogs18 November 2024FRONTPRO chewable tablets for dogs (Great Britain)
Eraquell Oral Paste (GB only)Change to update the local representative for Ireland for all presentations.15 November 2024Eraquell Oral Paste (GB only)
Itrafungol 10 mg/ml Oral Solution (GB)Addition of adverse event wording "sometimes fatal" in relation to a very rare transient increase in liver enzymes, "In very rare cases elevated total bilirubin may occur" and "In very rare cases weight loss may occur." Addition of "commonly" in relation to events "Salivation, vomiting, diarrhoea, anorexia, depression and apathy" on product leaflet.26 November 2024Itrafungol 10 mg/ml Oral Solution (GB)
Itrafungol 10 mg/ml Oral Solution (GB)Addition of adverse event wording "sometimes fatal" in relation to a very rare transient increase in liver enzymes, "In very rare cases elevated total bilirubin may occur" and "In very rare cases weight loss may occur." Addition of "commonly" in relation to events "Salivation, vomiting, diarrhoea, anorexia, depression and apathy" on product leaflet.26 November 2024Itrafungol 10 mg/ml Oral Solution (GB)
Itrafungol 10 mg/ml Oral Solution (GB)Addition of adverse event wording "sometimes fatal" in relation to a very rare transient increase in liver enzymes, "In very rare cases elevated total bilirubin may occur" and "In very rare cases weight loss may occur." Addition of "commonly" in relation to events "Salivation, vomiting, diarrhoea, anorexia, depression and apathy" on product leaflet.26 November 2024Itrafungol 10 mg/ml Oral Solution (GB)
HALOCUR® 0.5 mg/ml oral solution for calvesChanges to Qualitative and quantitative composition, Pharmaceutical form, Clinical particulars, Pharmaceutical particulars, Revision of the text17 October 2024HALOCUR® 0.5 mg/ml oral solution for calves
Prednidale TabletsSafety Update to SPC/PIL after PSUR Report affecting 4.5 4.6 & 4.818 June 2024Prednidale Tablets
Prednidale TabletsPrednidale 25 mg tablets Safety Update to SPC/PIL after PSUR Report affecting 4.5 4.6 & 4.818 June 2024Prednidale Tablets
Prednidale TabletsPrednidale 25 mg tablets Safety Update to SPC/PIL after PSUR Report affecting 4.5 4.6 & 4.818 June 2024Prednidale Tablets
Prednidale TabletsPrednidale 25 mg tablets - Safety Update to SPC/PIL after PSUR Report Re: 4.5 4.6 & 4.818 June 2024Prednidale Tablets
Prednidale TabletsPrednidale 25 mg tablets - Safety Update to SPC/PIL after PSUR Report Re: 4.5 4.6 & 4.818 June 2024Prednidale Tablets
Flubenol 5 % w/w Oral Powder for PigsRemoval of Titanium Dioxide from excipients10 September 2024Flubenol 5 % w/w Oral Powder for Pigs
Flubenvet 5 % w/w Premix for Medicated Feeding StuffRemoval of Titanium Dioxide from excipients10 September 2024Flubenvet 5 % w/w Premix for Medicated Feeding Stuff
Flubenol 5 % w/w Premix for Medicated Feeding StuffRemoval of Titanium Dioxide from excipients10 September 2024Flubenol 5 % w/w Premix for Medicated Feeding Stuff
Bravecto® Chewable tablets for dogsChanges/updates to Disposal advise06 September 2024Bravecto® Chewable tablets for dogs
DIVENCE IBR MARKER LIVE lyophilisate and solvent for emulsion for injection (NI Only)New Data Sheet06 September 2024DIVENCE IBR MARKER LIVE lyophilisate and solvent for emulsion for injection (NI Only)
Bovilis Cryptium® emulsion for injection for cattle (NI)Change to disposal advice05 September 2024Bovilis Cryptium® emulsion for injection for cattle (NI)
Vetflurane 1000mg/g inhalation vapour, liquid isoflurane (NI Only)One-off alignment of the product information with version 9.0.27 June 2024Vetflurane 1000mg/g inhalation vapour, liquid isoflurane (NI Only)
DIVENCE PENTA lyophilisate and solvent for emulsion for injection (NI Only)New Datasheet27 August 2024DIVENCE PENTA lyophilisate and solvent for emulsion for injection (NI Only)
Coxevac® suspension for injection for Cattle, Goats and Sheep (NI)New entry for Northern Ireland23 July 2024Coxevac® suspension for injection for Cattle, Goats and Sheep (NI)
Coxevac® suspension for injection for Cattle, Goats and Sheep (GB)Addition of sheep species23 July 2024Coxevac® suspension for injection for Cattle, Goats and Sheep (GB)
Coxevac® suspension for injection for Cattle, Goats and Sheep (GB)Addition of sheep species23 July 2024Coxevac® suspension for injection for Cattle, Goats and Sheep (GB)
Vetflurane 1000mg/g inhalation vapour, liquid isoflurane (NI Only)One-off alignment of the product information with version 9.027 June 2024Vetflurane 1000mg/g inhalation vapour, liquid isoflurane (NI Only)
Suiseng Coli / C (SPC version for GB)Add mixability licence with Susieng Diff/A17 July 2024Suiseng Coli / C (SPC version for GB)
Panacur® AquaSol 200 mg/ml oral suspension for use in drinking water for pigs and chickensChanges to contraindications, special warnings, amounts to be administered, excipients, disposal17 July 2024Panacur® AquaSol 200 mg/ml oral suspension for use in drinking water for pigs and chickens
Suiseng Coli / C (SPC version for GB)Creation of GB specific version15 July 2024Suiseng Coli / C (SPC version for GB)
Suiseng Coli / C (SPC version for Northern Ireland)Creation of an SPC version for GB as it diverged significantly from the Northern Irish version.15 July 2024Suiseng Coli / C (SPC version for Northern Ireland)
Suiseng Coli / C (SPC version for Northern Ireland)Extension of shelf-life, just for Northern Ireland15 July 2024Suiseng Coli / C (SPC version for Northern Ireland)
Suiseng Coli / C (SPC version for Northern Ireland)Extension of shelf-life, just for Northern Ireland15 July 2024Suiseng Coli / C (SPC version for Northern Ireland)
Suiseng Coli / C (SPC version for Northern Ireland)Extension of shelf-life, just for Northern Ireland15 July 2024Suiseng Coli / C (SPC version for Northern Ireland)
Suiseng Coli / C (SPC version for Northern Ireland)Extension of shelf-life, just for Northern Ireland15 July 2024Suiseng Coli / C (SPC version for Northern Ireland)
Suiseng Coli / C (SPC version for Northern Ireland)Extension of shelf-life, just for Northern Ireland15 July 2024Suiseng Coli / C (SPC version for Northern Ireland)
Suiseng Coli / C (SPC version for Northern Ireland)Extension of shelf-life, just for Northern Ireland. Extension to 24 months.15 July 2024Suiseng Coli / C (SPC version for Northern Ireland)
Fortekor Flavour tablets for cats and dogsChanges to Adverse reactions (frequency and seriousness)12 July 2024Fortekor Flavour tablets for cats and dogs
Fortekor 2.5 mg tablets for cats and dogsUpdate to Adverse reactions (frequency and seriousness)12 July 2024Fortekor 2.5 mg tablets for cats and dogs
Bovilis® INtranasal RSP™ Live nasal spray, lyophilisate and solvent for suspension for cattleChanges to pharmaceutical form, indications for use, adverse events, interactions, amounts to be administered, pack sizes and date of revision of the text.11 July 2024Bovilis® INtranasal RSP™ Live nasal spray, lyophilisate and solvent for suspension for cattle
Nobilis® E Coli Inac emulsion for injection for chickensChanges/updates to Indications for use, adverse reactions, administration routes and dosage, date of revision of the text05 July 2024Nobilis® E Coli Inac emulsion for injection for chickens
Innovax®-ILT-IBD concentrate and solvent for suspension for injection for chickensCreated new SPC datasheet05 July 2024Innovax®-ILT-IBD concentrate and solvent for suspension for injection for chickens
Bovilis® BVD Suspension for Injection for CattleChanges and/or updates to Qualitative and quantitative composition, Pharmaceutical form, Operator warnings, Adverse reactions, Interactions, Overdose, Immunological properties, Pack sizes, Disposal, Marketing authorisation number, Date of revision of the text.04 July 2024Bovilis® BVD Suspension for Injection for Cattle
Bovilis® Bovivac® SChanges and updates to Qualitative and quantitative composition, Pharmaceutical particulars, Clinical particulars, Marketing authorisation numbers20 June 2024Bovilis® Bovivac® S
Bovilis® Bovivac® SChanges and updates to Qualitative and quantitative composition, Clinical particulars, Pharmaceutical particulars, Marketing authorisation number,20 June 2024Bovilis® Bovivac® S
Bovilis® Bovivac® SChanges and updates to Qualitative and quantitative composition, Clinical particulars, Pharmaceutical particulars, Marketing authorisation numbers20 June 2024Bovilis® Bovivac® S
Bovilis® Bovivac® SChanges to Qualitative and quantitative composition, Pharmaceutical form, Clinical particulars, Pharmaceutical particulars20 June 2024Bovilis® Bovivac® S
Bravoxin® suspension for injection for cattle and sheepRemoval of text from Pharmaceutical Form. Updates to: Onset and Duration of Immunity, Adverse Reactions, Packaging, Disposal, MA numbers and Date of Revision of the Text14 June 2024Bravoxin® suspension for injection for cattle and sheep
Porcilis PCV Emulsion for injection for pigsUpdates to Warnings, Adverse reactions, Excipients, Immediate packaging11 June 2024Porcilis PCV Emulsion for injection for pigs
Bravoxin® suspension for injection for cattle and sheepRemoval of text from Pharmaceutical Form. Updates to: Onset and Duration of Immunity, Adverse Reactions, Packaging, Disposal, MA numbers and Date of Revision of the Text10 June 2024Bravoxin® suspension for injection for cattle and sheep
Bravoxin® suspension for injection for cattle and sheepRemoval of text from Pharmaceutical form. Updates to: Onset and Duration of Immunity, Adverse Reactions, Packaging, Disposal, MA numbers and Date of Revision of the Text07 June 2024Bravoxin® suspension for injection for cattle and sheep
Bravoxin® suspension for injection for cattle and sheepRemoval of text under Pharmaceutical form. Updates to Onset and Duration of Immunity. Added Adverse Reactions to a table. Updates to Immediate Packaging, MA numbers and revision of text07 June 2024Bravoxin® suspension for injection for cattle and sheep
Footvax®Changes to Qualitative and quiantitative composition, Amounts to be administered and administration route, Date of revision of the text27 May 2024Footvax®
Equimax Oral Gel for Horses (NI only)One-off alignment of the product information with version 9.0 of the QRD templates.05 May 2024Equimax Oral Gel for Horses (NI only)
New datasheet22 May 2024
Heptavac® P Plus suspension for injection for sheepChanges to Qualitative and quantitative composition, Pharmaceutical form, Clinical particulars, adverse reactions, shelf life, disposal, MA number22 May 2024Heptavac® P Plus suspension for injection for sheep
Nuflor® Minidose 450 mg/ml solution for injection for cattleUpdates to Qualitative and Quantitative Composition, Operator Warnings, Adverse Events, Use during Pregnancy and Lactation, Amounts to be administered, withdrawal period, Immediate packaging, Disposal and MA numbers21 May 2024Nuflor® Minidose 450 mg/ml solution for injection for cattle
Hyogen® emulsion for injection for pigsShelf life extension and updated layout of text throughout.09 May 2024Hyogen® emulsion for injection for pigs
NexGard Combo spot-on solution for cats <2.5 kg and NexGard Combo spot-on solution for cats 2.5-7.5 kg - Great Britain onlyUpdate to 4. CLINICAL PARTICULARS section regarding consecutive use of the products beyond 6 months07 May 2024NexGard Combo spot-on solution for cats <2.5 kg and NexGard Combo spot-on solution for cats 2.5-7.5 kg - Great Britain only
Porcilis® PCV M Hyo emulsion for injection for pigsUpdates to Averse reactions, Interactions, List of excipients, Disposal07 May 2024Porcilis® PCV M Hyo emulsion for injection for pigs
Product nameChange detailChange dateDatasheet