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
NASYM lyophilisate and solvent for suspension for injection or nasal spray for cattleShelf life increased from 15 to 24 months07 May 2020NASYM lyophilisate and solvent for suspension for injection or nasal spray for cattle
Eravac emulsion for injection for rabbitsDuration of Immunity extended from 9 to 12 months07 May 2020Eravac emulsion for injection for rabbits
Alamycin LA 200 mg/ml Solution for Injection for Cattle, Sheep and PigsList of Excipients27 May 2020Alamycin LA 200 mg/ml Solution for Injection for Cattle, Sheep and Pigs
Metacam 20 mg/ml solution for injection for cattle, pigs and horsesAdverse Events + Special Precautions to be Taken by the Person Administering the Veterinary Medicinal Product to Animals updated.08 June 2020Metacam 20 mg/ml solution for injection for cattle, pigs and horses
Metacam 40 mg/ml solution for injection for cattle and horsesAdverse Events section + Special Precautions to be Taken by the Person Administering the Veterinary Medicinal Product to Animals updated.08 June 2020Metacam 40 mg/ml solution for injection for cattle and horses
AVINEW NEO effervescent tablet for chickens and turkeysAdd new species - turkeys18 August 2020AVINEW NEO effervescent tablet for chickens and turkeys
Aivlosin 625 mg/g Granules for Use in Drinking Water for PigsUpdated withdrawal period: Pig - meat: Meat and offal: 2 days20 August 2020Aivlosin 625 mg/g Granules for Use in Drinking Water for Pigs
Aivlosin 625 mg/g Granules for Use in Drinking Water for PigsAdditional indication: Treatment and metaphylaxis of Swine Enzootic Pneumonia caused by susceptible strains of Mycoplasma hyopneumoniae.20 August 2020Aivlosin 625 mg/g Granules for Use in Drinking Water for Pigs
Aivlosin 625 mg/g Granules for Use in Drinking Water for PigsDosage for the additional indication: Swine Enzootic Pneumonia caused by susceptible strains of Mycoplasma hyopneumoniae.20 August 2020Aivlosin 625 mg/g Granules for Use in Drinking Water for Pigs
Osurnia® Ear Gel for DogsNew Product17 September 2020Osurnia® Ear Gel for Dogs
Zycortal® 25 mg/ml Prolonged-release Suspension for Injection for DogsSafety changes to SPC during renewal - Addition of injection site pain and change of frequency of pancreas disorders17 September 2020Zycortal® 25 mg/ml Prolonged-release Suspension for Injection for Dogs
Apovomin® 3 mg/ml Solution for Injection for DogsNew Product13 October 2020Apovomin® 3 mg/ml Solution for Injection for Dogs
Avishield® IB GI-13, Lyophilisate for Oculonasal Suspension/Use in Drinking Water for ChickensNew product13 October 2020Avishield® IB GI-13, Lyophilisate for Oculonasal Suspension/Use in Drinking Water for Chickens
Avishield® IB H120, Lyophilisate for Oculonasal Suspension/Use in Drinking Water for ChickensNew product13 October 2020Avishield® IB H120, Lyophilisate for Oculonasal Suspension/Use in Drinking Water for Chickens
Avishield® ND B1, Lyophilisate for Oculonasal Suspension/Use in Drinking Water for ChickensNew product13 October 2020Avishield® ND B1, Lyophilisate for Oculonasal Suspension/Use in Drinking Water for Chickens
Bupredine Multidose® 0.3 mg/ml Solution for Injection for Dogs, Cats and HorsesNew product13 October 2020Bupredine Multidose® 0.3 mg/ml Solution for Injection for Dogs, Cats and Horses
Cefabactin® TabletsNew product13 October 2020Cefabactin® Tablets
Cosacthen® 0.25 mg/ml Solution for Injection for DogsNew product13 October 2020Cosacthen® 0.25 mg/ml Solution for Injection for Dogs
Dilaterol® 25 micrograms/ml Syrup for HorsesNew product13 October 2020Dilaterol® 25 micrograms/ml Syrup for Horses
Dormazolam® 5 mg/ml Solution for Injection for HorsesNew product13 October 2020Dormazolam® 5 mg/ml Solution for Injection for Horses
Equibactin® Vet. (333 mg/g + 67 mg/g) Oral Paste for HorsesNew product13 October 2020Equibactin® Vet. (333 mg/g + 67 mg/g) Oral Paste for Horses
Equipalazone® Original 1 g Oral PowderChange of name13 October 2020Equipalazone® Original 1 g Oral Powder
Euthasol® Vet. 400 mg/ml Solution for InjectionNew product13 October 2020Euthasol® Vet. 400 mg/ml Solution for Injection
Floxabactin® TabletsNew product13 October 2020Floxabactin® Tablets
Fungiconazol® Tablets for DogsNew product13 October 2020Fungiconazol® Tablets for Dogs
Laxatract® 667 mg/ml Syrup for Dogs and CatsNew product13 October 2020Laxatract® 667 mg/ml Syrup for Dogs and Cats
Meloxidolor® 5 mg/ml Solution for Injection for Dogs, Cats, Cattle and PigsNew product13 October 2020Meloxidolor® 5 mg/ml Solution for Injection for Dogs, Cats, Cattle and Pigs
Nerfasin® Solution for InjectionNew product13 October 2020Nerfasin® Solution for Injection
Novaquin® 15 mg/ml Oral Suspension for HorsesNew product13 October 2020Novaquin® 15 mg/ml Oral Suspension for Horses
Osurnia® Ear Gel for DogsNew product13 October 2020Osurnia® Ear Gel for Dogs
Phenoleptil® Tablets for DogsNew product13 October 2020Phenoleptil® Tablets for Dogs
Rominervin® 10 mg/ml Solution for Injection for HorsesNew product13 October 2020Rominervin® 10 mg/ml Solution for Injection for Horses
Sedadex® 0.5 mg/ml Solution for Injection for Dogs and CatsNew product13 October 2020Sedadex® 0.5 mg/ml Solution for Injection for Dogs and Cats
Torphadine® 10 mg/ml Solution for Injection for Dogs, Cats and HorsesNew product13 October 2020Torphadine® 10 mg/ml Solution for Injection for Dogs, Cats and Horses
Tranquinervin® 10 mg/ml Solution for Injection for HorsesNew product13 October 2020Tranquinervin® 10 mg/ml Solution for Injection for Horses
Betamox LA 150 mg/ml Suspension for InjectionUpdated withdrawal Periods:
Cattle:
Meat: 39 days
Milk: 4.5 days
Sheep:
Meat: 29 days
Pigs
Meat: 42 days		04 December 2020Betamox LA 150 mg/ml Suspension for Injection
Ubroseal Blue Dry Cow 2.6 g intramammary suspension for cattleIntramammary suspension changed from white to blue by addition of Indigo Carmine AL Lake E 132 excipient29 January 2021Ubroseal Blue Dry Cow 2.6 g intramammary suspension for cattle
Somulose® Solution for InjectionWithdrawal notes: Additional text 'Not to be used in animals intended for human or animal consumption due to the risk of secondary intoxication'04 February 2021Somulose® Solution for Injection
Somulose® Solution for InjectionContraindications: change to text04 February 2021Somulose® Solution for Injection
Somulose® Solution for InjectionAdverse Reactions: Additional text and frequency of adverse reactions04 February 2021Somulose® Solution for Injection
Librela® solution for injection for dogsNew Product26 February 2021Librela® solution for injection for dogs
CircoMax Myco Emulsion for injection for pigsNew Product26 February 2021CircoMax Myco Emulsion for injection for pigs
Thyforon® Flavoured Tablets for DogsSafety related updates/additions to Adverse Reactions following PSUR assessment report and as a result of comments during Repeat Use Procedure15 April 2021Thyforon® Flavoured Tablets for Dogs
Product nameChange detailChange dateDatasheet