Eqvalan Duo, oral paste - UK(NI) | Creation of separate UK(GB) and UK(NI) datasheets to reflect splitting of the UK licence | 10 June 2022 | Eqvalan Duo, oral paste - UK(NI) |
Purevax RCPCh lyophilisate and solvent for suspension for injection | Addition of emesis (mostly within 24 to 48 hours) to adverse reactions section | 06 May 2022 | Purevax RCPCh lyophilisate and solvent for suspension for injection |
Purevax RCPCh FeLV lyophilisate and solvent for suspension for injection | Addition of emesis (mostly within 24 to 48 hours) to adverse reactions section | 06 May 2022 | Purevax RCPCh FeLV lyophilisate and solvent for suspension for injection |
Purevax RCP lyophilisate and solvent for suspension for injection | Addition of emesis (mostly within 24 to 48 hours) to adverse reactions section | 06 May 2022 | Purevax RCP lyophilisate and solvent for suspension for injection |
Purevax RCP FeLV lyophilisate and solvent for suspension for injection | Addition of emesis (mostly within 24 to 48 hours) to adverse reactions section | 06 May 2022 | Purevax RCP FeLV lyophilisate and solvent for suspension for injection |
Purevax RC lyophilisate and solvent for suspension for injection | Addition of emesis (mostly within 24 to 48 hours) to adverse reactions section | 06 May 2022 | Purevax RC lyophilisate and solvent for suspension for injection |
Pen & Strep Suspension for Injection | Clinical particulars: Adverse reactions (frequency & seriousness) - text has been updated Pharmacological particulars - ATCvet Code: Updated from QJ5RC03 to QJ01RA01 | 13 April 2022 | Pen & Strep Suspension for Injection |
Buscopan Compositum Solution for Injection | Change in shelf life from 4 years to 3 years | 26 April 2022 | Buscopan Compositum Solution for Injection |
Sedivet 10 mg/ml solution for injection for horses | Change in shelf life from 5 years to 3 years | 26 April 2022 | Sedivet 10 mg/ml solution for injection for horses |
Tralieve® Chewable Tablets for Dogs | MAH Change from Le Vet Beheer BV to Dechra Regulatory BV | 07 April 2022 | Tralieve® Chewable Tablets for Dogs |
Prednicortone® 5 mg Tablets for Dogs and Cats | MAH Change from Le Vet Beheer BV to Dechra Regulatory BV | 07 April 2022 | Prednicortone® 5 mg Tablets for Dogs and Cats |
Metrobactin® Tablets for Dogs and Cats | MAH Change from Le Vet Beheer BV to Dechra Regulatory BV | 07 April 2022 | Metrobactin® Tablets for Dogs and Cats |
Denagard 200 mg/ml Solution for Injection | Withdrawal period has been decreased from 28 days to 22 days | 11 March 2022 | Denagard 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 chickens | Remove contraindication for use during lay | 17 March 2022 | Poulvac E.coli lyophilisate for suspension for spray vaccination for chickens and turkeys or for use in drinking water for chickens |
Apoquel chewable tablets for dogs | New product | 09 March 2022 | Apoquel chewable tablets for dogs |
Betamox LA 150 mg/ml Suspension for Injection | Change to Clinical Particulars - Adverse Reactions (frequency & seriousness) - see datasheet | 08 March 2022 | Betamox LA 150 mg/ml Suspension for Injection |
Respiporc® FLUpan H1N1 suspension for injection for pigs | Update regarding use in pregnancy and lactation | 01 March 2022 | Respiporc® FLUpan H1N1 suspension for injection for pigs |
Ronaxan 20mg, 100mg Tablet | Shelf life increased from 2 years to 3 years | 27 January 2022 | Ronaxan 20mg, 100mg Tablet |
Ronaxan 20mg, 100mg Tablet | Updates to pharmacodynamics/pharmacokinetics sections to reflect updated info | 27 January 2022 | Ronaxan 20mg, 100mg Tablet |
Ronaxan 20mg, 100mg Tablet | Update to interaction with other medicines section - anticoagulant therapy | 27 January 2022 | Ronaxan 20mg, 100mg Tablet |
Ronaxan 20mg, 100mg Tablet | Change in adverse reactions section | 27 January 2022 | Ronaxan 20mg, 100mg Tablet |
Ronaxan 20mg, 100mg Tablet | Addition of information on special precautions for use | 27 January 2022 | Ronaxan 20mg, 100mg Tablet |
Ronaxan 20mg, 100mg Tablet | Addition of special warnings for target species: dogs, with respect to treating Ehrlichia Canis infections | 27 January 2022 | Ronaxan 20mg, 100mg Tablet |
Ronaxan 20mg, 100mg Tablet | Addition 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 2022 | Ronaxan 20mg, 100mg Tablet |
Ronaxan 20mg, 100mg Tablet | Removal of indication to treat infections caused by Staphylococcus and Streptococcus spp in dogs | 27 January 2022 | Ronaxan 20mg, 100mg Tablet |
Ronaxan 20mg, 100mg Tablet | Addition of cats as target species (100 mg only) | 27 January 2022 | Ronaxan 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 kg | Addition of use in breeding, pregnant and lactating queens. | 22 December 2021 | NexGard 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 kg | Addition of indication: treatment of infections with L3, L4 larvae and adults of Aelurostrongylus abstrusus | 22 December 2021 | NexGard 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 kg | Addition of indication: treatment of Notoedric mange (caused by Notoedres cati). | 22 December 2021 | NexGard 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 Cattle | Addition of anaphylactic-type reactions to adverse reactions warnings | 21 December 2021 | UBAC Emulsion for Injection for Cattle |
Felpreva Spot on Solution for Cats | New Marketing Authorisation | 18 November 2021 | Felpreva Spot on Solution for Cats |
Equipalazone® 1 g Oral Powder for Horses and Ponies | New product | 08 October 2021 | Equipalazone® 1 g Oral Powder for Horses and Ponies |
Vetoryl® Hard Capsules for Dogs | Addition of 5mg strength | 08 October 2021 | Vetoryl® Hard Capsules for Dogs |
Sympagesic® 500 mg/ml + 4 mg/ml Solution for Injection for Horses, Cattle, Pigs and Dogs | New product | 08 October 2021 | Sympagesic® 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 Sheep | New product | 08 October 2021 | Rexxolide® 100 mg/ml Solution for Injection for Cattle, Pigs and Sheep |
Prevomax® 10 mg/ml Solution for Injection for Dogs and Cats | Change of NI MAH from Le Vet Beheer to Dechra Regulatory BV | 08 October 2021 | Prevomax® 10 mg/ml Solution for Injection for Dogs and Cats |
Mirataz® 20 mg/g Transdermal Ointment for Cats | New product | 08 October 2021 | Mirataz® 20 mg/g Transdermal Ointment for Cats |
Metrobactin® Tablets for Dogs and Cats | Safety related update to SPC | 08 October 2021 | Metrobactin® Tablets for Dogs and Cats |
Equisolon® Oral Powder for Horses | New product | 08 October 2021 | Equisolon® Oral Powder for Horses |
Equibactin® 250 mg/g + 50 mg/g Oral Powder for Horses | New product | 08 October 2021 | Equibactin® 250 mg/g + 50 mg/g Oral Powder for Horses |
Avishield® ND, Lyophilisate for Oculonasal Suspension/Use in Drinking Water for Chickens and Turkeys | Minor change to name and updated text | 08 October 2021 | Avishield® ND, Lyophilisate for Oculonasal Suspension/Use in Drinking Water for Chickens and Turkeys |
Avishield® IBD Plus Lyophilisate for Use in Drinking Water for Chickens | New product | 08 October 2021 | Avishield® 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 Category | 29 September 2021 | FIPROtec® Spray 2.5 mg/ml Cutaneous Spray, Solution for Cats and Dogs (GB) |
Canishield® Medicated Collar for Dogs (GB) | Legal Category | 29 September 2021 | Canishield® Medicated Collar for Dogs (GB) |
Arti-Cell Forte suspension for injection for horses | Change in Marketing Authoristion Holder | 07 July 2021 | Arti-Cell Forte suspension for injection for horses |
Mepidor 20mg/ml Injection | At the time of renewal there has been a change in the wording of Section 4.7 to include additional information | 21 September 2021 | Mepidor 20mg/ml Injection |
PROGRAM Plus film-coated tablets 23mg/460 mg | Reduction in shelf life from 5 to 3 years | 16 September 2021 | PROGRAM Plus film-coated tablets 23mg/460 mg |
PROGRAM Plus film-coated tablets 11.5mg/230 mg | Reduction in shelf life from 5 to 3 years | 16 September 2021 | PROGRAM Plus film-coated tablets 11.5mg/230 mg |
PROGRAM Plus film-coated tablets 5.75mg/115 mg | Reduction in shelf life from 5 to 3 years | 16 September 2021 | PROGRAM Plus film-coated tablets 5.75mg/115 mg |
PROGRAM Plus film-coated tablets 2.3mg/46 mg | Reduction in shelf life from 5 to 3 years | 16 September 2021 | PROGRAM Plus film-coated tablets 2.3mg/46 mg |
Thyronorm 5 mg/ml Oral Solution for Cats | Clinical Particulars/Adverse reactions (frequency & seriousness): additional paragraph added | 14 September 2021 | Thyronorm 5 mg/ml Oral Solution for Cats |
Thyronorm 5 mg/ml Oral Solution for Cats | Clinical 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 2021 | Thyronorm 5 mg/ml Oral Solution for Cats |
Noropraz, 18.7 mg/g + 140.3 mg/g Oral Paste for Horses | Clinical Particulars/Adverse reactions (frequency & seriousness) - additional paragraph added | 14 September 2021 | Noropraz, 18.7 mg/g + 140.3 mg/g Oral Paste for Horses |
Noromectin 1.87% Oral Paste for Horses | Pharmaceutical particulars/List of Excipient(s) - added Water for injection | 14 September 2021 | Noromectin 1.87% Oral Paste for Horses |
Norocillin 30% w/v Suspension for Injection | Clinical Particulars/Adverse reactions (frequency & seriousness) additional paragraph added | 14 September 2021 | Norocillin 30% w/v Suspension for Injection |
Loxicom 5 mg/ml Solution for Injection for Dogs and Cats | Clinical Particulars/Adverse Reactions (frequency & seriousness) - additional line "In very rare cases elevated liver enzymes have been reported". | 14 September 2021 | Loxicom 5 mg/ml Solution for Injection for Dogs and Cats |
Loxicom 20 mg/ml Solution for Injection for Cattle, Pigs and Horses | Additional paragraph, "Withdrawal period(s)" added to Clinical Particulars section | 14 September 2021 | Loxicom 20 mg/ml Solution for Injection for Cattle, Pigs and Horses |
Combiclav Lactating Cow Intramammary Suspension | Withdrawal notes updated | 14 September 2021 | Combiclav Lactating Cow Intramammary Suspension |
Bovalto Respi Intranasal | Addition of a 10-dose presentation. | 03 September 2021 | Bovalto Respi Intranasal |
Eprinex Multi 5 mg/ml pour-on solution for cattle, sheep and goats | Renewal (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 2021 | Eprinex Multi 5 mg/ml pour-on solution for cattle, sheep and goats |
Lydaxx 100 mg/ml solution for injection for cattle, pigs and sheep | Alignment of the product information to the product information of the reference product | 01 July 2021 | Lydaxx 100 mg/ml solution for injection for cattle, pigs and sheep |
Solantel 200mg/ml Pour-On Solution for Cattle | New Product | 23 August 2021 | Solantel 200mg/ml Pour-On Solution for Cattle |
Daxocox tablets for dogs | New Product | 13 July 2021 | Daxocox 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 dogs | Name Changes for Kesium range - product names changed throughout SPC | 07 July 2021 | Kesium® 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 cats | New Datasheet | 07 July 2021 | Versifel® FeLV suspension for injection for cats |
Vetbromide 600mg tablets for dogs | NEW PRODUCT | 05 July 2021 | Vetbromide 600mg tablets for dogs |
Rispoval 2 / BRSV + Pi3 Lyophilisate and solvent for suspension for injection for cattle | New Product | 01 July 2021 | Rispoval 2 / BRSV + Pi3 Lyophilisate and solvent for suspension for injection for cattle |
Pracetam® 400 mg/ml solution for use in drinking water for pigs | Updated text throughout Clinical particulars including; special precautions for use, adverse reactions, use during pregnancy and lactation, amounts to be administered and overdose. | 28 June 2021 | Pracetam® 400 mg/ml solution for use in drinking water for pigs |
Emeprid® 5 mg/ml solution for injection for dogs and cats | Adverse Reactions- text updated | 28 June 2021 | Emeprid® 5 mg/ml solution for injection for dogs and cats |