Nuflor® Minidose 450 mg/ml solution for injection for cattle | Update to Section Indications and Date of Revision of the text | 14 February 2025 | Nuflor® Minidose 450 mg/ml solution for injection for cattle |
Panacur® Small Animal 10% Oral Suspension | Update to immediate packaging and Date of revision | 14 February 2025 | Panacur® Small Animal 10% Oral Suspension |
Stelfonta 1 mg/ml solution for injection for dogs | Addition of a new therapeutic indication or modification of an approved one. | 19 January 2025 | Stelfonta 1 mg/ml solution for injection for dogs |
Nobivac® DHPPi Lyophilisate for Suspension for Injection for Dogs | Changed MA Holder different from distributor, Vm number update and Date of change | 11 February 2025 | Nobivac® DHPPi Lyophilisate for Suspension for Injection for Dogs |
Nobivac® Parvo-C Lyophilisate for suspension for injection for dogs | Changed MA Holder different from distributor, Vm number update and Date of change | 11 February 2025 | Nobivac® Parvo-C Lyophilisate for suspension for injection for dogs |
Nobivac® Rabies Suspension for injection | Changed MA Holder different from distributor, Vm number update and Date of change | 11 February 2025 | Nobivac® Rabies Suspension for injection |
Bovilis® IBR Marker Live lyophilisate and solvent for suspension for cattle | Changed MA Holder different from distributor, Vm number update and Date of change | 07 February 2025 | Bovilis® IBR Marker Live lyophilisate and solvent for suspension for cattle |
Bovilis® Huskvac | Changed MA Holder different from distributor, Vm number update and Date of change | 07 February 2025 | Bovilis® Huskvac |
Bovilis® INtranasal RSP™ Live nasal spray, lyophilisate and solvent for suspension for cattle | Changed MA Holder different from distributor, Vm number update and Date of change | 07 February 2025 | Bovilis® INtranasal RSP™ Live nasal spray, lyophilisate and solvent for suspension for cattle |
Bovilis® BVD Suspension for Injection for Cattle | Changed MA Holder different from distributor, Vm number update and Date of change | 07 February 2025 | Bovilis® 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 2025 | Alizin 30mg/ml solution for injection (GB) |
Clomicalm Tablets for Dogs | 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 2025 | Clomicalm Tablets for Dogs |
Engemycin® Spray, 25mg/ml, cutaneous spray, suspension for cattle, sheep and pigs | Changed MA Holder different from distributor, Vm number update and Date of change | 05 February 2025 | Engemycin® Spray, 25mg/ml, cutaneous spray, suspension for cattle, sheep and pigs |
Engemycin® 10% Farm Pack Solution for injection | Changed MA Holder different from distributor, Vm number update and Date of change | 05 February 2025 | Engemycin® 10% Farm Pack Solution for injection |
Engemycin® 10% DD Solution for injection | Changed MA Holder different from distributor, Vm number update and Date of change | 05 February 2025 | Engemycin® 10% DD Solution for injection |
Heptavac® P Plus suspension for injection for sheep | Changed MA Holder different from distributor, Vm number update and Date of change | 04 February 2025 | Heptavac® P Plus suspension for injection for sheep |
Bovilis® Bovivac® S | Changed MA Holder different from distributor, Vm number update and Date of change | 04 February 2025 | Bovilis® Bovivac® S |
Vecoxan® 2.5 mg/ml Oral Suspension | Update to immediate packaging only. | 04 February 2025 | Vecoxan® 2.5 mg/ml Oral Suspension |
Felimazole® 5 mg/ml Oral Solution for Cats | New Product | 02 October 2024 | Felimazole® 5 mg/ml Oral Solution for Cats |
Cobactan® MC Intramammary suspension 75 mg Milking cow | Changed MA Holder different from distributor, Vm number update and Date of change | 31 January 2025 | Cobactan® MC Intramammary suspension 75 mg Milking cow |
Cepravin® Dry Cow 250mg Intramammary suspension | Changed MA Holder different from distributor, Vm number update and Date of change | 31 January 2025 | Cepravin® Dry Cow 250mg Intramammary suspension |
Ceporex® 180 mg/ml Suspension for injection for cattle, cats and dogs | Changed MA Holder different from distributor, Vm number update and Date of change | 31 January 2025 | Ceporex® 180 mg/ml Suspension for injection for cattle, cats and dogs |
Optimmune 2 mg/g Eye Ointment | Changed MA Holder different from distributor, Vm number update and Date of change | 28 January 2025 | Optimmune 2 mg/g Eye Ointment |
Sedaxylan® 20 mg/ml Solution for Injection for Dogs, Cats, Horses and Cattle | Legal Category updated to CD(Sch 4 Pt 1) | 15 January 2025 | Sedaxylan® 20 mg/ml Solution for Injection for Dogs, Cats, Horses and Cattle |
Nerfasin® Solution for Injection | Legal Category updated to CD(Sch 4 Pt 1) | 15 January 2025 | Nerfasin® Solution for Injection |
Porcilis® APP Suspension for injection | Complete template update. | 20 January 2025 | Porcilis® APP Suspension for injection |
Nobilis® Gumboro 228E lyophilisate for use in drinking water for chickens | Changed MA Holder different from distributor, Vm number update and Date of change | 20 January 2025 | Nobilis® 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 update | 20 January 2025 | Exzolt® 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 datasheet | 20 January 2025 | Exzolt 10 mg/ml solution for use in drinking water for chickens (NI) |
Bovilis® Bovipast® RSP suspension for injection for cattle | Complete template update with changes to most sections. | 16 January 2025 | Bovilis® Bovipast® RSP suspension for injection for cattle |
Lambivac® | Changed MA Holder different from distributor, Vm number update and Date of change | 16 January 2025 | Lambivac® |
Footvax® | Changed MA Holder different from distributor, Vm number update and Date of change | 16 January 2025 | Footvax® |
CepraShort® 300 mg Intramammary Suspension for dairy cows at drying-off | Complete template update with changes to most sections. | 15 January 2025 | CepraShort® 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 2024 | Itrafungol 10 mg/ml Oral Solution (NI) |
Porcilis® AR-T DF suspension for injection for pigs | Updates to Pharmaceutical form, Adverse reactions, Pharmaceutical particulars, MA holder, MA numbers, Date of revision | 13 January 2025 | Porcilis® AR-T DF suspension for injection for pigs |
Nobilis® Gumboro D78 lyophilisate for oculonasal suspension/use in drinking water for chickens | Changed MA Holder different from distributor, Vm number update and Date of change | 13 January 2025 | Nobilis® 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 chickens | Changed MA Holder different from distributor, Vm number update and Date of change | 13 January 2025 | Nobilis® 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 chickens | Changed MA Holder different from distributor, Vm number update and Date of change | 13 January 2025 | Nobilis® Ma5 + Clone 30 lyophilisate for oculonasal suspension/use in drinking water for chickens |
Nobilis® E Coli Inac emulsion for injection for chickens | Changed MA Holder different from distributor, Vm number update and Date of change | 13 January 2025 | Nobilis® E Coli Inac emulsion for injection for chickens |
Nobilis® RT+IBmulti+ND+EDS | Changed MA Holder different from distributor, Vm number update and Date of change | 13 January 2025 | Nobilis® RT+IBmulti+ND+EDS |
Nobilis® RT+IBmulti+G+ND | Changed MA Holder different from distributor, Vm number update and Date of change | 13 January 2025 | Nobilis® RT+IBmulti+G+ND |
Nuflor® 40 mg/g Premix for Medicated Feeding Stuff for Swine | Changes 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 text | 10 January 2025 | Nuflor® 40 mg/g Premix for Medicated Feeding Stuff for Swine |
Laurabolin® 25 mg/ml, solution for injection | Changed MA Holder different from distributor, Vm number update and Date of change | 10 January 2025 | Laurabolin® 25 mg/ml, solution for injection |
Caninsulin 40 IU/ml Suspension for Injection | Changed MA Holder different from distributor, Vm number update and Date of change | 10 January 2025 | Caninsulin 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 change | 10 January 2025 | Scalibor® 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 Injection | Changed MA Holder different from distributor, Vm number update and Date of change | 09 January 2025 | Finadyne® 50mg/ml Solution for Injection |
Panacur® Bolus, 12 g Continuous Release Intraruminal Device | Changed MA Holder different from distributor, Vm number update and Date of change | 09 January 2025 | Panacur® Bolus, 12 g Continuous Release Intraruminal Device |
Dexafort® suspension for injection | Changed MA Holder different from distributor, Vm number update and Date of change | 09 January 2025 | Dexafort® suspension for injection |
Dexadreson® 2 mg/ml solution for injection | Changed MA Holder different from distributor, Vm number update and Date of change | 09 January 2025 | Dexadreson® 2 mg/ml solution for injection |
Oxytocin-S, 10 iu/ml, solution for injection | Changed MA Holder different from distributor, Vm number update and Date of change | 09 January 2025 | Oxytocin-S, 10 iu/ml, solution for injection |
Neopen® suspension for injection | Changed MA Holder different from distributor, Vm number update and Date of change | 09 January 2025 | Neopen® suspension for injection |
Chronogest CR® 20 mg controlled release vaginal sponge for sheep | Changed MA Holder different from distributor, Vm number update and Date of change | 09 January 2025 | Chronogest CR® 20 mg controlled release vaginal sponge for sheep |
Resflor® 300/16.5 mg/ml Solution for Injection for Cattle | Changed MA Holder different from distributor, Vm number update and Date of change | 09 January 2025 | Resflor® 300/16.5 mg/ml Solution for Injection for Cattle |
Metricure® 500 mg Intrauterine Suspension | Changed MA Holder different from distributor, Vm number update and Date of change | 09 January 2025 | Metricure® 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 dogs | 18 November 2024 | FRONTPRO 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 dogs | 18 November 2024 | FRONTPRO chewable tablets for dogs (Great Britain) |
Eraquell Oral Paste (GB only) | Change to update the local representative for Ireland for all presentations. | 15 November 2024 | Eraquell 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 2024 | Itrafungol 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 2024 | Itrafungol 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 2024 | Itrafungol 10 mg/ml Oral Solution (GB) |
HALOCUR® 0.5 mg/ml oral solution for calves | Changes to Qualitative and quantitative composition, Pharmaceutical form, Clinical particulars, Pharmaceutical particulars, Revision of the text | 17 October 2024 | HALOCUR® 0.5 mg/ml oral solution for calves |
Prednidale Tablets | Safety Update to SPC/PIL after PSUR Report affecting 4.5 4.6 & 4.8 | 18 June 2024 | Prednidale Tablets |
Prednidale Tablets | Prednidale 25 mg tablets Safety Update to SPC/PIL after PSUR Report affecting 4.5 4.6 & 4.8 | 18 June 2024 | Prednidale Tablets |
Prednidale Tablets | Prednidale 25 mg tablets Safety Update to SPC/PIL after PSUR Report affecting 4.5 4.6 & 4.8 | 18 June 2024 | Prednidale Tablets |
Prednidale Tablets | Prednidale 25 mg tablets - Safety Update to SPC/PIL after PSUR Report Re: 4.5 4.6 & 4.8 | 18 June 2024 | Prednidale Tablets |
Prednidale Tablets | Prednidale 25 mg tablets - Safety Update to SPC/PIL after PSUR Report Re: 4.5 4.6 & 4.8 | 18 June 2024 | Prednidale Tablets |
Flubenol 5 % w/w Oral Powder for Pigs | Removal of Titanium Dioxide from excipients | 10 September 2024 | Flubenol 5 % w/w Oral Powder for Pigs |
Flubenvet 5 % w/w Premix for Medicated Feeding Stuff | Removal of Titanium Dioxide from excipients | 10 September 2024 | Flubenvet 5 % w/w Premix for Medicated Feeding Stuff |
Flubenol 5 % w/w Premix for Medicated Feeding Stuff | Removal of Titanium Dioxide from excipients | 10 September 2024 | Flubenol 5 % w/w Premix for Medicated Feeding Stuff |
Bravecto® Chewable tablets for dogs | Changes/updates to Disposal advise | 06 September 2024 | Bravecto® Chewable tablets for dogs |
DIVENCE IBR MARKER LIVE lyophilisate and solvent for emulsion for injection (NI Only) | New Data Sheet | 06 September 2024 | DIVENCE IBR MARKER LIVE lyophilisate and solvent for emulsion for injection (NI Only) |
Bovilis Cryptium® emulsion for injection for cattle (NI) | Change to disposal advice | 05 September 2024 | Bovilis 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 2024 | Vetflurane 1000mg/g inhalation vapour, liquid isoflurane (NI Only) |
DIVENCE PENTA lyophilisate and solvent for emulsion for injection (NI Only) | New Datasheet | 27 August 2024 | DIVENCE PENTA lyophilisate and solvent for emulsion for injection (NI Only) |
Coxevac® suspension for injection for Cattle, Goats and Sheep (NI) | New entry for Northern Ireland | 23 July 2024 | Coxevac® suspension for injection for Cattle, Goats and Sheep (NI) |
Coxevac® suspension for injection for Cattle, Goats and Sheep (GB) | Addition of sheep species | 23 July 2024 | Coxevac® suspension for injection for Cattle, Goats and Sheep (GB) |
Coxevac® suspension for injection for Cattle, Goats and Sheep (GB) | Addition of sheep species | 23 July 2024 | Coxevac® 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 9.0 | 27 June 2024 | Vetflurane 1000mg/g inhalation vapour, liquid isoflurane (NI Only) |
Suiseng Coli / C (SPC version for GB) | Add mixability licence with Susieng Diff/A | 17 July 2024 | Suiseng Coli / C (SPC version for GB) |
Panacur® AquaSol 200 mg/ml oral suspension for use in drinking water for pigs and chickens | Changes to contraindications, special warnings, amounts to be administered, excipients, disposal | 17 July 2024 | Panacur® 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 version | 15 July 2024 | Suiseng 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 2024 | Suiseng Coli / C (SPC version for Northern Ireland) |
Suiseng Coli / C (SPC version for Northern Ireland) | Extension of shelf-life, just for Northern Ireland | 15 July 2024 | Suiseng Coli / C (SPC version for Northern Ireland) |
Suiseng Coli / C (SPC version for Northern Ireland) | Extension of shelf-life, just for Northern Ireland | 15 July 2024 | Suiseng Coli / C (SPC version for Northern Ireland) |
Suiseng Coli / C (SPC version for Northern Ireland) | Extension of shelf-life, just for Northern Ireland | 15 July 2024 | Suiseng Coli / C (SPC version for Northern Ireland) |
Suiseng Coli / C (SPC version for Northern Ireland) | Extension of shelf-life, just for Northern Ireland | 15 July 2024 | Suiseng Coli / C (SPC version for Northern Ireland) |
Suiseng Coli / C (SPC version for Northern Ireland) | Extension of shelf-life, just for Northern Ireland | 15 July 2024 | Suiseng 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 2024 | Suiseng Coli / C (SPC version for Northern Ireland) |
Fortekor Flavour tablets for cats and dogs | Changes to Adverse reactions (frequency and seriousness) | 12 July 2024 | Fortekor Flavour tablets for cats and dogs |
Fortekor 2.5 mg tablets for cats and dogs | Update to Adverse reactions (frequency and seriousness) | 12 July 2024 | Fortekor 2.5 mg tablets for cats and dogs |
Bovilis® INtranasal RSP™ Live nasal spray, lyophilisate and solvent for suspension for cattle | Changes to pharmaceutical form, indications for use, adverse events, interactions, amounts to be administered, pack sizes and date of revision of the text. | 11 July 2024 | Bovilis® INtranasal RSP™ Live nasal spray, lyophilisate and solvent for suspension for cattle |
Nobilis® E Coli Inac emulsion for injection for chickens | Changes/updates to Indications for use, adverse reactions, administration routes and dosage, date of revision of the text | 05 July 2024 | Nobilis® E Coli Inac emulsion for injection for chickens |
Innovax®-ILT-IBD concentrate and solvent for suspension for injection for chickens | Created new SPC datasheet | 05 July 2024 | Innovax®-ILT-IBD concentrate and solvent for suspension for injection for chickens |
Bovilis® BVD Suspension for Injection for Cattle | Changes 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 2024 | Bovilis® BVD Suspension for Injection for Cattle |
Bovilis® Bovivac® S | Changes and updates to Qualitative and quantitative composition, Pharmaceutical particulars, Clinical particulars, Marketing authorisation numbers | 20 June 2024 | Bovilis® Bovivac® S |
Bovilis® Bovivac® S | Changes and updates to Qualitative and quantitative composition, Clinical particulars, Pharmaceutical particulars, Marketing authorisation number, | 20 June 2024 | Bovilis® Bovivac® S |
Bovilis® Bovivac® S | Changes and updates to Qualitative and quantitative composition, Clinical particulars, Pharmaceutical particulars, Marketing authorisation numbers | 20 June 2024 | Bovilis® Bovivac® S |
Bovilis® Bovivac® S | Changes to Qualitative and quantitative composition, Pharmaceutical form, Clinical particulars, Pharmaceutical particulars | 20 June 2024 | Bovilis® Bovivac® S |
Bravoxin® suspension for injection for cattle and sheep | Removal of text from Pharmaceutical Form. Updates to: Onset and Duration of Immunity, Adverse Reactions, Packaging, Disposal, MA numbers and Date of Revision of the Text | 14 June 2024 | Bravoxin® suspension for injection for cattle and sheep |
Porcilis PCV Emulsion for injection for pigs | Updates to Warnings, Adverse reactions, Excipients, Immediate packaging | 11 June 2024 | Porcilis PCV Emulsion for injection for pigs |
Bravoxin® suspension for injection for cattle and sheep | Removal of text from Pharmaceutical Form. Updates to: Onset and Duration of Immunity, Adverse Reactions, Packaging, Disposal, MA numbers and Date of Revision of the Text | 10 June 2024 | Bravoxin® suspension for injection for cattle and sheep |
Bravoxin® suspension for injection for cattle and sheep | Removal of text from Pharmaceutical form. Updates to: Onset and Duration of Immunity, Adverse Reactions, Packaging, Disposal, MA numbers and Date of Revision of the Text | 07 June 2024 | Bravoxin® suspension for injection for cattle and sheep |
Bravoxin® suspension for injection for cattle and sheep | Removal 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 text | 07 June 2024 | Bravoxin® 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 text | 27 May 2024 | Footvax® |
Equimax Oral Gel for Horses (NI only) | One-off alignment of the product information with version 9.0 of the QRD templates. | 05 May 2024 | Equimax Oral Gel for Horses (NI only) |
| New datasheet | 22 May 2024 | |
Heptavac® P Plus suspension for injection for sheep | Changes to Qualitative and quantitative composition, Pharmaceutical form, Clinical particulars, adverse reactions, shelf life, disposal, MA number | 22 May 2024 | Heptavac® P Plus suspension for injection for sheep |
Nuflor® Minidose 450 mg/ml solution for injection for cattle | Updates 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 numbers | 21 May 2024 | Nuflor® Minidose 450 mg/ml solution for injection for cattle |
Hyogen® emulsion for injection for pigs | Shelf life extension and updated layout of text throughout. | 09 May 2024 | Hyogen® 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 only | Update to 4. CLINICAL PARTICULARS section regarding consecutive use of the products beyond 6 months | 07 May 2024 | 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 only |
Porcilis® PCV M Hyo emulsion for injection for pigs | Updates to Averse reactions, Interactions, List of excipients, Disposal | 07 May 2024 | Porcilis® PCV M Hyo emulsion for injection for pigs |
Eradia 125 mg/ml oral suspension for dogs (NI Only) | To update the SPC and QRD in line with new guidance | 23 April 2024 | Eradia 125 mg/ml oral suspension for dogs (NI Only) |
Dormazolam® 5 mg/ml Solution for Injection for Horses | Change of MAH to Dechra Regulatory BV from Le Vet Beheer BV | 04 March 2024 | Dormazolam® 5 mg/ml Solution for Injection for Horses |
Cobactan® MC Intramammary suspension 75 mg Milking cow | Corrected table in Clinical particulars | 22 April 2024 | Cobactan® MC Intramammary suspension 75 mg Milking cow |
Scalibor® Protectorband 0.76 g medicated collar for small and medium dogs and Scalibor® Protectorband 1.0 g medicated collar for large dogs | Changes to operator warnings, changes to pharmacological particulars | 22 April 2024 | Scalibor® Protectorband 0.76 g medicated collar for small and medium dogs and Scalibor® Protectorband 1.0 g medicated collar for large dogs |
Scalibor® Protectorband 0.76 g medicated collar for small and medium dogs and Scalibor® Protectorband 1.0 g medicated collar for large dogs | Corrected format of Qualitative and quantitative composition, Updated Vm numbers to reflect size | 19 April 2024 | Scalibor® Protectorband 0.76 g medicated collar for small and medium dogs and Scalibor® Protectorband 1.0 g medicated collar for large dogs |
Panacur® 187.5 mg/g Oral Paste for dogs and cats | Corrected excipient amount. Included sentence under Dosing. | 18 April 2024 | Panacur® 187.5 mg/g Oral Paste for dogs and cats |
Zanil® Fluke Drench 34 mg/ml Oral Suspension | Updated date of revision of text | 17 April 2024 | Zanil® Fluke Drench 34 mg/ml Oral Suspension |
Mastiplan® LC, 300mg/20mg (Cefapirin/Prednisolone), intramammary suspension for lactating cows | Deleted sentence under adverse reactions | 17 April 2024 | Mastiplan® LC, 300mg/20mg (Cefapirin/Prednisolone), intramammary suspension for lactating cows |
Porcilis® Ery suspension for injection | Added excipient, updated date of revision | 17 April 2024 | Porcilis® Ery suspension for injection |
Panacur® Equine Oral Paste 18.75 % w/w | Corrected dosage, updated date of revision of the text | 17 April 2024 | Panacur® Equine Oral Paste 18.75 % w/w |
| Corrected storage precautions | 17 April 2024 | |
Panacur® Equine Guard 10% w/v Oral Suspension | Updated date of revision of the text. | 17 April 2024 | Panacur® Equine Guard 10% w/v Oral Suspension |
Panacur® Equine Granules 22.2% w/w | Change of date of last update | 17 April 2024 | Panacur® Equine Granules 22.2% w/w |
Cyclavance 100mg/ml oral solution for dogs and cats (NI) | One-off alignment of the product information with version 9.0 of the QRD template | 04 April 2024 | Cyclavance 100mg/ml oral solution for dogs and cats (NI) |
NEXGARD SPECTRA (all pack sizes) Great Britain only | Update in minimum bodyweight from >2.0 kg to >1.35 kg for the XS pack size (9 mg / 2 mg) | 02 April 2024 | NEXGARD SPECTRA (all pack sizes) Great Britain only |
CANIXIN DHPPi/L lyophilisate and suspension for suspension for injection for dogs (NI only) | One-off alignment of the product information with version 9.0* of the QRD templates | 19 March 2024 | CANIXIN DHPPi/L lyophilisate and suspension for suspension for injection for dogs (NI only) |
Selectan | Variation special precautions VMPs containing florfenicol | 03 April 2024 | Selectan |
Nuflor® 300 mg/ml solution for injection for cattle and sheep | Qualitative and quantitative composition, add excipient. Operator warnings. Use during pregnancy or lactation. | 25 March 2024 | Nuflor® 300 mg/ml solution for injection for cattle and sheep |
Innovax®-ND-IBD concentrate and solvent for suspension for injection for chickens | Changes to amount to be administered, preparation of the vaccine under clinical particulars. Change to shelf life, immediate packaging and disposal. | 20 March 2024 | Innovax®-ND-IBD concentrate and solvent for suspension for injection for chickens |
Allevinix® 50 mg/ml solution for injection for cattle, pigs and horses (GB) | Special precautions, environmental properties, adverse event formatting and MA numbers updated. | 19 March 2024 | Allevinix® 50 mg/ml solution for injection for cattle, pigs and horses (GB) |
Dexacortone® Chewable Tablets | New Product | 15 March 2024 | Dexacortone® Chewable Tablets |
Equilis® Prequenza Te suspension for injection for horses (NI) | New UK(NI) datasheet | 05 March 2024 | Equilis® Prequenza Te suspension for injection for horses (NI) |
Equilis® Prequenza Te suspension for injection for horses (GB) | Changes to Duration of immunity. Changes to Adverse reactions. Change to Interactions. Changes to vaccination schedule. Changes to Concurrent and passive immunity. Changes to excipients. | 05 March 2024 | Equilis® Prequenza Te suspension for injection for horses (GB) |
Rhiniseng | Changes in the SPC for Northern Ireland: list of excipients format and modification of the adverse events section plus some special warnings | 28 February 2024 | Rhiniseng |
Vepured | Update in the SPC for NI only affecting the duration of immunity (expressed as weeks) and details on adverse reactions. | 28 February 2024 | Vepured |
Porcilis® ColiClos suspension for injection for pigs | Adverse reactions section updated. Disposal advise updated. | 28 February 2024 | Porcilis® ColiClos suspension for injection for pigs |