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 |
Panacur® Equine Guard with Apple and Cinnamon Flavour 10% w/v Oral Suspension | Corrected storage precautions | 17 April 2024 | Panacur® Equine Guard with Apple and Cinnamon Flavour 10% w/v Oral Suspension |
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) |
Neptra ear drops solution for dogs | Special precautions for use: Use in cats should be avoided. | 31 August 2023 | Neptra ear drops solution for dogs |
NEXGARD SPECTRA (all pack sizes) Northern Ireland only | Change of the minimum bodyweight of the XS pack size (9mg/2 mg) from 2.0 kg to 1.35 kg | 24 October 2023 | NEXGARD SPECTRA (all pack sizes) Northern Ireland only |
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 | 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 |
Pergocoat Film-coated Tablets for Horses | New Product | 29 January 2024 | Pergocoat Film-coated Tablets for Horses |
Zenalpha® 0.5 mg/ml + 10 mg/ml Solution for Injection for Dogs | New Product | 25 January 2024 | Zenalpha® 0.5 mg/ml + 10 mg/ml Solution for Injection for Dogs |
Cyclofin® 300 mg/ml + 20 mg/ml Solution for Injection for Cattle | New Product | 16 January 2024 | Cyclofin® 300 mg/ml + 20 mg/ml Solution for Injection for Cattle |
Dexacortone® Chewable Tablets | New Product | 15 March 2024 | Dexacortone® Chewable Tablets |
Equilis® Prequenza Te suspension for injection for horses - (UK(NI)) | New UK(NI) datasheet | 05 March 2024 | Equilis® Prequenza Te suspension for injection for horses - (UK(NI)) |
Equilis® Prequenza Te suspension for injection for horses - (UK(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 - (UK(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 |
Noroseal 2.6g Intramammary Suspension for Cattle | Clinical Particulars/Adverse reactions (frequency and seriousness) - Updated | 09 February 2024 | Noroseal 2.6g Intramammary Suspension for Cattle |
Noroseal 2.6g Intramammary Suspension for Cattle | Clinical Particulars/Special precautions for use in animals - Change to existing wording | 09 February 2024 | Noroseal 2.6g Intramammary Suspension for Cattle |
Chronogest CR® 20 mg controlled release vaginal sponge for sheep | Active substance update. Pharmaceutical form. Operator warnings. Adverse events. Withdrawal period. Pharmacodynamic properties. Pharmaceutical particulars. Shelf-life. Disposal. MA numbers. | 09 February 2024 | Chronogest CR® 20 mg controlled release vaginal sponge for sheep |
ERYSENG suspension for injection for pigs | Format change and reconciliation of GB and NI versions. | 07 February 2024 | ERYSENG suspension for injection for pigs |
ERYSENG PARVO suspension for injection for pigs (version only for Northern Ireland) | Creation of a new version just for NI: major changes in the "Clinical information" section, specially "Adverse events". Also in the "Immunological information", "special precautions". List of excipients are moved to the "composition" section. | 07 February 2024 | ERYSENG PARVO suspension for injection for pigs (version only for Northern Ireland) |
ERYSENG suspension for injection for pigs | Creation of different version for GB and NI | 07 February 2024 | ERYSENG suspension for injection for pigs |
ERYSENG PARVO suspension for injection for pigs (version only for GB) | Creation of different version for GB and NI | 07 February 2024 | ERYSENG PARVO suspension for injection for pigs (version only for GB) |
Equilis® Te suspension for injection for horses | Changes to indications for use, adverse reactions, interactions, disposal and changes to MA number | 07 February 2024 | Equilis® Te suspension for injection for horses |
Equilis® Prequenza suspension for injection for horses | Changes to Adverse Reactions, Change to duration of immunity | 06 February 2024 | Equilis® Prequenza suspension for injection for horses |
M+PAC® | Change to marketing authorisation number | 06 February 2024 | M+PAC® |
Bovigen Scour Emulsion for injection for cattle | Extension of in-use shelf life from 10 hours to 10 days. | 16 October 2023 | Bovigen Scour Emulsion for injection for cattle |
Porcilis® Lawsonia ID lyophilisate and solvent for emulsion for injection for pigs | Changes to operator warnings, adverse reactions, interactions, pharmacological particulars and marketing authorisation number. | 26 January 2024 | Porcilis® Lawsonia ID lyophilisate and solvent for emulsion for injection for pigs |
Thyronorm 5 mg/ml Oral Solution for Cats | Clinical Particulars / Amounts to be administered and administration route - Updated | 22 January 2024 | Thyronorm 5 mg/ml Oral Solution for Cats |
Eravac emulsion for injection for rabbits | Update of additional excipient information for Northern Ireland | 22 January 2024 | Eravac emulsion for injection for rabbits |
Zuprevo® 180 mg/ml solution for injection for cattle | Changes to pharmaceutical form, indications for use, contraindications, special warnings for each target species, special precautions for use, operator warnings, adverse reactions, use during pregnancy, interactions, withdrawal periods, pharmacodynamic properties, immediate packaging and disposal | 15 January 2024 | Zuprevo® 180 mg/ml solution for injection for cattle |
UBAC Emulsion for Injection for Cattle | Addition of Excipients for Northern Ireland | 15 January 2024 | UBAC Emulsion for Injection for Cattle |
Panacur® Rabbit 18.7.5 mg/g Oral Paste | Changes to product name, presentation and package quantities | 08 January 2024 | Panacur® Rabbit 18.7.5 mg/g Oral Paste |
Cephaguard DC 150 mg intramammary ointment (NI) | Update to the latest version of the EU QRD template | 02 November 2023 | Cephaguard DC 150 mg intramammary ointment (NI) |
Bovilis® Rotavec® Corona Emulsion for Injection for Cattle. | Changes made to Marketing Authorisation number | 04 January 2024 | Bovilis® Rotavec® Corona Emulsion for Injection for Cattle. |
AviPro AE Suspension for use in drinking water for chicken | New Product | 22 December 2023 | AviPro AE Suspension for use in drinking water for chicken |
Suiseng Diff/A (SPC version only for Northern Ireland) | Version for only for Northern Ireland | 19 December 2023 | Suiseng Diff/A (SPC version only for Northern Ireland) |
Suiseng Diff/A (SPC Version for GB) | This datasheet version only applies for GB | 19 December 2023 | Suiseng Diff/A (SPC Version for GB) |
Gudair emulsion for injection for sheep and goats | Change in the name and address of the marketing authorisation holder. | 05 December 2023 | Gudair emulsion for injection for sheep and goats |
Gudair emulsion for injection for sheep and goats | Changes to Sections 4.4 and 4.5 to add: 'Gudair vaccine should be exclusively administered subcutaneously using a 6 mm (18 Gauge) needle on a 45º degree angle on the side of the neck midway between the ear and the front of the shoulder. Do not inject at any other site.' | 03 August 2023 | Gudair emulsion for injection for sheep and goats |
Stelfonta 1 mg/ml solution for injection for dogs | Change(s) in the SPC, labelling or package leaflet intended to implement the outcome of a procedure or recommendations from the competent authority- Including recommended wording as requested following review of a PSUR. One-off alignment of the product information with version 9.0* of the QRD template. | 30 August 2023 | Stelfonta 1 mg/ml solution for injection for dogs |
Norodine 24 Solution for Injection | Clinical Particulars/Use during pregnancy, lactation or lay - Updated | 28 November 2023 | Norodine 24 Solution for Injection |
Norodine 24 Solution for Injection | Clinical Particulars/Special precautions for use/Special precautions to be taken by the person administering the veterinary medicinal product to animals - Updated | 28 November 2023 | Norodine 24 Solution for Injection |
Norodine 24 Solution for Injection | Qualitative And Quantitative Composition - Updated Excipients | 28 November 2023 | Norodine 24 Solution for Injection |
Vectra® 3D spot-on solution for dogs | Changes in relation to N-methyl pyrrolidone. Changes to sections; Special precautions for people administering the mediation and Use during pregnancy lactation or lay. The veterinary medicinal product should not be administered by pregnant women and women suspected of being pregnant.
Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product by women of childbearing age. | 27 November 2023 | Vectra® 3D spot-on solution for dogs |
Purevax Rabies suspension for injection (GB) | Reformatting of SPC text to new format (QRD v9) | 27 October 2023 | Purevax Rabies suspension for injection (GB) |
Eprecis® 20 mg/ml solution for injection for cattle, sheep and goats (GB) | New indication for sheep and goats. GB / NI SPCs separated | 22 November 2023 | Eprecis® 20 mg/ml solution for injection for cattle, sheep and goats (GB) |
Eprecis® 20 mg/ml solution for injection for cattle, sheep and goats (NI) | New indication for sheep and goats. GB / NI SPCs separated | 22 November 2023 | Eprecis® 20 mg/ml solution for injection for cattle, sheep and goats (NI) |
Caninsulin 40 IU/ml Suspension for Injection | Changes to qualitative and quantitative composition, preservative, pharmacokinetic particulars and pharmaceutical particulars. | 14 November 2023 | Caninsulin 40 IU/ml Suspension for Injection |
Suiseng Coli / C | Major overhaul of the SPC including different sections. | 13 November 2023 | Suiseng Coli / C |
Bovilis® IBR Marker Inac suspension for injection for cattle | Change to MA number | 06 November 2023 | Bovilis® IBR Marker Inac suspension for injection for cattle |
Resflor® 300/16.5 mg/ml Solution for Injection for Cattle | Changes to qualitative and quantitative composition, pharmaceutical form, special precautions for use, operator warnings, adverse reactions, use during pregnancy or lactation, amounts to be administered, withdrawal periods, pharmacological particulars, pharmaceutical particulars and MA number. | 06 November 2023 | Resflor® 300/16.5 mg/ml Solution for Injection for Cattle |
Nobilis® Ma5 + Clone 30 lyophilisate for oculonasal suspension/use in drinking water for chickens. | Changes to active substances. | 31 October 2023 | Nobilis® Ma5 + Clone 30 lyophilisate for oculonasal suspension/use in drinking water for chickens. |
Marbocyl P 5mg, 20mg and 80mg Tablets | Addition of new adverse events following PSUR review | 30 October 2023 | Marbocyl P 5mg, 20mg and 80mg Tablets |
Marbocyl™ 10% Solution for Injection | Addition of adverse events following PSUR review | 30 October 2023 | Marbocyl™ 10% Solution for Injection |
Marbocyl™ SA 200mg Powder and Solvent for Solution for Injection | Addition of new adverse events following PSUR review | 30 October 2023 | Marbocyl™ SA 200mg Powder and Solvent for Solution for Injection |
Senvelgo 15 mg/ml oral solution for cats (GB) | New GB Marketing Authorisation | 30 October 2023 | Senvelgo 15 mg/ml oral solution for cats (GB) |
Galliprant tablets for dogs | Adverse reactions: updated | 22 August 2023 | Galliprant tablets for dogs |
Fortekor Plus tablets for dogs | Shelf life change from 18 months to 2 years (GB) | 13 October 2023 | Fortekor Plus tablets for dogs |
Baytril 25 mg/ml solution for injection | Adverse reactions – updated | 15 September 2023 | Baytril 25 mg/ml solution for injection |
Baytril Flavour Tablets | Special precautions/Adverse reactions/Interactions – updated | 15 September 2023 | Baytril Flavour Tablets |
Baytril 100 mg/ml solution for injection | Special precautions/Adverse reactions – updated | 15 September 2023 | Baytril 100 mg/ml solution for injection |
Baytril 2.5% Oral Solution | Adverse reactions/Interactions – updated | 15 September 2023 | Baytril 2.5% Oral Solution |
Baytril 50 mg/ml solution for injection | Special precautions/Adverse reactions – updated | 15 September 2023 | Baytril 50 mg/ml solution for injection |
Baytril Piglet Doser 0.5% Oral Solution | Special precautions/Adverse reactions/Interactions - updated | 15 September 2023 | Baytril Piglet Doser 0.5% Oral Solution |
Paramectin 0.5% w/v Pour-On Solution | Pharmaceutical particulars/Nature and composition of immediate packaging - Updated | 12 October 2023 | Paramectin 0.5% w/v Pour-On Solution |
Noromectin 1.87% Oral Paste for Horses (GB) | Marketing Authorisation Number - Now 02000/5009 | 12 October 2023 | Noromectin 1.87% Oral Paste for Horses (GB) |
Norodine Equine Oral Paste | Pharmaceutical particulars/List of excipients - Updated | 12 October 2023 | Norodine Equine Oral Paste |
Noroclav 50 mg Tablets for Dogs and Cats | Marketing Authorisation Number - Now 02000/5010 | 12 October 2023 | Noroclav 50 mg Tablets for Dogs and Cats |
Noroclav 50 mg Tablets for Dogs and Cats | Pharmaceutical particulars / Shelf-life - Updated | 12 October 2023 | Noroclav 50 mg Tablets for Dogs and Cats |
Noroclav 50 mg Tablets for Dogs and Cats | Pharmaceutical particulars / List of excipients - Updated | 12 October 2023 | Noroclav 50 mg Tablets for Dogs and Cats |
Noroclav 250 mg Tablets for Dogs | Pharmaceutical particulars / List of excipients - Updated | 11 October 2023 | Noroclav 250 mg Tablets for Dogs |
Enovex 0.5% w/v Pour-On Solution for Cattle | Pharmaceutical particulars / Nature and composition of immediate packaging - Paragraph changed | 11 October 2023 | Enovex 0.5% w/v Pour-On Solution for Cattle |
Porcilis® M Hyo ID ONCE emulsion for injection for pigs (GB) | Changes made to adverse reactions, interactions, overdose, disposal, MA number | 10 October 2023 | Porcilis® M Hyo ID ONCE emulsion for injection for pigs (GB) |
Deltafort 10 mg/ml Pour-on Solution | To implement changes in the SPC and package leaflet following the recommendation from the competent authority. Impacted sections of the SPC are sections 'Special precautions for use', 'Adverse reactions' and 'Interaction with other medicinal products and other forms of interaction'. Some of the amendments are proposed to ensure that the product literature for Deltafort 10 mg/ml Pour-on Solution is aligned with Deltanil 10 mg/ml Pour-on Solution for Cattle. | 17 August 2023 | Deltafort 10 mg/ml Pour-on Solution |
LEUCOGEN suspension for injection for cats | Changes in the SPC and package leaflet intended to implement the outcome of recommendations from the competent authority concerning risk management measures in pharmacovigilance related to veterinary medicinal product. | 20 September 2023 | LEUCOGEN suspension for injection for cats |
Bravecto® Plus spot-on solution for cats (GB) | Changes to indications for use, special warnings for each target species, special precautions for use, operator warnings, adverse reactions, amounts to be administered and administration route, pharmacodynamic properties, disposal, and MA number. | 28 September 2023 | Bravecto® Plus spot-on solution for cats (GB) |
Equisolon® 33 mg/g Oral Powder for Horses | New product | 24 July 2023 | Equisolon® 33 mg/g Oral Powder for Horses |
Avishield® IB H120, Lyophilisate for Oculonasal Suspension/Use in Drinking Water for Chickens | Addition of New Claim for Safety Use in Laying period | 12 June 2023 | Avishield® IB H120, Lyophilisate for Oculonasal Suspension/Use in Drinking Water for Chickens |
Zactran 150mg/ml solution for injection for cattle, sheep and pigs [GB] | Separate UK(GB) datasheet created as a result of update to latest GB QRD template. Haemophilus parasuis renamed Glaesserella parasuis. Updates to Sections Special Warnings, Special Precautions for use, Use during pregnancy, lactation or lay, Disposal. Adverse Events section now tabulated. | 19 September 2023 | Zactran 150mg/ml solution for injection for cattle, sheep and pigs [GB] |
Zactran 150mg/ml solution for injection for cattle, sheep and pigs [NI] | Separate UK(NI) datasheet created as a result of update to EU QRDv9 template. Haemophilus parasuis renamed Glaesserella parasuis. Updates to Sections Special Warnings, Special Precautions for use, Use during pregnancy, lactation or lay, Disposal. Adverse Events section now tabulated. | 24 August 2023 | Zactran 150mg/ml solution for injection for cattle, sheep and pigs [NI] |
Levafas Diamond Oral Suspension | CLINICAL PARTICULARS/Adverse reactions (frequency and seriousness) - Additional text re: Photosensitisation added | 13 September 2023 | Levafas Diamond Oral Suspension |
Bovalto Respi 3 suspension for injection [NI] | SPC updated to EU QRDv9 template. UK-wide licence split into UK(GB) and UK(NI) licence. This is the UK(NI) SPC. Mainly minor updates to fit existing text to new template. Adverse events now tabulated. Updated overdose information. | 11 August 2023 | Bovalto Respi 3 suspension for injection [NI] |
Bovalto Respi 3 suspension for injection [GB] | SPC updated to latest version of GB QRD template. UK-wide licence split into UK(GB) and UK(NI) licence. This is the UK(GB) SPC. Mainly minor updates to fit existing text to new template. Adverse events now tabulated. Updated overdose information. | 11 August 2023 | Bovalto Respi 3 suspension for injection [GB] |
Bovalto Respi 4 suspension for injection [GB] | SPC updated to latest version of GB QRD template. UK-wide licence split into UK(GB) and UK(NI) licence. This is the UK(GB) SPC. Mainly minor updates to fit existing text to new template. Adverse events now tabulated. Updated overdose information. | 11 August 2023 | Bovalto Respi 4 suspension for injection [GB] |
Bovalto Respi 4 suspension for injection [NI] | SPC updated to latest version of EU QRDv9 template. UK-wide licence split into UK(GB) and UK(NI) licence. This is the UK(NI) SPC. Mainly minor updates to fit existing text to new template. Adverse events now tabulated. Updated overdose information. | 11 August 2023 | Bovalto Respi 4 suspension for injection [NI] |
Pyroflam 50 mg/ml Solution for Injection for Cattle, Horses and Pigs | Pharmacological particulars - Environmental properties paragraph added | 04 September 2023 | Pyroflam 50 mg/ml Solution for Injection for Cattle, Horses and Pigs |
Pyroflam 50 mg/ml Solution for Injection for Cattle, Horses and Pigs | Clinical particulars/Special Precautions for Use (Special Precautions for use in animals) - additional paragraph added re: toxicity | 04 September 2023 | Pyroflam 50 mg/ml Solution for Injection for Cattle, Horses and Pigs |
Tiacil 0.50% w/v Eye drops, solution | SPC Adverse Events reviewed to add: Rare cases of local intolerance presented as conjunctival inflammatory reactions can be observed at the onset of treatment. In rare cases acute irritation and pain may occur. These reactions are transitory, and they disappear spontaneously without any specific treatment. | 30 August 2023 | Tiacil 0.50% w/v Eye drops, solution |
Alizin 30mg/ml solution for injection (NI) | Alignment of product information with version 9.0 of the QRD template. | 10 August 2023 | Alizin 30mg/ml solution for injection (NI) |
Levacur® SC 3%, oral solution | Changes to shelf life | 08 September 2023 | Levacur® SC 3%, oral solution |
Zeleris® 400 mg/ml + 5 mg/ml solution for injection for cattle | Updated indication with the addition of Mycoplasma bovis and associated warnings and precautions. For therapeutic treatment of bovine respiratory disease (BRD) due to Histophilus somni, Mannheimia haemolytica, Pasteurella multocida and Mycoplasma bovis associated with pyrexia. | 30 August 2023 | Zeleris® 400 mg/ml + 5 mg/ml solution for injection for cattle |
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 name of product, adverse reactions and MA number. | 29 August 2023 | Scalibor® Protectorband 0.76 g medicated collar for small and medium dogs and Scalibor® Protectorband 1.0 g medicated collar for large dogs |
VIMCO emulsion for injection for ewes and female goats | Northern Ireland: Update of Excipient listing, Adverse Events and Disposal of unused material. | 11 August 2023 | VIMCO emulsion for injection for ewes and female goats |
Mastiplan® LC, 300mg/20mg (Cefapirin/Prednisolone), intramammary suspension for lactating cows | Changes to pharmaceutical form, special precautions for use, operator warnings, adverse reactions, use during pregnancy or lactation, amounts to be administered and administration route, pharmacokinetic properties, immediate packaging, disposal and MA number. | 10 August 2023 | Mastiplan® LC, 300mg/20mg (Cefapirin/Prednisolone), intramammary suspension for lactating cows |
GUMBOHATCH lyophilisate and solvent for suspension for injection | In great Britain only: Instructions on mixing with Evanovo | 07 August 2023 | GUMBOHATCH lyophilisate and solvent for suspension for injection |
Semintra 4 mg/ml and 10 mg/ml oral solution for cats (GB) | Harmonised indications between 4 mg/ml and 10 mg/ml product (same indications for both products) | 21 July 2023 | Semintra 4 mg/ml and 10 mg/ml oral solution for cats (GB) |
Semintra 4 mg/ml and 10 mg/ml oral solution for cats (GB) | Change of syringe in 4 mg pack from kg syringe to ml syringe | 21 July 2023 | Semintra 4 mg/ml and 10 mg/ml oral solution for cats (GB) |
Semintra 4 mg/ml and 10 mg/ml oral solution for cats (GB) | Update format/layout of SPC; harmonisation of adverse events between 4 mg/ml and 10 mg/ml products | 21 July 2023 | Semintra 4 mg/ml and 10 mg/ml oral solution for cats (GB) |
Cyclix 250 microgram/ml solution for injection for Cattle (NI) | One-off alignment of the product information with version 9.0. | 13 July 2023 | Cyclix 250 microgram/ml solution for injection for Cattle (NI) |
Hiprabovis IBR Marker Live | Northern Ireland Excipient Update - Removal of Povidone as an excipient... | 10 July 2023 | Hiprabovis IBR Marker Live |
Simparica Trio chewable tablets for dogs | New clinical claims | 26 May 2023 | Simparica Trio chewable tablets for dogs |
Nobivac® Ducat lyophilisate and solvent for suspension for injection, for cats | Addition of special precautions for the protection of the environment, changes to amounts to be administered and administration route, pharmacodynamics properties, shelf life, storage, disposal and MA number. | 29 June 2023 | Nobivac® Ducat lyophilisate and solvent for suspension for injection, for cats |
Finadyne® Transdermal 50 mg/ml pour-on solution for cattle | Changes to excipients, pharmaceutical form, contraindications, special precautions for use, operator warnings, adverse reactions, amounts to be administered and administration routes, overdose, pharmacokinetic particulars, shelf life, disposal, MA number, and any other information. | 19 June 2023 | Finadyne® Transdermal 50 mg/ml pour-on solution for cattle |
MHYOSPHERE PCV ID emulsion for injection for pigs | Differences on GB SPC and NI SPC | 16 June 2023 | MHYOSPHERE PCV ID emulsion for injection for pigs |
MHYOSPHERE PCV ID emulsion for injection for pigs | Differences on administration details between the GB SPC and NI SPC | 16 June 2023 | MHYOSPHERE PCV ID emulsion for injection for pigs |
MHYOSPHERE PCV ID emulsion for injection for pigs | Differences on administration route between GB SPC and NI SPC | 16 June 2023 | MHYOSPHERE PCV ID emulsion for injection for pigs |
Canigen Parvo-C | Change(s) in the SPC, labelling or package leaflet to various sections. Changes to the product information: Safety warnings | 17 May 2023 | Canigen Parvo-C |
GUMBOHATCH lyophilisate and solvent for suspension for injection | NI only: directions for mixing with Evanovo | 15 June 2023 | GUMBOHATCH lyophilisate and solvent for suspension for injection |
GUMBOHATCH lyophilisate and solvent for suspension for injection | In NI Only: Specific details of use in future layers | 15 June 2023 | GUMBOHATCH lyophilisate and solvent for suspension for injection |
Hexasol LA Solution for Injection for Cattle | Clinical particulars/Special Precautions for Use (Special Precautions for use in animals) - additional paragraph added re: toxicity | 15 June 2023 | Hexasol LA Solution for Injection for Cattle |
Hexasol LA Solution for Injection for Cattle | Pharmacological particulars - Environmental properties paragraph added | 15 June 2023 | Hexasol LA Solution for Injection for Cattle |
Selectan | Addition of N-methyl pyrrolidone as an excipient and warnings regarding the evidence of foetotoxic effects in laboratory studies with this excipient in rats and rabbits | 13 June 2023 | Selectan |
Vetrimoxin® L.A. 150 mg/ml suspension for injection for cattle and pigs | Change in withdrawal period- Pigs. Reduced from 20 days to 16 days. | 06 June 2023 | Vetrimoxin® L.A. 150 mg/ml suspension for injection for cattle and pigs |
Cevac® MD Rispens concentrate and solvent for suspension for injection for chickens | Section 4.8 Interactions updated to include use with Cevac MD Rispens. | 09 May 2023 | Cevac® MD Rispens concentrate and solvent for suspension for injection for chickens |
Cardalis® 2.5 mg/20 mg, 5 mg/40 mg, 10 mg/80 mg chewable tablets for dogs | Adverse reactions- whole paragraph updated. | 09 May 2023 | Cardalis® 2.5 mg/20 mg, 5 mg/40 mg, 10 mg/80 mg chewable tablets for dogs |
Panacur® Granules 222 mg/g | Changes to product name, qualitative and quantitative composition, target species, adverse reactions, use during pregnancy, amounts to be administered and administration route and pharmacological properties. | 27 April 2023 | Panacur® Granules 222 mg/g |