| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
Suiseng Coli / C | Extension of shelf-life, just for Northern Ireland | 15 July 2024 | Suiseng Coli / C |
Suiseng Coli / C | Extension of shelf-life, just for Northern Ireland | 15 July 2024 | Suiseng Coli / C |
Suiseng Coli / C | Extension of shelf-life, just for Northern Ireland | 15 July 2024 | Suiseng Coli / C |
Suiseng Coli / C | Extension of shelf-life, just for Northern Ireland | 15 July 2024 | Suiseng Coli / C |
Suiseng Coli / C | Extension of shelf-life, just for Northern Ireland | 15 July 2024 | Suiseng Coli / C |
Suiseng Coli / C | Extension of shelf-life, just for Northern Ireland. Extension to 24 months. | 15 July 2024 | Suiseng Coli / C |
Fortekor Flavour tablets for cats and dogs (GB) | Changes to Adverse reactions (frequency and seriousness) | 12 July 2024 | Fortekor Flavour tablets for cats and dogs (GB) |
Fortekor 2.5 mg tablets for cats and dogs (GB) | Update to Adverse reactions (frequency and seriousness) | 12 July 2024 | Fortekor 2.5 mg tablets for cats and dogs (GB) |
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 |
| | | |
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 | 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) |
Bovilis Cryptium® emulsion for injection for cattle (NI) | New datasheet | 22 May 2024 | Bovilis Cryptium® emulsion for injection for cattle (NI) |
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 - UK(GB) | 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 - UK(GB) |
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 |
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) |
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 |
MHYOSPHERE PCV ID emulsion for injection for pigs | Variation in the SPC only for NI regarding point 6.6 "Special precautions for disposal ... " | 23 January 2024 | MHYOSPHERE PCV ID 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 |
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) |
Fortekor Plus tablets for dogs | Shelf life change from 18 months to 2 years (GB) | 13 October 2023 | Fortekor Plus tablets for dogs |
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) |