This medicines update is provided by the Veterinary Medicines Directorate (VMD) and lists new active substance, new marketing authorisations and changes to authorisations most relevant to vets.
Changes to authorisations most relevant to vets
The changes to authorisations most relevant to vets can be found below. Each product is listed, along with the authorisation holder, distribution category and details of which Summary of Product Characteristics sections have been revised/changed.
All entries can be found on the VMD’s Product Information Database here.
Changes to the SPC, labels and leaflets may change how the medicines should be used. There may be a delay between these changes being authorised to implementation on product literature. Unless you have been advised otherwise, the labelling instructions on the pack which is dispensed should be followed.
Equest Pramox 19.5 mg/g + 121.7 mg/g Oral Gel [Horses]
Zoetis UK Limited GB & NI POM-VPS
Section 4.6: Digestive discomfort (colic, loose stool) has been observed in very rare cases based on post-marketing surveillance data.
Equilis Prequenza, Suspension for Injection, for Horses
MSD Animal Health UK Limited GB POM-V
Section 4.6: Added Hypersensitivity reaction.
Subestin 25 microgram/ml Oral Solution for Horses
Floris Animal Health Limited GB POM-V
Section 4.6: Updated to include lethargy as an adverse event of rare frequency.
Section 4.7: If used during pregnancy, treatment must be discontinued a minimum of 4 days before the expected time of delivery or at signs of approaching parturition, since uterine contractions may be abolished or labour may be prolonged.
For more information, contact the VMD at firstname.lastname@example.org