Medicines News November 2020
Medicines news
Medicines regulation
Every year, the Veterinary Medicines Directorate (VMD) and Veterinary Products Committee hold an open information day. This year, like everything else, it’s online, consisting of pre-recorded webinars that will be available from Wednesday 18 November. But that means that the information will accessible to more people than can usually get the event in person. For more about the event click here.
Newly marketed veterinary medicines
There is usually a delay between a product receiving a marketing authorisation from the VMD or EMA and being available for use. The following are products that have recently been launched onto the market.
prednisolone tablets for horses (Equipred). POM-V. (First authorised in November 2019). For alleviation of inflammatory and clinical parameters associated with recurrent airway obstruction (RAO – severe asthma) in horses, in combination with environmental control. This is a new equine prednisolone option and an addition to the single existing authorised product Equisolon powder.
hyoscine + metamizole injection (Sympagesic) for horses, dogs, cattle and pigs. All four species: Treatment of smooth muscle spasms and pain associated with underlying disorders of the gastro-intestinal tract, urogenital system and bile excretory organs. Horses only: Spasmodic colics. Cattle, pigs, dogs: Supportive therapy for acute diarrhoea and gastroenteritis. POM-V (First authorised May 2019). Similar products: Buscopan Compositum, Spasmium Comp.
Newly authorised veterinary medicines
The following medicines have been authorised by the VMD in the past month. Newly authorised medicines usually do not appear on the market for several months.
Newly authorised medicines for small animals and horses
benzylpenicillin sodium injection (brand name Geepenil – Orion) for horses. POM-V
praziquantel spot-on (Prazpronto – Channelle) for cats. AVM-GSL
Newly authorised medicines for food-production animals
tulathromycin injection (Increxxa – Elanco) for cattle, pigs and sheep. POM-V
tulathromycin injection (Tulinovet – VMD NV) for cattle, pigs and sheep. POM-V
tulathromycin injection (Tullavis – Livisto) for cattle, pigs and sheep. POM-V
Turkey herpesvirus vaccine (Innovax ND-ILT – Intervet) for chickens. POM-V
Mycoplasma hypopneumoniae vaccine (Mhyosphere PCV ID – Laboratorios Hippra) for pigs. POM-V
Changes to product information – companion animals
Eurican L multi suspension for injection (Leptospira canicola, Leptospira grippotyphosa, Leptospira icterohaemorrhagiae) for dogs. New adverse effects information added to the SPC: ‘Transient lethargy and emesis may also commonly be observed. Hypersensitivity reactions (facial oedema, anaphylactic shock, urticaria) may rarely occur, some of which are life-threatening may rarely occur as with any vaccine. In such cases, appropriate symptomatic treatment should promptly be provided’.
Purevax FeLV (Feline leukemia virus) for cats. New adverse effects information added to the SPC: ‘Anorexia and emesis have been reported very rarely based on post marketing safety experience. A hypersensitivity reaction may occur in very rare cases. Such reactions may evolve to a more severe condition (anaphylaxis). If such reactions occur, appropriate treatment is recommended.’
Changes to product information – food-production animals
Hexasol LA solution for injection for cattle (flunixin, oxytetracycline) New adverse effects information added to the SPC: ‘Hypersensitivity reactions (collapse) may occur very rarely. Such reactions may evolve to a more severe condition (anaphylaxis), which may be life-threatening.’
The up-to-date SPCs for all the products can be viewed on the VMD product information database.
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