MSD Animal Health has announced that the European authorities have recommended the granting of a marketing authorisation for the veterinary medicinal product Porcilis Lawsonia, an intramuscular vaccine against Lawsonia intracellularis for piglets.
Porcilis Lawsonia will be indicated for the active immunisation of pigs from three weeks of age to reduce: diarrhoea, loss of daily weight gain, intestinal lesions, bacterial shedding and mortality caused by Lawsonia intracellularis infection.
Porcilis Lawsonia will also be approved for mixing with Porcilis PCV M Hyo, providing the opportunity for protection against three major diseases affecting pigs in a single intramuscular vaccination: Lawsonia intracellularis, porcine circovirus type 2 (PCV2) and Mycoplasma hyopneumoniae (M. hyo).
Lawsonia intracellularis is a bacterium that causes ileitis, a gastrointestinal disease also known as porcine proliferative enteropathy. As one of the most common gastrointestinal problems in global swine production, ileitis affects pigs’ growth and development, resulting in a sizeable negative economic impact. The disease is present on 80% to 100% of European farms.
Following the positive decentralized procedure, EU countries are currently finalising their national registrations.
MSD Animal Health said that detailed product conditions are described in the Summary of Product Characteristics (SPC) and will be translated in all European Union languages for publishing by individual regulatory authorities.