The product (active ingredient: Meloxicam), 5mg/ml solution for injection, was granted authorisation following the positive opinion of the CVMP, the European Medicines Agency’s (EMEA) scientific committee.


Authorisation
The authorisation was expressed based on a specific study performed at the French Research Institute CTPA (Centre technique des productions animales et agro-alimentaires). The study confirmed a large body of evidence for the efficacy of Metacam generated earlier by the Faculty of Veterinary Medicine at the Ludwig-Maximilians-University in Munich, Germany.


It demonstrated that the product, administered at 0.4 mg/kg bodyweight prior to the castration of less than seven-day old piglets, had a significant impact on blood cortisol levels, a biochemical marker for the neuro endocrine reaction of the body to stress and pain.


The study also demonstrated quicker alleviation of clinical symptoms and faster return to normal behaviour in piglets which received the product in comparison to animals which were not given analgesia.


Pain relief
"This decision helps veterinarians and farmers to move out of a highly uncomfortable situation of wanting to apply pain relief, but not having a legal and authorised option for effective post operative pain management," said Dr Joachim Hasenmaier, the company's head of corporate division animal health.


"In many EU markets, changing attitudes meanwhile require or recommend the use of analgesia to help piglets to better cope with pain and to more quickly recover from the castration procedure. While the rationale was quickly adapted and accepted by veterinarians and farmers alike, no labelled product options were available for use which left them with the uneasy alternative of either not applying analgesia or of entering into unauthorised, off-label use of potential product options. This situation has ended now."


The product, a non-steroidal anti-inflammatory drug of the oxicam class, was first launched for pigs in 2003, and is now licensed in over 40 countries around the world.


Related website:
• Boehringer Ingelheim Animal Health