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Ingelheim, Germany, 11 December 2012 - Boehringer Ingelheim’s Metacam® has today obtained EU wide marketing authorizations for use as an analgesic to relieve pain following dehorning in calves. Following the positive opinion of the CVMP, the European Medicines Agency’s (EMA) scientific committee, the EU commission announced their decision to authorize this new indication for Metacam® (active ingredient: meloxicam) 5mg/ml and 20 mg/ml solutions for injection.
The marketing authorization was granted based on a study performed at the Ontario Veterinary College, University of Guelph, in Canada examining the effect of meloxicam on stress parameters, pain sensitivity and on calf behavior. The study results demonstrated that meloxicam administered at 0.5 mg/kg bodyweight prior to cautery dehorning of 6 – 12 weeks old calves significantly reduced cortisol increases, a physiological marker for the response of the body to stress and pain. Moreover, meloxicam-treated calves had significantly lower heart and respiratory rates in the 24 hours after dehorning compared to the calves treated with placebo. In all, meloxicam-treated calves showed a quicker return to normal behavioral pattern as compared to animals which were not given analgesia.
With efforts underway to eventually discontinue the practice of dehorning in young calves through genetic selection for polled animals, dehorning will still need to be performed until then in order to reduce the later risk of injuries between animals and between man and animal.
Already licensed for this indication in Canada, meloxicam now is the first Non-Steroidal Anti-Inflammatory Drug specifically approved and available in the EU for the relief of pain following dehorning in calves.
"In many EU markets, changing attitudes meanwhile recommend the use of analgesia to help calves to better cope with pain and to more quickly recover from the dehorning procedure" says George Heidgerken, Head of Corporate Division Animal Health at Boehringer Ingelheim. "Metacam® now offers both veterinarians and farmers an authorized and provenly effective option to properly address the issue of pain relief following a routine husbandry procedure. This will support efforts to improve the well-being of calves."
Metacam® is a non-steroidal anti-inflammatory drug of the oxicam class. The product was first launched for cattle in 1998, and is now licensed in over 40 countries around the world. In the Netherlands, it is also marketed as Novem®.
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 44,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.
As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavors.
In 2011, Boehringer Ingelheim achieved net sales of about 13.2 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales.
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