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EU backs approval of Boehringer Ingelheim's FLEXcombo
Ingelheim, Germany | Friday, May 28, 2010, 08:00 Hrs  [IST]

The Committee for Medicinal Products for Veterinary Use (CVMP) has recommended to approve FLEXcombo, the combined use of the veterinary medicinal products Ingelvac CircoFLEX and Ingelvac MycoFLEX, in the European Union. The simultaneous administration of both vaccines represents an innovation in of pig health management. From now on, the two most prominent and costly diseases, Porcine Circovirus Disease (PCVD) and Enzootic Pneumonia, can be prevented with a single injection instead of up to four injections. Today an average of more than 70 per cent of European pigs receive vaccines for these two diseases.

The CVMP is responsible for the assessment of any modifications to the existing marketing authorisation. Assessments conducted by the CVMP are based on purely scientific criteria and determine whether products meet the necessary quality, safety and efficacy requirements.

The combined use of Ingelvac CircoFLEX and Ingelvac MycoFLEX is already registered in North America (e.g. USA and Canada), Asia (e.g. Philippines and South Korea) and in Oceania (New Zealand). It is globally the first and only product of its kind. With this combination of vaccines, pigs can be protected against PCVD and Enzootic Pneumonia in an easy and effective manner. In addition, vaccination schedules can be targeted to specific epidemiological disease situations. This can enhance and improve animal welfare as well as overall animal husbandry (e.g. by decreasing vaccination stress and animal handling by half).

Ingelvac CircoFLEX is registered for use as a single vaccination for pigs around weaning against the clinical signs associated with porcine circovirus type 2 (PCV2) including mortality, weight loss and lesions in lymphoid tissues. It is based on ImpranFLEX, a unique adjuvant platform. Ingelvac CircoFLEX is the global market leading PCV2 vaccine.

Ingelvac MycoFLEX is a vaccine for the active immunisation of pigs aged three weeks and more to reduce lung lesions following infection with Mycoplasma hyopneumoniae. It is based on ImpranFLEX, a unique adjuvant platform. Ingelvac MycoFLEX was first launched in the US in 2008 where it became the leading Mycoplasma vaccine within a few months.

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