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Prionics has received marketing authorization for its Tuberculin PPD

Prionics Lelystad B.V. has received marketing authorization for its Tuberculin PPD in the United Kingdom, Ireland and the Netherlands. The Tuberculin PPD (Bovine and Avian Tuberculin PPD) successfully passed the extensive decentralized approval procedure as laid down in EC Directive 2001/82/EC in these three EU countries.

Bovine tuberculosis (TB) is an important infectious and chronic disease amongst cattle that can result in severe economic losses to farming operations. Transmission of the disease to humans is possible and could cause public health issues. Without appropriate control measures bovine TB spreads quickly. TB control programs in the European Union are obliged to use the intradermal skin test with tuberculin PPD as the primary screening tool for bovine TB (Annex B of Council Directive 64/432/EEC).

The Tuberculin PPD from Prionics has been successfully used throughout Ireland since 1979 and in the United Kingdom (UK) since 2005. A prerequisite for being granted the recent UK and Irish tenders was the timely registration of these products via the official marketing authorization procedure. 'By granting marketing authorization the UK, Ireland and the Netherlands have confirmed that our product fulfils all requirements for quality, safety and efficacy', says Dr. Markus Moser, CEO of Prionics. 'With both the BOVIGAM® test (the only validated and OIE approved laboratory test for bovine TB) and the Tuberculin PPD Kit, Prionics is able to make a significant contribution to the control of TB in cattle', says Ernst Zollinger, CMO of Prionics.

Proven safety and efficacy
The Prionics Tuberculin PPD is controlled for quality according to the standards described in the European Pharmacopoeia monographs [0535] and [0536]. Prionics has demonstrated the safety and efficacy of its Tuberculin PPD through laboratory studies and with the long-term use in Ireland and the UK. The approval by the UK, Ireland and the Netherlands will facilitate the use of this registered product in other EU countries. Marketing authorization applications will be soon filed for this product in other European countries.

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Source : Prionics AG View Company Information

Posted on March 21, 2011