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PRZOOM - /newswire/ -
Muenster, North Rhine-Westfalia, Germany, 2009/03/18 - Schwabe Pharma (UK) has been granted a registration for the traditional herbal medicinal product "RelaxHerb" in the UK. The registration was achieved with the help of regulatory service provider Diapharm.
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The decision by the British Medicines and Healthcare products Regulatory Agency (MHRA) on “RelaxHerb” in early March 2009 was double cause for celebration, in Marlow in the UK and in Oldenburg, Germany: firstly by registration holder Schwabe Pharma (UK) Ltd. which, with the traditional herbal medicinal product, now has in its portfolio a product for alleviating symptoms associated with stress. And secondly by regulatory service provider Diapharm which prepared the necessary quality dossier and evidence of traditional use for Schwabe. RelaxHerb is the thirteenth United Kingdom registration managed by Diapharm: “Every second traditional herbal medicinal product there is registered on the basis of dossiers from our company”, emphasises Diapharm General Manager Dr. Rainer Kolkmann.
Apart from the United Kingdom, Diapharm (diapharm.de) is also active in traditional-use registrations on the basis of EU Directive 2004/24/EC in Austria, the Czech Republic, Germany, Hungary, Lithuania, Poland, Portugal and Spain. The company’s main area of activity is in regulatory, medical and pharmaceutical consultancy and the management of medicinal product marketing authorisations and OTC products.
RelaxHerb contains 425 mg of passiflora extract per tablet. The indication registered by the MHRA is “for the temporary relief of symptoms associated with stress such as mild anxiety”. The United Kingdom has so far registered a total of 26 traditional herbal medicinal products – more than any other country in Europe.
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