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High Dosage St. John's Wort Preparation Registered As Traditional Herbal Medicinal Product in UK

 

NewswireToday - /newswire/ - Menster, North Rhine-Westfalia, Germany, 03/19/2008 - HyperiCalm is the first THMP with St. John's wort extract in the UK. It was developed by Diapharm, the holder of the registration is MH Pharma UK Ltd, a subsidiary of Dr. Willmar Schwabe group.

   
 

With HyperiCalm® the British regulatory authority MHRA has for the first time registered a medicinal product with St. John's wort extract on the basis of the EU Directive 2004/24/EC. Its therapeutic indication is "for the relief of slightly low mood and mild anxiety, based on traditional use only“. The medicinal product was developed by the pharmaceutical service provider Diapharm. The holder of the registration is Diapharm's British partner, MH Pharma UK Ltd, which since January 2008 belongs to the Dr. Willmar Schwabe group in Karlsruhe (Germany).

Through the strategic acquisition in Great Britain, Schwabe now possesses a portfolio of seven registrations of traditional herbal medicinal products which MH Pharma UK Ltd has successfully obtained in the last few months with the help of Diapharm. "With the take-over by Dr. Willmar Schwabe GmbH, we anticipate that HyperiCalm® will prove itself on the UK market, since Schwabe already has many years of experience in the marketing of St. John's wort products, particularly in Germany", states Diapharm's managing director Dr. Rainer Kolkmann.

The registration of HyperiCalm® as a traditional herbal medicinal product is regarded as a milestone on the way to more safety in relation to pharmaceuticals in the British phyto-pharma market: up until now, such products were often marketed in Great Britain as "unlicensed products", i.e. as foodstuffs without any effective control by the authorities. With the implementation of the EU Directive 2004/24/EC, such traditionally used herbal preparations must be registered as medicinal products and their quality and their satisfaction of the health and safety criteria proven.

 
 
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