Registrations for four new traditional herbal medicinal products for the treatment of sleep disturbances have just been granted to the German pharmaceutical service provider Diapharm by the UK's Medicines and Healthcare products Regulatory Agency (MHRA).
The registrations for DiaNight, DiaNight Plus, DiaSleep and DiaSleep Plus are to be offered for sale. DiaNight and DiaSleep are single-substance preparations in which one sugar-coated tablet contains 150mg of valerian root extract. DiaNight Plus and DiaSleep Plus are combination preparations, each sugar-coated tablet containing 125mg of valerian root extract and 250mg of passiflora extract. According to the MHRA, the products are indicated "for the temporary relief of sleep disturbances due to symptoms of mild anxiety, based on traditional use only."
Registration was granted on the basis of European Union Directive 2004/24/EC. Regulatory services for medicinal products are one of Diapharm's main areas of activity. In particular, the firm collaborates with manufacturers of traditional herbal medicinal products and more information on it is available at: www.diapharm.com.
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