MHRA assessment of Sigesbeckia

Admin News

On February 18th, 2015, the Medicines and Healthcare products Regulatory Agency (MHRA) granted Phynova Group Ltd a Traditional Herbal Registration Certificate for the product Phynova Joint and Muscle Relief Tablets (Traditional Herbal Registration number: THR 41783/0001).  Phynova Joint and Muscle Relief Tablets are available without prescription and c an be bought from pharmacies and other outlets.

The active ingredient comes from the aerial parts of the Sigesbeckia orientalis L subsp. pubescens (Makino) H. Koyama plant.  Phynova Joint and Muscle Relief Tablets is a traditional herbal medicinal product for the relief of backache, minor sports injuries, rheumatic or muscular pains and general aches and pains in the muscles and joint, based on traditional use only.

The registration is based exclusively upon longstanding use of Sigesbeckia aerial parts as a traditional medicine and not upon data generated from clinical trials.

No new or unexpected safety concerns arose from this application and it was, therefore, decided that a Traditional Herbal Registration Certificate could be granted.

http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con512962.pdf