Navamedic's glucosamine HCl product approved in 19 European countries for treatment of osteoarthritis

19-Jan-2006

Based on the approval of Glucomed®, granted by the Swedish Medical Products Agency on 4 August 2005, Navamedic launched an MRP application in 24 additional EU/EEA countries on 18 October. The 90 day procedure thus ended on 16 January 2006 and Navamedic has received notice that its product has been approved in 19 countries in addition to Sweden as Reference Member State. Five countries have so far not approved the application.

Osteoarthritis is the most widespread form of arthritis, and glucosamine is a generic active ingredient against osteoarthritis symptoms. Navamedic considers the glucosamine market an attractive high growth opportunity, and believes Glucomed® will be a highly competitive product. The company is currently building a network of marketing and distribution partners across Europe.

Navamedic expects National Marketing Authorizations to be issued in most of the 19 countries over the next months, following approval of national product information for doctors and patients. The product will be marketed under Glucomed® and other brands names. Countries having approved the application are Belgium, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Portugal, Slovakia and Spain.

Austria, France, Germany, Greece and the United Kingdom have so far not approved the product. Outstanding issues are mainly related to these authorities' evaluation of the efficacy documentation of the active substance. The application will now be referred to EU's co-ordination group for mutual recognition and decentralised procedures (CMD), and further to EU's pharmaceutical committee (CPMP) if consensus is not achieved in the CMD.

https://www.bionity.com/en/news/51691/navamedic-s-glucosamine-hcl-product-approved-in-19-european-countries-for-treatment-of-osteoarthritis.html