Navamedic's osteoarthritis product approved in 19 European countries

By Lisa Kerner

Erie, Pa., Jan. 17 - Navamedic's glucosamine HCl product has been approved in 19 countries for treatment of osteoarthritis of the knee, according to a company news release.

The product was approved in Sweden in August 2005, and has now been reviewed in the European Mutual Recognition Procedure.

The product will be marketed under Glucomed and other brands names. Countries that 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.

Osteoarthritis is the most widespread form of arthritis, and glucosamine is a generic active ingredient against osteoarthritis symptoms. The company is currently building a network of marketing and distribution partners across Europe for its Glucomed product.

"We are happy to see that a majority of the E.U./E.E.A. states have approved our product for medicinal use. This is in line with the regulatory trend we have foreseen. We will now focus on the launch of our product in those markets where we already have established sales, marketing and distribution agreements and intensify the work in expanding our distribution network further," chief executive officer of Navamedic, Oyvind Brekke, said in the release.

Austria, France, Germany, Greece and the United Kingdom have not approved the product, due mainly to evaluation of the efficacy documentation of the active substance, said the company. The application will now be referred to E.U.'s co-ordination group for mutual recognition.

If the case is not resolved in the relevant committees, the EU Commission will be the final deciding authority, an 18-month process.

Navamedic is a Norwegian specialty pharmaceutical company focusing on the development and production of glucosamine HCl based medicines. The company is based in Lysaker, Norway.

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