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news.Labopharm has received regulatory approval for its once-daily tramadol product for the treatment of moderate to severe pain in 22 European countries.
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This approval was gained through the mutual recognition procedure (MRP), under which Labopharm has reached agreement with the 22 countries on a common product label. The MRP will direct these countries to issue marketing authorization and Labopharm expects marketing authorizations from individual countries will begin to be received within 30 days following its announcement and continuing into the first half of 2006.
“Regulatory approval under MRP allows us to launch our once-daily product in the large and growing European tramadol market following receipt of marketing authorizations from the individual countries,” said James Howard-Tripp, president and CEO of Labopharm.
The countries covered by the approval include Germany, the UK, Italy, Spain, the Czech Republic, the Netherlands, and Sweden. Labopharm has already received regulatory approval for the product in France and will continue to pursue regulatory approval for other key European markets.
The label agreed to includes both acute and chronic pain in a dose range from 100 to 400mg per day.