Movetis receives authorisation to market Resolor in Switzerland
Switzerland is the 31st country where Resolor is authorised on the market
Movetis NV announced that it has received a letter from Swissmedic with the authorisation to market its lead product, Resolor (prucalopride), in Switzerland.
Swissmedic granted marketing authorisation of Resolor 1mg and 2mg tablets on doctor’s prescription with the following statement: “Resolor is indicated for treatment of idiopathic chronic constipation in adults for whom the currently available treatment options involving dietary measures and laxatives do not provide sufficient effect. There are currently no sufficient data available to evaluate the effectiveness and safety of Resolor in men.”
The marketing authorisation application for Resolor was submitted to Swissmedic in the first half of 2008. The favourable risk/benefit profile of Resolor in chronic constipation in women has been demonstrated in a clinical development programme with over 3,000 patients treated for the equivalent of more than 2,600 patient years.
Dirk Reyn, CEO of Movetis, commented: “This is very good news for Movetis as well as for Swiss GI specialists, who can now look forward to the imminent availability of this novel enterokinetic agent that targets impaired gut motility associated with chronic constipation. Resolor is already available on the market in the UK and Germany. Movetis continues to prepare for launching Resolor in other European countries with market authorisation.”
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