The Danish Medicines Agency has decided to suspend the marketing authorisation for the medicinal product Somadril® with effect from 2 June 2008.
The decision was made on 29 February 2008 in continuation of the European Commission's decision of 5 February 2008 to suspend all national marketing authorisations for carisoprodol-containing human medicinal products. The European Commission has concluded that the risk-benefit balance is no longer favourable.
See our previous announcement regarding carisoprodol-containing medicinal products in the factbox to the right.
Consequently, Somadril® will no longer be available on the market after 1 June 2008. The date of suspension has been set to give patients who are being treated with Somadril® sufficient time to switch to another relevant product.
For further information, please contact Jakob Lundsteen, +45 4488 9204 or jal@dkma.dk.
The Danish Medicines Agency, 5 March 2008
