Position on the sale and supply of co-proxamol following cancellation of the marketing authorisations at the end of 2007

14 December 2007

At the end of January 2005 the MHRA communicated the decision that the painkiller co-proxamol was to be withdrawn from the market.  This followed a 12-week exercise to gather further information on the risks and benefits of co-proxamol.  A decision was made to withdraw co-proxamol over a phased period of time – until the end of 2007 – to give patients a chance to move to suitable alternatives.

The marketing authorisations (MAs) for co-proxamol will be cancelled at the end of 2007.  No further stock should be released into the normal distribution chain by MA holders or their agents after 31 December 2007.  However, following withdrawal of the MAs it will remain legal to continue to supply co-proxamol released into the normal distribution chain prior to 31 December 2007 up until the product expiry date on the label has passed.  

To ensure any surplus stock is removed from the market once the MAs have been withdrawn, the MHRA has asked MA holders to undertake a voluntary withdrawal of stock and put in place arrangements to receive returned stock from both wholesale distributors and pharmacies (both community and hospital).

We recognise that there is a small group of patients who are likely to find it very difficult to change from co-proxamol or where alternatives appear not to be effective or suitable. For these patients, following cancellation of the licences at the end of 2007 there is a provision for the supply of unlicensed co-proxamol, on the responsibility of the prescriber.