MHRA-LOGO.gif (6825 bytes) Medicines and Healthcare products
Regulatory Agency

Market Towers
1 Nine Elms Lane, London SW8 5NQ


Mr Charles Medawar
Social Audit Ltd
P.O. Box 111
London NW1 8XG

General enquiries
Telephone 020 7273 0000  Fax 020 7273 0353
E-mail [email protected]

Direct line:  020 7084 2763
Email:   [email protected]


9 June 2006    
FOI 06-149   

Dear Mr Medawar,

Subject : Seroxat

Thank you for your letter of 16 May 2006 to Dr Williams asking about the controlled release formulation for paroxetine.

I can confirm that the analysis of data from placebo- and active-controlled trials considered by the Expert Working Group did not differentiate between the controlled and immediate release formulations of paroxetine. The data recently published by GSK are currently under review at a European level to see what implications they have for the current Summary of Product Characteristics and Patient Information Leaflet. I will raise the concerns that you have expressed your letter during these discussions.

We do not have record of receipt within the Agency of an application for a licence for a paroxetine controlled release formulation.

Yours sincerely,

Sarah Wark