Seroxat USERS collaborate with GSK & MHRA to approve Patient Info Leaflet

http://www.mhra.gov.uk/home/groups/pl-p/documents/committeedocument/con003475.pdf

6.2 DRAFT SEROXAT PATIENT INFORMATION LEAFLET


6.2.1 The Group was informed that the Seroxat Patient Information Leaflet (PIL) will form a key component of any communications around the time of European Commission Decision in relation to the Article 31 referral for paroxetine.

6.2.2 Upon request GSK has submitted an amended version of the Seroxat PIL that reflects the changes to the product information for prescribers recommended

H:JW/SSRIEWGMINSMTG13.doc

by the recommended by the Committee for Medicinal Products for Human Use. GSK has also outlined its plans to user test this leaflet using a company called Consumation. The Group was informed that the MHRA was also planning to have users independently test the leaflet and commitments had been given to various stakeholders that their comments would be sought.


6.2.3 The Group was informed that GSK was provided with initial feedback on the draft Seroxat PIL during a meeting held between the MHRA and GSK on 15 July 2004. In light of these discussions GSK has provided a further draft which takes these comments into account. The Group had the following comments about the content and format of the revised draft Seroxat PIL:


extract from -
COMMITTEE ON SAFETY OF MEDICINES


EXPERT GROUP ON SAFETY OF SSRIs

MINUTES OF THE MEETING OF THE CSM EXPERT GROUP ON THE SAFETY OF SSRIS HELD ON WEDNESDAY 23 JULY 2004 AT 10AM IN CR1 AT MARKET TOWERS.