Detail of outcome
The Medicines and Healthcare products Regulatory Agency (MHRA) has agreed to reclassify Nexium Control from a pharmacy (P) medicine to a general sales list medicine (GSL) in the UK for the short-term treatment of reflux symptoms (eg heartburn and acid regurgitation) in adults.
See the public assessment report for more information.
Detail of feedback received
A total of 10 responses were received, of which 2 were in favour, 4 raised issues and 4 were not in favour. Two of the responses were confidential.
MHRA is asking for feedback on proposals to classify Nexium Control 20mg Gastro-Resistant tablets as a general sales list (GSL) product in the UK. The GSL classification summary and label and patient information leaflet as provided by the company are included in this document.