This consultation sought views on the GSL classification of Nexium Control 20mg Gastro-Resistant Tablets.Following an application through the centralised procedure Nexium Control was approved as a non-prescription medicine by the European Commission on 26 August 2013. A medicine classified through the centralised procedure as non-prescription can be classified as either P or GSL in the UK. The Marketing Authorisation Holder has submitted evidence to seek to demonstrate that the product may be considered to meet the conditions for GSL supply in the UK.
Royal College of Physicians of Edinburgh Response to the Medicines and Healthcare Products Regulatory Agency on Arm 88: Nexium Control 20mg Gastro-Resistant Tablets - Request to Classify a Product as GSL
The Royal College of Physicians of Edinburgh is pleased to respond to the MHRA on its consultation on the request to include Nexium Control 20mg Gastro-Resistant Tablets as a General Sales List (GSL) medicine.
The College has reservations about this request from the Marketing Authorisation Holder. The S-isomer of omeprazole is broadly twice as powerful as standard omeprazole and its use is restricted in some areas to prescription by GI physicians. If patients find a more straightforward acid suppressant insufficient then further investigation is warranted, and patients should be discouraged from using excessively powerful medicines unless clinically indicated. There also is a risk to patients if they fail to follow instructions carefully, even when displayed on the face of the packaging.