Consultation outcome

Classification of Nexium Control 20mg Gastro-Resistant

• From: Medicines and Healthcare products Regulatory Agency
• Published: 2 July 2014
• Last updated: 27 January 2015 — See all updates

This consultation has concluded

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.

See all the reponses to this consultation.

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Original consultation

Summary

This consultation (ARM88) welcomes views on proposals to classify Nexium Control 20mg Gastro-Resistant Tablets as a general sales list (GSL) product in the UK.

This consultation ran from
2 July 2014 to 10:45pm on 23 July 2014

Consultation description

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.

Documents

Consultation document, ARM88 - Nexium Control 20mg Gastro-Resistant Tablets - request to classify as GSL

PDF, 3.5 MB, 18 pages

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Published 2 July 2014

Last updated 27 January 2015 + show all updates

1. 27 January 2015

   The responses to and outcome of this consultation have been published.

2. 2 July 2014

   First published.