Research and analysis

Public Assessment Report of the reclassification of Buscopan IBS Relief, Hyoscine Butylbromide 10mg tablets

This PAR covers the assessment of the proposal to make Buscopan IBS Relief, Hyoscine Butylbromide 10mg tablets available through general retail outlets.

From:
Medicines and Healthcare products Regulatory Agency
Published
11 February 2022

Documents

Public Assessment Report of the reclassification of Buscopan IBS Relief, Hyoscine Butylbromide 10mg tablets

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Public Assessment Report of the reclassification of Buscopan IBS Relief, Hyoscine Butylbromide 10mg tablets

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Details

Buscopan IBS Relief can be used in adults and children aged 12 years and over for the relief of gastro-intestinal tract spasm associated with medically confirmed irritable bowel syndrome (IBS).

Each tablet contains 10 milligrams (mg) of hyoscine butylbromide.

The licence holder , Opella Healthcare UK Limited, applied to make a pack size of 60 tablets of Buscopan IBS Relief available as a General Sales List medicine for sale through general retail outlets (see Background for definition).

The Medicines and Healthcare Products Regulatory Agency (MHRA) considers this product sufficiently safe to be sold on general sale. This report outlines the evidence that the MHRA reviewed and which led to the decision to approve the application.

Published 11 February 2022

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