Policy responses and statements

Name of organisation:

Medicines and Healthcare Products Regulatory Agency (MHRA)

Name of policy document:

ARM 61: Request to Reclassify a Product from POM to P - Domperidone 10mg tablets (Motilium 10)

Deadline for response:

7 May 2009

Background: The Medicines and Healthcare Products Regulatory Agency invited comments on this proposal to reclassify Domperidone 10mg tablets (Motilium 10) from POM to P. The active Ingredient in Motilium 10 is Domperidone maleate 12.72mg equivalent to 10mg domperidone. It is indicated for the relief of post-prandial symptoms of fullness, nausea, epigastric bloating and belching that is occasionally accompanied by epigastric discomfort and heartburn. It is also indicated for the relief of nausea and vomiting of less than 48 hours duration.

Download this consultation response as a .pdf

Copies of this response are available from:

Lesley Lockhart,
Royal College of Physicians of Edinburgh,
9 Queen Street,
Edinburgh,
EH2 1JQ.

Tel: 0131 225 7324 ext 608
Fax: 0131 220 3939

[5 May 2009]