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metformin hydrochloride (Glucophage SR®)

 

Following non-submission

AWMSG advice

Status: Not endorsed (Statement of Advice)

In the absence of a submission from the holder of the marketing authorisation, metformin hydrochloride (Glucophage SR®) cannot be endorsed for use within NHS Wales for the reduction in the risk or delay of the onset of type 2 diabetes mellitus in adult, overweight patients with IGT and/or IFG, and/or increased HbA1C who are: at high risk for developing overt type 2 diabetes mellitus and; still progressing towards type 2 diabetes mellitus despite implementation of intensive lifestyle change for 3 to 6 months. Treatment with Glucophage SR® must be based on a risk score incorporating appropriate measures of glycaemic control and including evidence of high cardiovascular risk. Lifestyle modifications should be continued when metformin is initiated, unless the patient is unable to do so because of medical reasons.

 Statement of advice (SOA): metformin hydrochloride (Glucophage SR) 3450 (PDF, 97Kb)

Medicine details

Medicine name metformin hydrochloride (Glucophage SR®)
Formulation 500 mg prolonged-release tablet, 750 mg prolonged-release tablet, 1000 mg prolonged-release tablet
Reference number 3450
Indication

For the reduction in the risk or delay of the onset of type 2 diabetes mellitus in adult, overweight patients with IGT and/or IFG, and/or increased HbA1C who are: at high risk for developing overt type 2 diabetes mellitus and; still progressing towards type 2 diabetes mellitus despite implementation of intensive lifestyle change for 3 to 6 months. 

Company Merck Serono Ltd
BNF chapter Endocrine system
Submission type Non-submission
Status Not endorsed (Statement of Advice)
Ratification by Welsh Government 16/10/2017
Date of issue 17/10/2017
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