Following non-submission
AWMSG advice |
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| Status: Not endorsed (Statement of Advice) | ||
In the absence of a submission from the holder of the marketing authorisation, vildagliptin/metformin hydrochloride (Eucreas®) cannot be endorsed for use within NHS Wales for: treatment of type 2 diabetes mellitus in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled with metformin and a sulphonylurea; or treatment of type 2 diabetes mellitus as triple combination therapy with insulin as an adjunct to diet and exercise to improve glycaemic control in patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control. |
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Medicine details |
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| Medicine name | vildagliptin/metformin hydrochloride (Eucreas®) | |
| Formulation | 50 mg/850 mg film-coated tablet, 50 mg/1000 mg film-coated tablet | |
| Reference number | 1930 | |
| Indication | for the treatment of type 2 diabetes mellitus in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled with metformin and a sulphonylurea; or treatment of type 2 diabetes mellitus as triple combination therapy with insulin as an adjunct to diet and exercise to improve glycaemic control in patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control. |
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| Company | Novartis Pharmaceuticals UK Ltd | |
| BNF chapter | Endocrine system | |
| Assessment type | Non-submission | |
| Status | Not endorsed (Statement of Advice) | |
| Ratification by Welsh Government | 18/03/2013 | |
| Date of issue | 22/03/2013 | |