following an abbreviated submission:
saxagliptin/dapagliflozin 5mg/10mg (Qtern®) is accepted for restricted use within NHS Scotland.
Indication under review: in adults aged 18 years and older with type 2 diabetes mellitus:
-
to improve glycaemic control when metformin and/or sulphonylurea and one of the monocomponents of Qtern® do not provide adequate glycaemic control,
-
when already being treated with the free combination of dapagliflozin and saxagliptin
SMC restriction: for use in combination with metformin when the use of a sulphonylurea is inappropriate.
In patients for whom this combination is appropriate, saxagliptin/dapagliflozin (Qtern) offers a single tablet at a lower cost per dose compared with the individual components.
The marketing authorisation for saxagliptin currently specifies the medicines that may be given concomitantly but is to be amended to ‘use in combination with other diabetes medicines’. It is anticipated that this licence change will be outwith SMC remit.
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Medicine details
- Medicine name:
- saxagliptin/dapagliflozin fixed dose combination (Qtern)
- SMC ID:
- 1255/17
- Indication:
- in adults aged 18 years and older with type 2 diabetes mellitus: to improve glycaemic control when metformin and/or sulphonylurea and one of the monocomponents of Qtern® do not provide adequate glycaemic control. When already being treated with the free combination of dapagliflozin and saxagliptin
- Pharmaceutical company
- AstraZeneca UK Ltd
- BNF chapter
- Endocrine system
- Submission type
- Abbreviated
- Status
- Restricted
- Date advice published
- 10 July 2017
The marketing authorisation for saxagliptin was amended to cover use in combination with other diabetes medicines in July 2017. This minor licence change will not be assessed.