Sitagliptin SUN

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sitagliptin fumarate

Authorised
This medicine is authorised for use in the European Union.

Overview

Sitagliptin SUN is a medicine used to control blood glucose (sugar) levels in adults with type 2 diabetes. It is used together with diet and exercise in the following ways:

  • on its own, in patients whose blood glucose levels are not satisfactorily controlled with diet and exercise and who cannot take metformin (a diabetes medicine);
  • in combination with metformin or a PPAR-gamma agonist (a type of diabetes medicine) such as a thiazolidinedione, in patients whose blood glucose levels are not satisfactorily controlled with metformin or the PPAR-gamma agonist used on its own;
  • in combination with a sulphonylurea (another diabetes medicine) in patients whose blood glucose levels are not satisfactorily controlled with a sulphonylurea used on its own and who cannot take metformin;
  • in combination with both metformin and a sulphonylurea or a PPAR-gamma agonist, in patients whose blood glucose levels are not satisfactorily controlled with the two medicines;
  • in combination with insulin, with or without metformin, in patients whose blood glucose levels are not satisfactorily controlled with a stable dose of insulin.

Sitagliptin SUN contains the active substance sitagliptin and is a ‘generic medicine’. This means that Sitagliptin SUN contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Januvia. For more information on generic medicines, see the question-and-answer document here.

This EPAR was last updated on 17/01/2022

Authorisation details

Product details
Name
Sitagliptin SUN
Agency product number
EMEA/H/C/005741
Active substance
sitagliptin fumarate
International non-proprietary name (INN) or common name
sitagliptin fumarate
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BH01
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Sun Pharmaceutical Industries Europe B.V.
Date of issue of marketing authorisation valid throughout the European Union
09/12/2021
Contact address

Polarisavenue 87
2132JH Hoofddorp
The Netherlands

Product information

Sitagliptin SUN - EMEA/H/C/005741 -

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

For adult patients with type 2 diabetes mellitus, Sitagliptin SUN is indicated to improve glycaemic control:

as monotherapy:
- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.

as dual oral therapy in combination with:
- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.
- a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.
- a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control.

as triple oral therapy in combination with:
- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
- a PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.

Sitagliptin SUN is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Assessment history

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