Sitagliptin Accord
sitagliptin
Table of contents
Overview
Sitagliptin Accord 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 type of 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 Accord contains the active substance sitagliptin and is a ‘generic medicine’. This means that Sitagliptin Accord 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.
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Sitagliptin Accord : EPAR - Medicine overview (PDF/170.63 KB)
First published: 05/07/2022
EMEA/H/C/005598 -
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Sitagliptin Accord : EPAR - Risk management plan summary (PDF/124.49 KB)
First published: 05/07/2022
Authorisation details
| Product details | |
|---|---|
| Name |
Sitagliptin Accord
|
| Agency product number |
EMEA/H/C/005598
|
| Active substance |
sitagliptin hydrochloride
|
| International non-proprietary name (INN) or common name |
sitagliptin
|
| Therapeutic area (MeSH) |
Diabetes Mellitus, Type 2
|
| Anatomical therapeutic chemical (ATC) code |
A10BH01
|
Generic |
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 |
Accord Healthcare S.L.U.
|
| Date of issue of marketing authorisation valid throughout the European Union |
25/04/2022
|
| Contact address |
Accord Healthcare S.L.U. |
Product information
25/04/2022 Sitagliptin Accord - EMEA/H/C/005598 -
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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 Accord 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 (PPARy) agonist (i.e. a thiazolidinedione) when use of a PPARy agonist is appropriate and when diet and exercise plus the PPARy 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 PPARy agonist and metformin when use of a PPARy agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
Sitagliptin Accord 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.