Basic Information
EMA regulatory identification and product classification information
EMA Identifiers
Special Designations
EMA special regulatory designations and classifications
Overview Summary
Comprehensive product overview and regulatory summary
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.
Active Substances (1)
sitagliptin fumarate
Documents (10)
Sitagliptin SUN : EPAR - Public assessment report
January 17, 2022
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
CHMP summary of opinion for Sitagliptin SUN
October 14, 2021
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
CHMP summary of opinion for Sitagliptin SUN
October 14, 2021
CHANGES_SINCE_INITIAL_AUTHORISATION
Sitagliptin SUN : EPAR - Procedural steps taken and scientific information after authorisation (archive)
October 27, 2022
CHANGES_SINCE_INITIAL_AUTHORISATION
Sitagliptin SUN : EPAR - Public assessment report
January 17, 2022
CHANGES_SINCE_INITIAL_AUTHORISATION
Sitagliptin SUN : EPAR - Procedural steps taken and scientific information after authorisation
February 26, 2025
CHANGES_SINCE_INITIAL_AUTHORISATION
Sitagliptin SUN : EPAR - All authorised presentations
January 17, 2022
AUTHORISED_PRESENTATIONS
Sitagliptin SUN : EPAR - Risk management plan summary
January 17, 2022
RISK_MANAGEMENT_PLAN_SUMMARY
Sitagliptin SUN : EPAR - Product Information
January 17, 2022
DRUG_PRODUCT_INFORMATION
Sitagliptin SUN : EPAR - Medicine overview
January 17, 2022
OVERVIEW_DOCUMENT
Overview Q&A (7)
Question
How is Sitagliptin SUN used?
Answer
Sitagliptin SUN is available as tablets and can only be obtained with a prescription. The recommended dose is 100 mg once a day. The dose may be lowered in some patients with reduced kidney function. If Sitagliptin SUN is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered to reduce the risk of hypoglycaemia (low blood glucose levels).
For more information about using Sitagliptin SUN, see the package leaflet or contact your doctor or pharmacist.
Question
How does Sitagliptin SUN work?
Answer
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. The active substance in Sitagliptin SUN, sitagliptin, is a dipeptidyl-peptidase-4 (DPP-4) inhibitor. It works by blocking the breakdown of ‘incretin’ hormones in the body. These hormones are released after a meal and stimulate the pancreas to produce insulin. By increasing levels of incretin hormones in the blood, sitagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. Sitagliptin does not work when blood glucose levels are low. Sitagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon. Together, these processes reduce blood glucose levels and help to control type 2 diabetes.
Question
Why is Sitagliptin SUN authorised in the EU?
Answer
The European Medicines Agency concluded that, in accordance with EU requirements, Sitagliptin SUN has been shown to have comparable quality and to be bioequivalent to Januvia. Therefore, the Agency’s view was that, as for Januvia, the benefits of Sitagliptin SUN outweigh the identified risks and it can be authorised for use in the EU.
Question
What measures are being taken to ensure the safe and effective use of Sitagliptin SUN?
Answer
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sitagliptin SUN have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Sitagliptin SUN are continuously monitored. Suspected side effects reported with Sitagliptin SUN are carefully evaluated and any necessary action taken to protect patients.
Question
Other information about Sitagliptin SUN
Answer
Sitagliptin SUN received a marketing authorisation valid throughout the EU on 09 December 2021.
Question
What are the benefits and risks of Sitagliptin SUN?
Answer
Because Sitagliptin SUN is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
Question
How has Sitagliptin SUN been studied?
Answer
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Januvia, and do not need to be repeated for Sitagliptin SUN.
As for every medicine, the company provided data on the quality of Sitagliptin SUN. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.