Sitagliptin / Metformin hydrochloride Mylan

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sitagliptin hydrochloride monohydrate / metformin hydrochloride

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

Overview

Sitagliptin/Metformin hydrochloride Mylan 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:
• in patients whose blood glucose levels are not satisfactorily controlled with metformin (a diabetes medicine) used on its own;
• in patients who are already taking a combination of sitagliptin and metformin as separate tablets;
• in combination with a sulphonylurea, a PPAR-gamma agonist such as a thiazolidinedione, or insulin (other types of diabetes medicines) in patients whose blood glucose levels are not satisfactorily controlled with either of these medicines and metformin.
Sitagliptin/Metformin hydrochloride Mylan contains the active substances sitagliptin and metformin hydrochloride and is a ‘generic medicine’. This means that Sitagliptin/Metformin hydrochloride Mylan contains the same active substances and works in the same way as a ‘reference medicine’ already authorised in the EU called Janumet. For more information on generic medicines, see the question-and-answer document here.

This EPAR was last updated on 21/06/2022

Authorisation details

Product details
Name
Sitagliptin / Metformin hydrochloride Mylan
Agency product number
EMEA/H/C/005678
Active substance
  • sitagliptin hydrochloride monohydrate
  • metformin hydrochloride
International non-proprietary name (INN) or common name
  • sitagliptin hydrochloride monohydrate
  • metformin hydrochloride
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BD07
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
Mylan Ireland Limited
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
16/02/2022
Contact address

Unit 35/36 Grange Parade
Baldoyle Industrial Estate
Dublin 13
Ireland

Product information

20/06/2022 Sitagliptin / Metformin hydrochloride Mylan - EMEA/H/C/005678 - IAIN/0003/G

Other EU languages available icon 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:

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/Metformin hydrochloride Mylan is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.

Sitagliptin/Metformin hydrochloride Mylan is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.

Sitagliptin/Metformin hydrochloride Mylan is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPARg) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARg agonist.

Sitagliptin/Metformin hydrochloride Mylan is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Assessment history

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