Xelevia (sitagliptin)
- Region
- 🇪🇺 EU
- Active substance
- sitagliptin
- Company
- Merck Sharp & Dohme B.V.
- Status
- Authorised
- Therapeutic area
- Diabetes Mellitus, Type 2
- CHMP opinion
- Tue 14 Nov 2023
- EU approval
- Wed 21 Mar 2007
- Application
- EMEA/H/C/000762
- ATC
- A10BH01
- Official record
- www.ema.europa.eu
Indication
For adult patients with type-2 diabetes mellitus, Xelevia 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 (PPAR?) agonist (i.e. a thiazolidinedione) when use of a PPAR? agonist is appropriate and when diet and exercise plus the PPAR? 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 PPAR? agonist and metformin when use of a PPAR? agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Xelevia 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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
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- 🇪🇺 Sitagliptin / Metformin hydrochloride Accord Lapsed · Accord Healthcare S.L.U.
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- 🇪🇺 Ristaben Authorised · Merck Sharp & Dohme B.V.
- 🇪🇺 Sitagliptin / Metformin hydrochloride Sun Authorised · Sun Pharmaceutical Industries Europe B.V.
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