EPARs human use - Efficib//sitagliptin / metformin hydrochloride

FICHA FARMACOLÓGICA de sitagliptin / metformin hydrochloride. Contiene la Monografía en distintos idiomas (de la Comunidad Económica Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Cerasale. MAYO 19, 2009.-

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EPARs for authorised medicinal products for human use - Efficib

Active Substance
sitagliptin / metformin hydrochloride
International Nonproprietary Name or Common Name
sitagliptin / metformin hydrochloride
Pharmaco-therapeutic Group
Combinations of oral blood glucose lowering drugs
ATC Code
A10BD07

Therapeutic Indication:
For patients with type 2 diabetes mellitus:
* Efficib 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.
** Efficib is also 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.

Date of issue of Marketing Authorisation valid throughout the European Union
16 July 2008