sitagliptin / metformin hydrochloride - EPARs human use - Efficib

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. Se recuerda que todas las informaciones científico-clínicas, así como técnicas propias de la producción, sólo se publican en idioma inglés. Cerasale. SEPTIEMBRE 28, 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 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.

Efficib is also indicated as triple combination therapy with a PPARγ 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 PPARγ agonist.

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

Orphan medicinal product designation date
Not applicable

EPARs for authorised medicinal products for human use