EPARs human use - Janumet//sitagliptin phosphate monohydrate / metformin hydrochloride

FICHA FARMACOLÓGICA de sitagliptin phosphate monohydrate / 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. AGOSTO 17, 2009.-

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EPARs for authorised medicinal products for human use - Janumet

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

Therapeutic Indication:
For patients with type 2 diabetes mellitus:

Janumet 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.

Janumet 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.

Janumet is also indicated as triple combination therapy with a PPAR 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 PPAR agonist.

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

Orphan medicinal product designation date
Not applicable