sitagliptin phosphate monohydrate - EPARs human use - TESAVEL

FICHA FARMACOLÓGICA de sitagliptin phosphate monohydrate 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. OCTUBRE 10, 2009.

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EPARs for authorised medicinal products for human use - TESAVEL

Active Substance
sitagliptin phosphate monohydrate
International Nonproprietary Name or Common Name
sitagliptin
Pharmaco-therapeutic Group
DPP-4 inhibitor
ATC Code
A10BH01

Therapeutic Indication:
For patients with type 2 diabetes mellitus, TESAVEL is indicated:

- to improve glycaemic control when diet and exercise alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.

- to improve glycaemic control in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.

- to improve glycaemic control in combination with 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.

- to improve glycaemic control in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control.

For patients with type 2 diabetes mellitus in whom use of a PPARγ agonist (i.e. a thiazolidinedione) is appropriate, TESAVEL is indicated:

- in combination with the PPARγ agonist when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control.

- in combination with the PPARγ agonist and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control.

Date of issue of Marketing Authorisation valid throughout the European Union
10 January 2008

Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use