Vildagliptin & Metformin Tabs (50+850 mg), (50+1000 mg) (EU CTD Available: Q3 2021)
Description: Vildagliptin & Metformin is a combination of 2 anti-diabetic agents indicated in the treatment of type 2 diabetes mellitus. More specifically, it is indicated:- In the treatment of adult patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets.- In combination with a sulphonylurea or insulin as an adjunct to diet and exercise in adult patients inadequately controlled with metformin and a sulphonylurea or insulin. Dossier Status: On-going
Stability Studies: Zone II / Zone IVb
Shelf life (Originator): Two (2) years (PA/Alu/PVC/Alu ) or 18 months (PCTFE/PVC/Alu)
Batch Sizes: 100.000 tablets (commercial up to 1.000.000 tablets)
Pack Sizes: To be defined / Originator pack: Box x 10, 30, 60, 120, 180 & 360 tablets
|Categories||Pharmaceutical Products / ATC coding | Alimentary Tract and MetabolismOther Alimentary Tract and Metabolism Products; Finished Dosage FormsOut-licensing; Finished Dosage FormsTablets|
|Sales markets||Middle East Region (e.g. UAE); Oceania; North America (USA, Canada); Africa; Central America (e.g. Mexico); Europe - EU countries; Europe - non EU (e.g. UK, Russia, ex-CIS countries); South America (e.g. Brazil, Colombia); South East Asia (e.g. Thailand, Philippines, Singapore)|
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