About this document
Daltex 50/850 & 50/1000 Approval Report by umar is a document available to read on EtoBox.
This document summarizes the scientific discussion for approval of Daltex, a film-coated tablet containing vildagliptin and metformin hydrochloride. Bioequivalence studies showed Daltex to be bioequivalent to the reference product Eucreas. Based on the established quality, safety and efficacy of vildagliptin and metformin, marketing authorization was granted for Daltex by Member States for the treatment of type 2 diabetes mellitus. No additional safety concerns were identified beyond those for the reference
- Author
- umar
- Language
- EN