Galvus

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vildagliptin

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Galvus. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Galvus.

This EPAR was last updated on 12/11/2018

Authorisation details

Product details
Name
Galvus
Agency product number
EMEA/H/C/000771
Active substance
vildagliptin
International non-proprietary name (INN) or common name
vildagliptin
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BH02
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
16
Date of issue of marketing authorisation valid throughout the European Union
25/09/2007
Contact address

Elm Park, Merrion Road
Dublin 4
Ireland

Product information

25/04/2018 Galvus - EMEA/H/C/000771 - T/0055

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Vildagliptin is indicated in the treatment of type-2 diabetes mellitus in adults:

as monotherapy:

  • in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance;

as dual oral therapy in combination with:

  • metformin, in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin;
  • a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of a sulphonylurea and for whom metformin is inappropriate due to contraindications or intolerance;
  • a thiazolidinedione, in patients with insufficient glycaemic control and for whom the use of a thiazolidinedione is appropriate;

as triple oral therapy in combination with:

  • a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.

Vildagliptin is also indicated for use in combination with insulin (with or without metformin) when diet and exercise plus a stable dose of insulin do not provide adequate glycaemic control.

Assessment history

Changes since initial authorisation of medicine

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