Xultophy

RSS

insulin degludec / liraglutide

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

Overview

An overview of Xultophy and why it is authorised in the EU

Xultophy is a medicine that is used for the treatment of type 2 diabetes. Together with diet and exercise, Xultophy is added to treatment with diabetes medicines taken by mouth when these medicines, alone or with other injections, have not controlled blood glucose (sugar) levels.

The active substances in Xultophy are insulin degludec and liraglutide.

This EPAR was last updated on 13/07/2018

Authorisation details

Product details
Name
Xultophy
Agency product number
EMEA/H/C/002647
Active substance
  • insulin degludec
  • liraglutide
International non-proprietary name (INN) or common name
insulin degludec / liraglutide
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Novo Nordisk A/S
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
18/09/2014
Contact address
Novo Alle
Bagsværd - 2880
Denmark

Product information

07/06/2018 Xultophy - EMEA/H/C/002647 - II/0023

Contents

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

Xultophy is indicated for the treatment of adults with type-2 diabetes mellitus to improve glycaemic control in combination with oral glucose-lowering medicinal products when these alone or combined with a GLP-1 receptor agonist or basal insulin do not provide adequate glycaemic control.

Assessment history

Changes since initial authorisation of medicine

How useful was this page?

Add your rating
Average
1 rating