Xultophy

RSS

insulin degludec / liraglutide

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

Overview

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 25/08/2023

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
Publication details
Marketing-authorisation holder
Novo Nordisk A/S
Revision
16
Date of issue of marketing authorisation valid throughout the European Union
18/09/2014
Contact address

Novo Alle
Bagsværd - 2880
Denmark

Product information

01/06/2023 Xultophy - EMEA/H/C/002647 - II/0049

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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

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