Xultophy
insulin degludec / liraglutide
Table of contents
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.
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List item
Xultophy : EPAR - Medicine overview (PDF/83.69 KB)
First published: 21/11/2014
Last updated: 13/07/2018
EMA/462053/2014 -
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List item
Xultophy : EPAR - Risk-management-plan summary (PDF/68.8 KB)
First published: 21/11/2014
Last updated: 21/11/2014
EMA/467911/2014
Authorisation details
Product details | |
---|---|
Name |
Xultophy
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Agency product number |
EMEA/H/C/002647
|
Active substance |
|
International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
Diabetes Mellitus, Type 2
|
Anatomical therapeutic chemical (ATC) code |
A10
|
Publication details | |
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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 |
Product information
01/06/2023 Xultophy - EMEA/H/C/002647 - II/0049
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.