Trulicity

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dulaglutide

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

Overview

Trulicity is a medicine used in adults and children from 10 years of age with type 2 diabetes. It is used in addition to appropriate diet and exercise.

Trulicity is used:

- on its own when use of metformin (another medicine for type 2 diabetes) is not recommended;

- as an ‘add-on’ to other diabetes medicines.

Trulicity contains the active substance dulaglutide.

This EPAR was last updated on 16/03/2023

Authorisation details

Product details
Name
Trulicity
Agency product number
EMEA/H/C/002825
Active substance
dulaglutide
International non-proprietary name (INN) or common name
dulaglutide
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BJ05
Publication details
Marketing-authorisation holder
Eli Lilly Nederland B.V.
Revision
17
Date of issue of marketing authorisation valid throughout the European Union
21/11/2014
Contact address

Papendorpseweg 83
3528 BJ Utrecht
The Netherlands

Product information

06/03/2023 Trulicity - EMEA/H/C/002825 - II/0065

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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

  • Blood glucose lowering drugs, excl. insulins

Therapeutic indication

Trulicity is indicated for the treatment of patients 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise

  • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
  • in addition to other medicinal products for the treatment of diabetes.

For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.

Assessment history

Changes since initial authorisation of medicine

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