Trulicity

RSS

dulaglutide

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

Overview

This is a summary of the European public assessment report (EPAR) for Trulicity. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Trulicity.

For practical information about using Trulicity, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 08/11/2019

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
Additional monitoringAdditional 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
Eli Lilly Nederland B.V.
Revision
11
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

21/10/2019 Trulicity - EMEA/H/C/002825 - II/0040

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

  • other blood glucose lowering drugs
  • excl. insulins

Therapeutic indication

Trulicity is indicated for the treatment of adults 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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