Trulicity
dulaglutide
Table of contents
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.
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List item
Trulicity : EPAR - Summary for the public (PDF/77.39 KB)
First published: 19/12/2014
Last updated: 19/12/2014
EMA/599496/2014 -
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List item
Trulicity : EPAR - Risk-management-plan summary (PDF/96.79 KB)
First published: 19/12/2014
Last updated: 08/11/2019
EMA/601943/2014
Authorisation details
Product details | |
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Name |
Trulicity
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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 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 | |
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Marketing-authorisation holder |
Eli Lilly Nederland B.V.
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Revision |
11
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Date of issue of marketing authorisation valid throughout the European Union |
21/11/2014
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Contact address |
Product information
21/10/2019 Trulicity - EMEA/H/C/002825 - II/0040
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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
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Drugs used in diabetes
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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.