Trulicity
dulaglutide
Table of contents
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.
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List item
Trulicity : EPAR - Medicine overview (PDF/106.03 KB)
First published: 19/12/2014
Last updated: 16/03/2023
EMA/61283/2023 -
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List item
Trulicity : EPAR - Risk-management-plan summary (PDF/210.22 KB)
First published: 19/12/2014
Last updated: 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 |
Product information
06/03/2023 Trulicity - EMEA/H/C/002825 - II/0065
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
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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 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
News
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11/07/2023
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 202327/01/2023
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20/09/2019
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26/09/2014