Duloxetine Lilly
duloxetine
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Duloxetine Lilly. 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 Duloxetine Lilly.
For practical information about using Duloxetine Lilly, patients should read the package leaflet or contact their doctor or pharmacist.
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List item
Duloxetine Lilly : EPAR - Summary for the public (PDF/126.1 KB)
First published: 26/01/2015
Last updated: 26/01/2015
EMA/664208/2014 -
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Duloxetine Lilly : EPAR - Risk-management-plan summary (PDF/2.02 MB)
First published: 26/01/2015
Last updated: 22/09/2020
Authorisation details
Product details | |
---|---|
Name |
Duloxetine Lilly
|
Agency product number |
EMEA/H/C/004000
|
Active substance |
duloxetine
|
International non-proprietary name (INN) or common name |
duloxetine
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
N06AX21
|
Publication details | |
---|---|
Marketing-authorisation holder |
Eli Lilly Nederland B.V.
|
Revision |
9
|
Date of issue of marketing authorisation valid throughout the European Union |
08/12/2014
|
Contact address |
Papendorpseweg 83 |
Product information
15/12/2021 Duloxetine Lilly - EMEA/H/C/004000 - N/0024
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
Psychoanaleptics
Therapeutic indication
Duloxetine Lilly is indicated in adults for:
- Treatment of major depressive disorder
- Treatment of diabetic peripheral neuropathic pain
- Treatment of generalised anxiety disorder
Duloxetine Lilly is indicated in adults.