Cymbalta

RSS

duloxetine

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

Overview

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 22/02/2017

Authorisation details

Product details
Name
Cymbalta
Agency product number
EMEA/H/C/000572
Active substance
duloxetine
International non-proprietary name (INN) or common name
duloxetine
Therapeutic area (MeSH)
  • Anxiety Disorders
  • Diabetic Neuropathies
  • Depressive Disorder, Major
Anatomical therapeutic chemical (ATC) code
N06AX21
Publication details
Marketing-authorisation holder
Eli Lilly Nederland B.V.
Revision
25
Date of issue of marketing authorisation valid throughout the European Union
17/12/2004
Contact address

Papendorpseweg 83
3528 BJ Utrecht
Netherlands

Product information

26/01/2017 Cymbalta - EMEA/H/C/000572 - WS/1109

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

Psychoanaleptics

Therapeutic indication

Treatment of major depressive disorder.

Treatment of diabetic peripheral neuropathic pain.

Treatment of generalised anxiety disorder.

Cymbalta is indicated in adults.

Assessment history

Changes since initial authorisation of medicine

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