Xeristar

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) for Xeristar. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Xeristar.

This EPAR was last updated on 08/10/2019

Authorisation details

Product details
Name
Xeristar
Agency product number
EMEA/H/C/000573
Active substance
duloxetine
International non-proprietary name (INN) or common name
duloxetine
Therapeutic area (MeSH)
  • Anxiety Disorders
  • Depressive Disorder, Major
  • Diabetic Neuropathies
Anatomical therapeutic chemical (ATC) code
N06AX21
Publication details
Marketing-authorisation holder
Eli Lilly Nederland B.V.
Revision
28
Date of issue of marketing authorisation valid throughout the European Union
17/12/2004
Contact address
Grootslag 1-5
NL-3991 RA Houten
The Netherlands

Product information

25/07/2019 Xeristar - EMEA/H/C/000573 - WS/1527/G

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;
  • Xeristar is indicated in adults.

Assessment history

Changes since initial authorisation of medicine

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