Duloxetine Mylan

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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 Duloxetine Mylan. 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 Mylan.

For practical information about using Duloxetine Mylan, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 05/09/2018

Authorisation details

Product details
Name
Duloxetine Mylan
Agency product number
EMEA/H/C/003981
Active substance
duloxetine
International non-proprietary name (INN) or common name
duloxetine
Therapeutic area (MeSH)
  • Neuralgia
  • Diabetic Neuropathies
  • Anxiety Disorders
  • Depressive Disorder, Major
Anatomical therapeutic chemical (ATC) code
N06AX21
Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic medicines.

Publication details
Marketing-authorisation holder
Mylan S.A.S.
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
19/06/2015
Contact address
117 Allée des Parcs
69800 Saint Priest
France

Product information

03/08/2018 Duloxetine Mylan - EMEA/H/C/003981 - T/0014

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;
  • Duloxetine Myl++an is indicated in adults.

For further information see section 5.1.

Assessment history

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