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 25/04/2022

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
  • Depressive Disorder, Major
  • Anxiety Disorders
Anatomical therapeutic chemical (ATC) code
N06AX21
GenericGeneric

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 and hybrid medicines.

Publication details
Marketing-authorisation holder
Mylan Pharmaceuticals Limited
Revision
17
Date of issue of marketing authorisation valid throughout the European Union
19/06/2015
Contact address

Mylan Pharmaceuticals Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
Ireland

Product information

22/04/2022 Duloxetine Mylan - EMEA/H/C/003981 - N/0030

Product information documents contain:

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

  • Treatment of major depressive disorder;
  • Treatment of diabetic peripheral neuropathic pain;
  • Treatment of generalised anxiety disorder;
  • Duloxetine Mylan is indicated in adults.

Assessment history

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