Duloxetine Zentiva

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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 Zentiva. 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 Zentiva.

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

This EPAR was last updated on 31/05/2017

Authorisation details

Product details
Name
Duloxetine Zentiva
Agency product number
EMEA/H/C/003935
Active substance
duloxetine
International non-proprietary name (INN) or common name
duloxetine
Therapeutic area (MeSH)
  • Anxiety Disorders
  • Depressive Disorder, Major
  • Neuralgia
  • Diabetes Mellitus
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
Zentiva, k.s.
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
20/08/2015
Contact address
U kabelovny
130 Dolni Mecholupy
102 37 Praha 10
Czech Republic

Product information

17/05/2017 Duloxetine Zentiva - EMEA/H/C/003935 - IB/0002

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

  • Gastro resistant capsule
  • hard

Therapeutic indication

Treatment depressive disorder, diabetic neuropathic pain, anxiety disorder.

Duloxetine Zentiva is indicated in adults.

Assessment history

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