Duloxetine Zentiva



This medicine is authorised for use in the European Union.


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 16/08/2022

Authorisation details

Product details
Duloxetine Zentiva
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Neuralgia
  • Depressive Disorder, Major
  • Anxiety Disorders
  • Diabetes Mellitus
Anatomical therapeutic chemical (ATC) code

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
Zentiva, k.s.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

U kabelovny
130 Dolni Mecholupy
102 37 Praha 10
Czech Republic

Product information

12/08/2022 Duloxetine Zentiva - EMEA/H/C/003935 - IB/0015/G

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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

Other antidepressants

Therapeutic indication

Treatment depressive disorder, diabetic neuropathic pain, anxiety disorder.

Duloxetine Zentiva is indicated in adults.

Assessment history

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