Pregabalin Accord

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pregabalin

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Pregabalin Accord. 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 Pregabalin Accord.

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

This EPAR was last updated on 09/01/2023

Authorisation details

Product details
Name
Pregabalin Accord
Agency product number
EMEA/H/C/004024
Active substance
pregabalin
International non-proprietary name (INN) or common name
pregabalin
Therapeutic area (MeSH)
  • Anxiety Disorders
  • Epilepsy
Anatomical therapeutic chemical (ATC) code
N03AX16
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
Accord Healthcare S.L.U.
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
28/08/2015
Contact address

World Trade Center
Moll de Barcelona
s/n, Edifici Est 6ª planta
08039 Barcelona
Spain

Product information

09/01/2023 Pregabalin Accord - EMEA/H/C/004024 - IB/0034/G

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

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

Antiepileptics

Therapeutic indication

Epilepsy

  • Pregabalin Accord is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

Generalised Anxiety Disorder

  • Pregabalin Accord is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.

Assessment history

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