Pregabalin Pfizer

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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 Pfizer. 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 Pfizer.

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

This EPAR was last updated on 20/03/2023

Authorisation details

Product details
Name
Pregabalin Pfizer
Agency product number
EMEA/H/C/003880
Active substance
pregabalin
International non-proprietary name (INN) or common name
pregabalin
Therapeutic area (MeSH)
  • Anxiety Disorders
  • Epilepsy
Anatomical therapeutic chemical (ATC) code
N03AX16
Publication details
Marketing-authorisation holder
Upjohn EESV
Revision
29
Date of issue of marketing authorisation valid throughout the European Union
10/04/2014
Contact address

Rivium Westlaan 142 
Capelle aan den Ijssel
2909 LD
Netherlands

Product information

14/03/2023 Pregabalin Pfizer - EMEA/H/C/003880 - N/0050

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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

Neuropathic pain

  • Pregabalin Pfizer is indicated for the treatment of peripheral and central neuropathic pain in adults.

Epilepsy

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

Generalised Anxiety Disorder

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

Assessment history

Changes since initial authorisation of medicine

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