Lyrica

RSS

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 Lyrica. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Lyrica.

This EPAR was last updated on 12/01/2018

Authorisation details

Product details
Name
Lyrica
Agency product number
EMEA/H/C/000546
Active substance
pregabalin
International non-proprietary name (INN) or common name
pregabalin
Therapeutic area (MeSH)
  • Epilepsy
  • Anxiety Disorders
  • Neuralgia
Anatomical therapeutic chemical (ATC) code
N03AX16
Publication details
Marketing-authorisation holder
Pfizer Limited
Revision
38
Date of issue of marketing authorisation valid throughout the European Union
06/07/2004
Contact address
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom

Product information

16/11/2017 Lyrica - EMEA/H/C/000546 - WS/1137

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

  • Anti epileptics
  • other anti epileptics

Therapeutic indication

Neuropathic pain

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

Epilepsy

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

Generalised anxiety disorder

  • Lyrica is indicated for the treatment of generalised anxiety disorder (GAD) in adults.

Assessment history

Changes since initial authorisation of medicine

How useful was this page?

Add your rating
Average
1 rating