Lyrica
pregabalin
Table of contents
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.
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List item
Lyrica : EPAR - Summary for the public (PDF/62.06 KB)
First published: 18/08/2009
Last updated: 18/06/2010 -
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List item
Lyrica : EPAR - Risk-management-plan summary (PDF/216.63 KB)
First published: 17/12/2018
This EPAR was last updated on 19/06/2019
Authorisation details
Product details | |
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Name |
Lyrica
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Agency product number |
EMEA/H/C/000546
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Active substance |
pregabalin
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International non-proprietary name (INN) or common name |
pregabalin
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Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
N03AX16
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Publication details | |
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Marketing-authorisation holder |
Pfizer Europe MA EEIG
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Revision |
42
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Date of issue of marketing authorisation valid throughout the European Union |
05/07/2004
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Contact address |
Product information
21/05/2019 Lyrica - EMEA/H/C/000546 - N/0100
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
Pharmacotherapeutic group
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Anti epileptics
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other anti epileptics
Therapeutic indication
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.