Lyrica

pregabalin

Overview
Authorisation details
Product information
Assessment history

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.

: Lyrica is a medicine that contains the active substance pregabalin. It is available as capsules (white: 25, 50 and 150 mg; white and orange: 75, 225 and 300 mg; orange: 100 mg; light orange: 200 mg) and as an oral solution (20 mg/ml).

Lyrica is used to treat adults with the following conditions:

neuropathic pain (pain due to nerve damage). Lyrica can be used in peripheral neuropathic pain, such as the pain experienced by diabetic patients or by patients who have had herpes zoster (shingles), and central neuropathic pain, such as the pain experienced by patients who have had a spinal-cord injury;
epilepsy. Lyrica is used as an ‘add-on’ to existing treatment in patients who have partial seizures (epileptic fits starting in one specific part of the brain) that cannot be controlled with their current treatment;
generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).

The medicine can only be obtained with a prescription.

: The recommended starting dose of Lyrica is 150 mg per day, divided into two or three doses. After three to seven days, the dose can be increased to 300 mg per day. Doses can be increased up to twice more until the most effective dose is reached. The maximum dose is 600 mg per day. Stopping treatment with Lyrica should also be done gradually, over at least a week.
The capsules should be swallowed whole with water. Patients who have kidney problems need to take lower doses.

: The active substance in Lyrica, pregabalin, is similar in structure to the body’s own ‘neurotransmitter’ gamma-amino butyric acid (GABA), but has very different biological effects. Neurotransmitters are chemicals that allow nerve cells to communicate with each other. The exact way that pregabalin works is not fully understood, but it is thought to affect the way that calcium enters nerve cells. This reduces the activity of some of the nerve cells in the brain and spinal cord, reducing the release of other neurotransmitters that are involved in pain, epilepsy and anxiety.

Lyrica has been compared with placebo (a dummy treatment) in 22 studies:

for peripheral neuropathic pain, there were ten studies involving over 3,000 patients, about half of whom had diabetic neuropathy and half of whom had pain following shingles. A further study was carried out in 137 patients with central neuropathic pain due to a spinal-cord injury. The studies lasted up to 12 weeks. The effectiveness of Lyrica was measured using a standard pain questionnaire;
for epilepsy, there were three studies involving over 1,000 patients. The main measure of effectiveness was the change in the number of seizures after 11 to 12 weeks;
for generalised anxiety disorder, there were eight studies involving over 3,000 patients. Effectiveness was measured using a standard anxiety questionnaire after four to eight weeks.

: In neuropathic pain, Lyrica was more effective than placebo in decreasing pain. In peripheral neuropathic pain, 35% of the patients treated with Lyrica had a decrease in pain scores of 50% or more, compared with 18% of the patients treated with placebo. In central neuropathic pain, 22% of patients treated with Lyrica had a decrease in pain scores of 50% or more, compared with 8% of the patients treated with placebo.
In epilepsy, Lyrica reduced the number of seizures: about 45% of the patients taking 600 mg Lyrica a day and about 35% of those taking 300 mg Lyrica a day had a reduction in seizures of 50% or more. This compared with about 10% of the patients taking placebo.
In generalised anxiety disorder, Lyrica was more effective than placebo: 52% of the patients taking Lyrica had an improvement of 50% or more, compared with 38% of the patients taking placebo.

: The most common side effects with Lyrica (seen in more than 1 patient in 10) are dizziness and somnolence (sleepiness). For the full list of all side effects reported with Lyrica, see the package leaflet.
Lyrica should not be used in people who may be hypersensitive (allergic) to pregabalin or any of the other ingredients.

: The CHMP decided that Lyrica’s benefits are greater than its risks and recommended that it be given marketing authorisation.

: The European Commission granted a marketing authorisation valid throughout the European Union for Lyrica to Pfizer Limited on 6 July 2004. The marketing authorisation is valid for an unlimited period.
For more information about treatment with Lyrica, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

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Lyrica : EPAR - Summary for the public (PDF/62.06 KB)

First published: 18/08/2009
Last updated: 18/06/2010
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Lyrica : EPAR - Risk-management-plan summary (PDF/216.63 KB)

First published: 17/12/2018

More detail is available in the summary of product characteristics

This EPAR was last updated on 12/12/2019

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 Europe MA EEIG
Revision	43
Date of issue of marketing authorisation valid throughout the European Union	05/07/2004
Contact address	Boulevard de la Plaine 17 1050 Bruxelles Belgium

Product information

14/11/2019 Lyrica - EMEA/H/C/000546 - WS/1605

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Lyrica : EPAR - Product Information (PDF/754.63 KB)

First published: 23/09/2009
Last updated: 12/12/2019
- Bulgarian
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- Icelandic
  (PDF/1.56 MB)
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- Latvian
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- Lithuanian
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- Maltese
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- Norwegian
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- Romanian
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- Slovak
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- Slovenian
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- Spanish
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- Swedish
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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.

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Lyrica : EPAR - All Authorised presentations (PDF/48.79 KB)

First published: 23/08/2007
Last updated: 19/06/2019
- Bulgarian
  (PDF/41.45 KB)
- Croatian
  (PDF/39.48 KB)
- Czech
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- Danish
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- Dutch
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- Estonian
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- Finnish
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- French
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- German
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- Greek
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- Hungarian
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- Icelandic
  (PDF/38.76 KB)
- Italian
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- Latvian
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- Lithuanian
  (PDF/42.39 KB)
- Maltese
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- Norwegian
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- Polish
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- Portuguese
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- Slovak
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- Slovenian
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- Spanish
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- Swedish
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Pharmacotherapeutic group

Antiepileptics
Other antiepileptics

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

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Lyrica : EPAR - Procedural steps taken and scientific information after authorisation (PDF/276.04 KB)

First published: 23/09/2009
Last updated: 12/12/2019
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Lyrica-H-C-PSUSA-00002511-201601: EPAR - Scientific Conclusion (PDF/66.91 KB)

First published: 30/11/2016
Last updated: 30/11/2016
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Lyrica-H-C-546-P46-0051 : EPAR - Assessment Report (PDF/531.88 KB)

Adopted

First published: 15/03/2016
Last updated: 15/03/2016
EMA/200865/2016
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Lyrica-H-C-546-P46-0048 : EPAR - Assessment Report (PDF/697.34 KB)

Adopted

First published: 10/11/2015
Last updated: 10/11/2015
EMA/CHMP/520162/2015
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Lyrica-H-C-546-P46-0045 : EPAR - Assessment Report (PDF/1005.79 KB)

Adopted

First published: 17/11/2014
Last updated: 17/11/2014
EMA/620639/2014
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Lyrica-H-C-546-P45-0024 : EPAR - Assessment Report (PDF/161.28 KB)

Adopted

First published: 04/02/2013
Last updated: 04/02/2013
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Lyrica-H-C-546-II-0024 : EPAR - Refusal assessment report - Variation (PDF/472.86 KB)

First published: 11/08/2009
Last updated: 11/08/2009
EMEA/508570/2009
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Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Lyrica (PDF/41.55 KB)

Adopted

First published: 24/07/2009
Last updated: 24/07/2009
EMEA/464033/2009
- Bulgarian
  (PDF/179.22 KB)
- Czech
  (PDF/123.09 KB)
- Danish
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- Dutch
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- Estonian
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- Finnish
  (PDF/42.91 KB)
- French
  (PDF/38.79 KB)
- German
  (PDF/44.04 KB)
- Greek
  (PDF/177.95 KB)
- Hungarian
  (PDF/117.92 KB)
- Italian
  (PDF/42.96 KB)
- Latvian
  (PDF/146.22 KB)
- Lithuanian
  (PDF/122.67 KB)
- Maltese
  (PDF/153.21 KB)
- Polish
  (PDF/127.83 KB)
- Portuguese
  (PDF/44.13 KB)
- Romanian
  (PDF/120.39 KB)
- Slovak
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- Slovenian
  (PDF/116.69 KB)
- Spanish
  (PDF/43.79 KB)
- Swedish
  (PDF/43.47 KB)
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Lyrica-H-C-546-II-0007 : EPAR - Scientific Discussion - Variation (PDF/308.85 KB)

Adopted

First published: 18/01/2007
Last updated: 18/01/2007
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Lyrica-H-C-546-II-0004 : EPAR - Scientific Discussion - Variation (PDF/688.01 KB)

Adopted

First published: 13/09/2006
Last updated: 13/09/2006

Lyrica

Table of contents

Overview

Lyrica : EPAR - Summary for the public (PDF/62.06 KB)

Lyrica : EPAR - Risk-management-plan summary (PDF/216.63 KB)

Authorisation details

Product information

Lyrica : EPAR - Product Information (PDF/754.63 KB)

Contents

Lyrica : EPAR - All Authorised presentations (PDF/48.79 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Lyrica : EPAR - Procedural steps taken and scientific information after authorisation (PDF/276.04 KB)

Lyrica-H-C-PSUSA-00002511-201601: EPAR - Scientific Conclusion (PDF/66.91 KB)

Lyrica-H-C-546-P46-0051 : EPAR - Assessment Report (PDF/531.88 KB)

Lyrica-H-C-546-P46-0048 : EPAR - Assessment Report (PDF/697.34 KB)

Lyrica-H-C-546-P46-0045 : EPAR - Assessment Report (PDF/1005.79 KB)

Lyrica-H-C-546-P45-0024 : EPAR - Assessment Report (PDF/161.28 KB)

Lyrica-H-C-546-II-0024 : EPAR - Refusal assessment report - Variation (PDF/472.86 KB)

Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Lyrica (PDF/41.55 KB)

Lyrica-H-C-546-II-0007 : EPAR - Scientific Discussion - Variation (PDF/308.85 KB)

Lyrica-H-C-546-II-0004 : EPAR - Scientific Discussion - Variation (PDF/688.01 KB)

Initial marketing-authorisation documents

Lyrica : EPAR - Scientific Discussion (PDF/714.05 KB)

Lyrica : EPAR - Procedural steps taken before authorisation (PDF/81.38 KB)

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