Pregabalin Accord

pregabalin

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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.

What is Pregabalin Accord and what is it used for?

Pregabalin Accord is a medicine used to treat adults with the following conditions:

  • neuropathic pain (pain due to nerve damage), including peripheral neuropathic pain, such as the pain experienced by patients with diabetes or herpes zoster (shingles), and central neuropathic pain, such as the pain experienced by patients who have had a spinal cord injury;
  • epilepsy, where it is used as an ‘add-on’ to other epilepsy treatment in patients who have partial seizures (epileptic fits starting in one specific part of the brain);
  • generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).

Pregabalin Accord contains the active substance pregabalin.

Pregabalin Accord is a ‘generic medicine’. This means that Pregabalin Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the European Union (EU) called Lyrica.

How is Pregabalin Accord used?

Pregabalin Accord is available as capsules (25, 50, 75, 100, 150, 200, 225 and 300 mg) and can only be obtained with a prescription. The recommended starting dose is 150 mg per day, divided into two or three doses. After one week, the dose can be increased to 300 mg per day. Doses can be increased further until the most effective dose is reached. The maximum dose is 600 mg per day. To stop treatment with Pregabalin Accord, the dose should be reduced gradually, over at least a week. Patients who have kidney problems may need to take lower doses.

How does Pregabalin Accord work?

The active substance in Pregabalin Accord, pregabalin, is similar in structure to the body’s own ‘neurotransmitter’ gamma‚ÄĎamino butyric acid (GABA), but has very different biological effects. Neurotransmitters are chemicals that allow nerve cells to communicate with each other. The exact way in which 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 epilepsy and anxiety.

How has Pregabalin Accord been studied?

Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Lyrica, and do not need to be repeated for Pregabalin Accord.

As for every medicine, the company provided studies on the quality of Pregabalin Accord. The company also carried out studies that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Pregabalin Accord?

Because Pregabalin Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why is Pregabalin Accord approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pregabalin Accord has been shown to have comparable quality and to be bioequivalent to Lyrica. Therefore, the CHMP’s view was that, as for Lyrica, the benefit outweighs the identified risk. The Committee recommended that Pregabalin Accord be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Pregabalin Accord?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pregabalin Accord have been included in the summary of product characteristics and the package leaflet.

Further information can be found in the summary of the risk management plan.

Other information about Pregabalin Accord

The European Commission granted a marketing authorisation valid throughout the European Union for Pregabalin Accord on 28 August 2015.

For more information about treatment with Pregabalin Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Pregabalin Accord : EPAR - Summary for the public BG = bălgarski 2015-09-18 2017-07-06
Pregabalin Accord : EPAR - Summary for the public ES = español 2015-09-18 2017-07-06
Pregabalin Accord : EPAR - Summary for the public CS = čeština 2015-09-18 2017-07-06
Pregabalin Accord : EPAR - Summary for the public DA = dansk 2015-09-18 2017-07-06
Pregabalin Accord : EPAR - Summary for the public DE = Deutsch 2015-09-18 2017-07-06
Pregabalin Accord : EPAR - Summary for the public ET = eesti keel 2015-09-18 2017-07-06
Pregabalin Accord : EPAR - Summary for the public EL = elliniká 2015-09-18 2017-07-06
Pregabalin Accord : EPAR - Summary for the public EN = English 2015-09-18 2017-07-06
Pregabalin Accord : EPAR - Summary for the public FR = français 2015-09-18 2017-07-06
Pregabalin Accord : EPAR - Summary for the public IT = italiano 2015-09-18 2017-07-06
Pregabalin Accord : EPAR - Summary for the public LV = latviešu valoda 2015-09-18 2017-07-06
Pregabalin Accord : EPAR - Summary for the public LT = lietuvių kalba 2015-09-18 2017-07-06
Pregabalin Accord : EPAR - Summary for the public HU = magyar 2015-09-18 2017-07-06
Pregabalin Accord : EPAR - Summary for the public MT = Malti 2015-09-18 2017-07-06
Pregabalin Accord : EPAR - Summary for the public NL = Nederlands 2015-09-18 2017-07-06
Pregabalin Accord : EPAR - Summary for the public PL = polski 2015-09-18 2017-07-06
Pregabalin Accord : EPAR - Summary for the public PT = português 2015-09-18 2017-07-06
Pregabalin Accord : EPAR - Summary for the public RO = română 2015-09-18 2017-07-06
Pregabalin Accord : EPAR - Summary for the public SK = slovenčina 2015-09-18 2017-07-06
Pregabalin Accord : EPAR - Summary for the public SL = slovenščina 2015-09-18 2017-07-06
Pregabalin Accord : EPAR - Summary for the public FI = suomi 2015-09-18 2017-07-06
Pregabalin Accord : EPAR - Summary for the public SV = svenska 2015-09-18 2017-07-06
Pregabalin Accord : EPAR - Summary for the public HR = Hrvatski 2015-09-18 2017-07-06
Name Language First published Last updated
Pregabalin Accord : EPAR - Risk-management-plan summary (English only) 2015-09-18  

This EPAR was last updated on 07/03/2018 .

Authorisation details

Product details

Product details for Pregabalin Accord
NamePregabalin Accord
Agency product numberEMEA/H/C/004024
Active substance

pregabalin

International non-proprietary name (INN) or common name

pregabalin

Therapeutic area EpilepsyAnxiety Disorders
Anatomical therapeutic chemical (ATC) code N03AX16
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Pregabalin Accord
Marketing-authorisation holder

Accord Healthcare Limited

Revision5
Date of issue of marketing authorisation valid throughout the European Union28/08/2015

Contact address:

Accord Healthcare Limited
Sage House 
319 Pinner Road 
North Harrow 
HA1 4HF 
United Kingdom

Product information

Product information

05/02/2018  Pregabalin Accord -EMEA/H/C/004024 -IB/0007

Name Language First published Last updated
Pregabalin Accord : EPAR - Product Information EN = English 2015-09-18 2018-03-07
Pregabalin Accord : EPAR - Product Information EN = English 2015-09-18 2018-03-07
Pregabalin Accord : EPAR - Product Information EN = English 2015-09-18 2018-03-07
Pregabalin Accord : EPAR - Product Information EN = English 2015-09-18 2018-03-07
Pregabalin Accord : EPAR - Product Information EN = English 2015-09-18 2018-03-07
Pregabalin Accord : EPAR - Product Information EN = English 2015-09-18 2018-03-07
Pregabalin Accord : EPAR - Product Information EN = English 2015-09-18 2018-03-07
Pregabalin Accord : EPAR - Product Information EN = English 2015-09-18 2018-03-07
Pregabalin Accord : EPAR - Product Information EN = English 2015-09-18 2018-03-07
Pregabalin Accord : EPAR - Product Information EN = English 2015-09-18 2018-03-07
Pregabalin Accord : EPAR - Product Information EN = English 2015-09-18 2018-03-07
Pregabalin Accord : EPAR - Product Information EN = English 2015-09-18 2018-03-07
Pregabalin Accord : EPAR - Product Information EN = English 2015-09-18 2018-03-07
Pregabalin Accord : EPAR - Product Information EN = English 2015-09-18 2018-03-07
Pregabalin Accord : EPAR - Product Information EN = English 2015-09-18 2018-03-07
Pregabalin Accord : EPAR - Product Information EN = English 2015-09-18 2018-03-07
Pregabalin Accord : EPAR - Product Information EN = English 2015-09-18 2018-03-07
Pregabalin Accord : EPAR - Product Information EN = English 2015-09-18 2018-03-07
Pregabalin Accord : EPAR - Product Information EN = English 2015-09-18 2018-03-07
Pregabalin Accord : EPAR - Product Information EN = English 2015-09-18 2018-03-07
Pregabalin Accord : EPAR - Product Information EN = English 2015-09-18 2018-03-07
Pregabalin Accord : EPAR - Product Information EN = English 2015-09-18 2018-03-07
Pregabalin Accord : EPAR - Product Information EN = English 2015-09-18 2018-03-07
Pregabalin Accord : EPAR - Product Information EN = English 2015-09-18 2018-03-07
Pregabalin Accord : EPAR - Product Information EN = English 2015-09-18 2018-03-07

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.


Name Language First published Last updated
Pregabalin Accord : EPAR - All Authorised presentations EN = English 2015-09-18 2016-02-22
Pregabalin Accord : EPAR - All Authorised presentations EN = English 2015-09-18 2016-02-22
Pregabalin Accord : EPAR - All Authorised presentations EN = English 2015-09-18 2016-02-22
Pregabalin Accord : EPAR - All Authorised presentations EN = English 2015-09-18 2016-02-22
Pregabalin Accord : EPAR - All Authorised presentations EN = English 2015-09-18 2016-02-22
Pregabalin Accord : EPAR - All Authorised presentations EN = English 2015-09-18 2016-02-22
Pregabalin Accord : EPAR - All Authorised presentations EN = English 2015-09-18 2016-02-22
Pregabalin Accord : EPAR - All Authorised presentations EN = English 2015-09-18 2016-02-22
Pregabalin Accord : EPAR - All Authorised presentations EN = English 2015-09-18 2016-02-22
Pregabalin Accord : EPAR - All Authorised presentations EN = English 2015-09-18 2016-02-22
Pregabalin Accord : EPAR - All Authorised presentations EN = English 2015-09-18 2016-02-22
Pregabalin Accord : EPAR - All Authorised presentations EN = English 2015-09-18 2016-02-22
Pregabalin Accord : EPAR - All Authorised presentations EN = English 2015-09-18 2016-02-22
Pregabalin Accord : EPAR - All Authorised presentations EN = English 2015-09-18 2016-02-22
Pregabalin Accord : EPAR - All Authorised presentations EN = English 2015-09-18 2016-02-22
Pregabalin Accord : EPAR - All Authorised presentations EN = English 2015-09-18 2016-02-22
Pregabalin Accord : EPAR - All Authorised presentations EN = English 2015-09-18 2016-02-22
Pregabalin Accord : EPAR - All Authorised presentations EN = English 2015-09-18 2016-02-22
Pregabalin Accord : EPAR - All Authorised presentations EN = English 2015-09-18 2016-02-22
Pregabalin Accord : EPAR - All Authorised presentations EN = English 2015-09-18 2016-02-22
Pregabalin Accord : EPAR - All Authorised presentations EN = English 2015-09-18 2016-02-22
Pregabalin Accord : EPAR - All Authorised presentations EN = English 2015-09-18 2016-02-22
Pregabalin Accord : EPAR - All Authorised presentations EN = English 2015-09-18 2016-02-22
Pregabalin Accord : EPAR - All Authorised presentations EN = English 2015-09-18 2016-02-22

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Pregabalin Accord : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2016-02-22 2018-03-07

Initial marketing-authorisation documents

Name Language First published Last updated
Pregabalin Accord : EPAR - Public assessment report EN = English 2015-09-18  
CHMP summary of positive opinion for Pregabalin Accord EN = English 2015-06-26  

Authorised

This medicine is approved for use in the European Union

More information on Pregabalin Accord