Pregabalin Mylan Pharma

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This is a summary of the European public assessment report (EPAR) for Pregabalin Mylan Pharma. 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 Mylan Pharma.

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

What is Pregabalin Mylan Pharma and what is it used for?

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

  • 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 Mylan Pharma contains the active substance pregabalin.

Pregabalin Mylan Pharma is a ‘generic medicine’. This means that Pregabalin Mylan Pharma 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 Mylan Pharma used?

Pregabalin Mylan Pharma 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 Mylan Pharma 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 Mylan Pharma work?

The active substance in Pregabalin Mylan Pharma, 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 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.

How has Pregabalin Mylan Pharma 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 Mylan Pharma.

As for every medicine, the company provided studies on the quality of Pregabalin Mylan Pharma. 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 Mylan Pharma?

Because Pregabalin Mylan Pharma 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 Mylan Pharma approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pregabalin Mylan Pharma 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 Mylan Pharma be approved for use in the EU.

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

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

Other information about Pregabalin Mylan Pharma

The European Commission granted a marketing authorisation valid throughout the European Union for Pregabalin Mylan Pharma on 25 June 2015.

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

Name Language First published Last updated
Pregabalin Mylan Pharma : EPAR - Summary for the public BG = bălgarski 2015-07-31 2018-02-12
Pregabalin Mylan Pharma : EPAR - Summary for the public ES = español 2015-07-31 2018-02-12
Pregabalin Mylan Pharma : EPAR - Summary for the public CS = čeština 2015-07-31 2018-02-12
Pregabalin Mylan Pharma : EPAR - Summary for the public DA = dansk 2015-07-31 2018-02-12
Pregabalin Mylan Pharma : EPAR - Summary for the public DE = Deutsch 2015-07-31 2018-02-12
Pregabalin Mylan Pharma : EPAR - Summary for the public ET = eesti keel 2015-07-31 2018-02-12
Pregabalin Mylan Pharma : EPAR - Summary for the public EL = elliniká 2015-07-31 2018-02-12
Pregabalin Mylan Pharma : EPAR - Summary for the public EN = English 2015-07-31 2018-02-12
Pregabalin Mylan Pharma : EPAR - Summary for the public FR = français 2015-07-31 2018-02-12
Pregabalin Mylan Pharma : EPAR - Summary for the public IT = italiano 2015-07-31 2018-02-12
Pregabalin Mylan Pharma : EPAR - Summary for the public LV = latviešu valoda 2015-07-31 2018-02-12
Pregabalin Mylan Pharma : EPAR - Summary for the public LT = lietuvių kalba 2015-07-31 2018-02-12
Pregabalin Mylan Pharma : EPAR - Summary for the public HU = magyar 2015-07-31 2018-02-12
Pregabalin Mylan Pharma : EPAR - Summary for the public MT = Malti 2015-07-31 2018-02-12
Pregabalin Mylan Pharma : EPAR - Summary for the public NL = Nederlands 2015-07-31 2018-02-12
Pregabalin Mylan Pharma : EPAR - Summary for the public PL = polski 2015-07-31 2018-02-12
Pregabalin Mylan Pharma : EPAR - Summary for the public PT = português 2015-07-31 2018-02-12
Pregabalin Mylan Pharma : EPAR - Summary for the public RO = română 2015-07-31 2018-02-12
Pregabalin Mylan Pharma : EPAR - Summary for the public SK = slovenčina 2015-07-31 2018-02-12
Pregabalin Mylan Pharma : EPAR - Summary for the public SL = slovenščina 2015-07-31 2018-02-12
Pregabalin Mylan Pharma : EPAR - Summary for the public FI = suomi 2015-07-31 2018-02-12
Pregabalin Mylan Pharma : EPAR - Summary for the public SV = svenska 2015-07-31 2018-02-12
Pregabalin Mylan Pharma : EPAR - Summary for the public HR = Hrvatski 2015-07-31 2018-02-12
Name Language First published Last updated
Pregabalin Mylan Pharma : EPAR - Risk-management-plan summary (English only) 2015-07-31  

This EPAR was last updated on 14/05/2018 .

Authorisation details

Product details

Product details for Pregabalin Mylan Pharma
NamePregabalin Mylan Pharma
Agency product numberEMEA/H/C/003962
Active substance

pregabalin

International non-proprietary name (INN) or common name

pregabalin

Therapeutic area EpilepsyAnxiety DisordersNeuralgia
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 Mylan Pharma
Marketing-authorisation holder

Generics UK Limited

Revision3
Date of issue of marketing authorisation valid throughout the European Union25/06/2015

Contact address:

Generics UK Limited
Station Close 
Potters Bar 
Hertfordshire 
EN6 1TL 
United Kingdom

Product information

Product information

09/03/2018  Pregabalin Mylan Pharma -EMEA/H/C/003962 -IB/0007

Name Language First published Last updated
Pregabalin Mylan Pharma : EPAR - Product Information EN = English 2015-07-31 2018-05-14
Pregabalin Mylan Pharma : EPAR - Product Information EN = English 2015-07-31 2018-05-14
Pregabalin Mylan Pharma : EPAR - Product Information EN = English 2015-07-31 2018-05-14
Pregabalin Mylan Pharma : EPAR - Product Information EN = English 2015-07-31 2018-05-14
Pregabalin Mylan Pharma : EPAR - Product Information EN = English 2015-07-31 2018-05-14
Pregabalin Mylan Pharma : EPAR - Product Information EN = English 2015-07-31 2018-05-14
Pregabalin Mylan Pharma : EPAR - Product Information EN = English 2015-07-31 2018-05-14
Pregabalin Mylan Pharma : EPAR - Product Information EN = English 2015-07-31 2018-05-14
Pregabalin Mylan Pharma : EPAR - Product Information EN = English 2015-07-31 2018-05-14
Pregabalin Mylan Pharma : EPAR - Product Information EN = English 2015-07-31 2018-05-14
Pregabalin Mylan Pharma : EPAR - Product Information EN = English 2015-07-31 2018-05-14
Pregabalin Mylan Pharma : EPAR - Product Information EN = English 2015-07-31 2018-05-14
Pregabalin Mylan Pharma : EPAR - Product Information EN = English 2015-07-31 2018-05-14
Pregabalin Mylan Pharma : EPAR - Product Information EN = English 2015-07-31 2018-05-14
Pregabalin Mylan Pharma : EPAR - Product Information EN = English 2015-07-31 2018-05-14
Pregabalin Mylan Pharma : EPAR - Product Information EN = English 2015-07-31 2018-05-14
Pregabalin Mylan Pharma : EPAR - Product Information EN = English 2015-07-31 2018-05-14
Pregabalin Mylan Pharma : EPAR - Product Information EN = English 2015-07-31 2018-05-14
Pregabalin Mylan Pharma : EPAR - Product Information EN = English 2015-07-31 2018-05-14
Pregabalin Mylan Pharma : EPAR - Product Information EN = English 2015-07-31 2018-05-14
Pregabalin Mylan Pharma : EPAR - Product Information EN = English 2015-07-31 2018-05-14
Pregabalin Mylan Pharma : EPAR - Product Information EN = English 2015-07-31 2018-05-14
Pregabalin Mylan Pharma : EPAR - Product Information EN = English 2015-07-31 2018-05-14
Pregabalin Mylan Pharma : EPAR - Product Information EN = English 2015-07-31 2018-05-14
Pregabalin Mylan Pharma : EPAR - Product Information EN = English 2015-07-31 2018-05-14

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 Mylan Pharma : EPAR - All Authorised presentations EN = English 2015-07-31  
Pregabalin Mylan Pharma : EPAR - All Authorised presentations EN = English 2015-07-31  
Pregabalin Mylan Pharma : EPAR - All Authorised presentations EN = English 2015-07-31  
Pregabalin Mylan Pharma : EPAR - All Authorised presentations EN = English 2015-07-31  
Pregabalin Mylan Pharma : EPAR - All Authorised presentations EN = English 2015-07-31  
Pregabalin Mylan Pharma : EPAR - All Authorised presentations EN = English 2015-07-31  
Pregabalin Mylan Pharma : EPAR - All Authorised presentations EN = English 2015-07-31  
Pregabalin Mylan Pharma : EPAR - All Authorised presentations EN = English 2015-07-31  
Pregabalin Mylan Pharma : EPAR - All Authorised presentations EN = English 2015-07-31  
Pregabalin Mylan Pharma : EPAR - All Authorised presentations EN = English 2015-07-31  
Pregabalin Mylan Pharma : EPAR - All Authorised presentations EN = English 2015-07-31  
Pregabalin Mylan Pharma : EPAR - All Authorised presentations EN = English 2015-07-31  
Pregabalin Mylan Pharma : EPAR - All Authorised presentations EN = English 2015-07-31  
Pregabalin Mylan Pharma : EPAR - All Authorised presentations EN = English 2015-07-31  
Pregabalin Mylan Pharma : EPAR - All Authorised presentations EN = English 2015-07-31  
Pregabalin Mylan Pharma : EPAR - All Authorised presentations EN = English 2015-07-31  
Pregabalin Mylan Pharma : EPAR - All Authorised presentations EN = English 2015-07-31  
Pregabalin Mylan Pharma : EPAR - All Authorised presentations EN = English 2015-07-31  
Pregabalin Mylan Pharma : EPAR - All Authorised presentations EN = English 2015-07-31  
Pregabalin Mylan Pharma : EPAR - All Authorised presentations EN = English 2015-07-31  
Pregabalin Mylan Pharma : EPAR - All Authorised presentations EN = English 2015-07-31  
Pregabalin Mylan Pharma : EPAR - All Authorised presentations EN = English 2015-07-31  
Pregabalin Mylan Pharma : EPAR - All Authorised presentations EN = English 2015-07-31  
Pregabalin Mylan Pharma : EPAR - All Authorised presentations EN = English 2015-07-31  
Pregabalin Mylan Pharma : EPAR - All Authorised presentations EN = English 2015-07-31  

Pharmacotherapeutic group

Antiepileptics

Therapeutic indication

Epilepsy

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

Generalised Anxiety Disorder

Pregabalin Mylan Pharma 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 Mylan Pharma : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2016-02-19 2018-05-14

Initial marketing-authorisation documents

Name Language First published Last updated
Pregabalin Mylan Pharma : EPAR - Public assessment report EN = English 2015-07-31  
CHMP summary of positive opinion for Pregabalin Mylan Pharma EN = English 2015-04-24  

Authorised

This medicine is approved for use in the European Union

More information on Pregabalin Mylan Pharma