Pregabalin Mylan

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

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

What is Pregabalin Mylan and what is it used for?

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

  • epilepsy, where it 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).

Pregabalin Mylan is a ‘generic medicine’. This means that Pregabalin Mylan is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Lyrica. 

Pregabalin Mylan contains the active substance pregabalin.

How is Pregabalin Mylan used?

Pregabalin Mylan 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 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 Pregabalin Mylan should also be done gradually, over at least a week. Doctors may need to lower the dose in patients who have kidney problems.

How does Pregabalin Mylan work?

The active substance in Pregabalin Mylan, 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 epilepsy and anxiety.

How has Pregabalin Mylan been studied?

Because Pregabalin Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Lyrica. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Pregabalin Mylan?

Because Pregabalin Mylan 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 approved?

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

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

A risk management plan has been developed to ensure that Pregabalin Mylan is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pregabalin Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.

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

Other information about Pregabalin Mylan

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

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

Name Language First published Last updated
Pregabalin Mylan : EPAR - Summary for the public BG = bălgarski 31/07/2015  
Pregabalin Mylan : EPAR - Summary for the public ES = español 31/07/2015  
Pregabalin Mylan : EPAR - Summary for the public CS = čeština 31/07/2015  
Pregabalin Mylan : EPAR - Summary for the public DA = dansk 31/07/2015  
Pregabalin Mylan : EPAR - Summary for the public DE = Deutsch 31/07/2015  
Pregabalin Mylan : EPAR - Summary for the public ET = eesti keel 31/07/2015  
Pregabalin Mylan : EPAR - Summary for the public EL = elliniká 31/07/2015  
Pregabalin Mylan : EPAR - Summary for the public EN = English 31/07/2015  
Pregabalin Mylan : EPAR - Summary for the public FR = français 31/07/2015  
Pregabalin Mylan : EPAR - Summary for the public IT = italiano 31/07/2015  
Pregabalin Mylan : EPAR - Summary for the public LV = latviešu valoda 31/07/2015  
Pregabalin Mylan : EPAR - Summary for the public LT = lietuvių kalba 31/07/2015  
Pregabalin Mylan : EPAR - Summary for the public HU = magyar 31/07/2015  
Pregabalin Mylan : EPAR - Summary for the public MT = Malti 31/07/2015  
Pregabalin Mylan : EPAR - Summary for the public NL = Nederlands 31/07/2015  
Pregabalin Mylan : EPAR - Summary for the public PL = polski 31/07/2015  
Pregabalin Mylan : EPAR - Summary for the public PT = português 31/07/2015  
Pregabalin Mylan : EPAR - Summary for the public RO = română 31/07/2015  
Pregabalin Mylan : EPAR - Summary for the public SK = slovenčina 31/07/2015  
Pregabalin Mylan : EPAR - Summary for the public SL = slovenščina 31/07/2015  
Pregabalin Mylan : EPAR - Summary for the public FI = suomi 31/07/2015  
Pregabalin Mylan : EPAR - Summary for the public SV = svenska 31/07/2015  
Pregabalin Mylan : EPAR - Summary for the public HR = Hrvatski 31/07/2015  
Name Language First published Last updated
Pregabalin Mylan : EPAR - Risk-management-plan summary (English only) 31/07/2015 03/09/2015

This EPAR was last updated on 04/02/2016 .

Authorisation details

Product details

Product details for Pregabalin Mylan
NamePregabalin Mylan
Agency product numberEMEA/H/C/004078
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 Mylan
Marketing-authorisation holder

Generics (UK) Limited

Revision1
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

14/01/2016  Pregabalin Mylan -EMEA/H/C/004078 -WS/0859

Name Language First published Last updated
Pregabalin Mylan : EPAR - Product Information EN = English 31/07/2015 04/02/2016
Pregabalin Mylan : EPAR - Product Information EN = English 31/07/2015 04/02/2016
Pregabalin Mylan : EPAR - Product Information EN = English 31/07/2015 04/02/2016
Pregabalin Mylan : EPAR - Product Information EN = English 31/07/2015 04/02/2016
Pregabalin Mylan : EPAR - Product Information EN = English 31/07/2015 04/02/2016
Pregabalin Mylan : EPAR - Product Information EN = English 31/07/2015 04/02/2016
Pregabalin Mylan : EPAR - Product Information EN = English 31/07/2015 04/02/2016
Pregabalin Mylan : EPAR - Product Information EN = English 31/07/2015 04/02/2016
Pregabalin Mylan : EPAR - Product Information EN = English 31/07/2015 04/02/2016
Pregabalin Mylan : EPAR - Product Information EN = English 31/07/2015 04/02/2016
Pregabalin Mylan : EPAR - Product Information EN = English 31/07/2015 04/02/2016
Pregabalin Mylan : EPAR - Product Information EN = English 31/07/2015 04/02/2016
Pregabalin Mylan : EPAR - Product Information EN = English 31/07/2015 04/02/2016
Pregabalin Mylan : EPAR - Product Information EN = English 31/07/2015 04/02/2016
Pregabalin Mylan : EPAR - Product Information EN = English 31/07/2015 04/02/2016
Pregabalin Mylan : EPAR - Product Information EN = English 31/07/2015 04/02/2016
Pregabalin Mylan : EPAR - Product Information EN = English 31/07/2015 04/02/2016
Pregabalin Mylan : EPAR - Product Information EN = English 31/07/2015 04/02/2016
Pregabalin Mylan : EPAR - Product Information EN = English 31/07/2015 04/02/2016
Pregabalin Mylan : EPAR - Product Information EN = English 31/07/2015 04/02/2016
Pregabalin Mylan : EPAR - Product Information EN = English 31/07/2015 04/02/2016
Pregabalin Mylan : EPAR - Product Information EN = English 31/07/2015 04/02/2016
Pregabalin Mylan : EPAR - Product Information EN = English 31/07/2015 04/02/2016
Pregabalin Mylan : EPAR - Product Information EN = English 31/07/2015 04/02/2016
Pregabalin Mylan : EPAR - Product Information EN = English 31/07/2015 04/02/2016

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

Pharmacotherapeutic group

Antiepileptics

Therapeutic indication

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

Generalised Anxiety Disorder
Pregabalin Mylan 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 : EPAR - Procedural steps taken and scientific information after authorisation EN = English 04/02/2016  

Initial marketing-authorisation documents

Name Language First published Last updated
Pregabalin Mylan : EPAR - Public assessment report EN = English 31/07/2015  
CHMP summary of positive opinion for Pregabalin Mylan EN = English 24/04/2015 29/05/2015

Authorised

This medicine is approved for use in the European Union

More information on Pregabalin Mylan