Pregabalin Sandoz GmbH

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

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

What is Pregabalin Sandoz GmbH and what is it used for?

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

Pregabalin Sandoz GmbH contains the active substance pregabalin.

How is Pregabalin Sandoz GmbH used?

Pregabalin Sandoz GmbH 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 Sandoz GmbH 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 Sandoz GmbH work?

The active substance in Pregabalin Sandoz GmbH, 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 Sandoz GmbH been studied?

Because Pregabalin Sandoz GmbH 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 Sandoz GmbH?

Because Pregabalin Sandoz GmbH 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 Sandoz GmbH approved?

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

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

A risk management plan has been developed to ensure that Pregabalin Sandoz GmbH 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 Sandoz GmbH, 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 Sandoz GmbH

The European Commission granted a marketing authorisation valid throughout the European Union for Pregabalin Sandoz GmbH on 19 June 2015.

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

Name Language First published Last updated
Pregabalin Sandoz GmbH : EPAR - Summary for the public BG = bălgarski 2015-07-21  
Pregabalin Sandoz GmbH : EPAR - Summary for the public ES = español 2015-07-21  
Pregabalin Sandoz GmbH : EPAR - Summary for the public CS = čeština 2015-07-21  
Pregabalin Sandoz GmbH : EPAR - Summary for the public DA = dansk 2015-07-21  
Pregabalin Sandoz GmbH : EPAR - Summary for the public DE = Deutsch 2015-07-21  
Pregabalin Sandoz GmbH : EPAR - Summary for the public ET = eesti keel 2015-07-21  
Pregabalin Sandoz GmbH : EPAR - Summary for the public EL = elliniká 2015-07-21  
Pregabalin Sandoz GmbH : EPAR - Summary for the public EN = English 2015-07-21  
Pregabalin Sandoz GmbH : EPAR - Summary for the public FR = français 2015-07-21  
Pregabalin Sandoz GmbH : EPAR - Summary for the public IT = italiano 2015-07-21  
Pregabalin Sandoz GmbH : EPAR - Summary for the public LV = latviešu valoda 2015-07-21  
Pregabalin Sandoz GmbH : EPAR - Summary for the public LT = lietuvių kalba 2015-07-21  
Pregabalin Sandoz GmbH : EPAR - Summary for the public HU = magyar 2015-07-21  
Pregabalin Sandoz GmbH : EPAR - Summary for the public MT = Malti 2015-07-21  
Pregabalin Sandoz GmbH : EPAR - Summary for the public NL = Nederlands 2015-07-21  
Pregabalin Sandoz GmbH : EPAR - Summary for the public PL = polski 2015-07-21  
Pregabalin Sandoz GmbH : EPAR - Summary for the public PT = português 2015-07-21  
Pregabalin Sandoz GmbH : EPAR - Summary for the public RO = română 2015-07-21  
Pregabalin Sandoz GmbH : EPAR - Summary for the public SK = slovenčina 2015-07-21  
Pregabalin Sandoz GmbH : EPAR - Summary for the public SL = slovenščina 2015-07-21  
Pregabalin Sandoz GmbH : EPAR - Summary for the public FI = suomi 2015-07-21  
Pregabalin Sandoz GmbH : EPAR - Summary for the public SV = svenska 2015-07-21  
Pregabalin Sandoz GmbH : EPAR - Summary for the public HR = Hrvatski 2015-07-21  
Name Language First published Last updated
Pregabalin Sandoz GmbH : EPAR - Risk-management-plan summary (English only) 2015-07-21  

This EPAR was last updated on 29/01/2016 .

Authorisation details

Product details

Product details for Pregabalin Sandoz GmbH
NamePregabalin Sandoz GmbH
Agency product numberEMEA/H/C/004070
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 Sandoz GmbH
Marketing-authorisation holder

Sandoz GmbH

Revision2
Date of issue of marketing authorisation valid throughout the European Union19/06/2015

Contact address:

Sandoz GmbH
Biochemiestr. 10 
6250 Kundl 
Austria

Product information

Product information

14/10/2015  Pregabalin Sandoz GmbH -EMEA/H/C/004070 -IB/0003

Name Language First published Last updated
Pregabalin Sandoz GmbH : EPAR - Product Information EN = English 2015-07-21 2016-01-29
Pregabalin Sandoz GmbH : EPAR - Product Information EN = English 2015-07-21 2016-01-29
Pregabalin Sandoz GmbH : EPAR - Product Information EN = English 2015-07-21 2016-01-29
Pregabalin Sandoz GmbH : EPAR - Product Information EN = English 2015-07-21 2016-01-29
Pregabalin Sandoz GmbH : EPAR - Product Information EN = English 2015-07-21 2016-01-29
Pregabalin Sandoz GmbH : EPAR - Product Information EN = English 2015-07-21 2016-01-29
Pregabalin Sandoz GmbH : EPAR - Product Information EN = English 2015-07-21 2016-01-29
Pregabalin Sandoz GmbH : EPAR - Product Information EN = English 2015-07-21 2016-01-29
Pregabalin Sandoz GmbH : EPAR - Product Information EN = English 2015-07-21 2016-01-29
Pregabalin Sandoz GmbH : EPAR - Product Information EN = English 2015-07-21 2016-01-29
Pregabalin Sandoz GmbH : EPAR - Product Information EN = English 2015-07-21 2016-01-29
Pregabalin Sandoz GmbH : EPAR - Product Information EN = English 2015-07-21 2016-01-29
Pregabalin Sandoz GmbH : EPAR - Product Information EN = English 2015-07-21 2016-01-29
Pregabalin Sandoz GmbH : EPAR - Product Information EN = English 2015-07-21 2016-01-29
Pregabalin Sandoz GmbH : EPAR - Product Information EN = English 2015-07-21 2016-01-29
Pregabalin Sandoz GmbH : EPAR - Product Information EN = English 2015-07-21 2016-01-29
Pregabalin Sandoz GmbH : EPAR - Product Information EN = English 2015-07-21 2016-01-29
Pregabalin Sandoz GmbH : EPAR - Product Information EN = English 2015-07-21 2016-01-29
Pregabalin Sandoz GmbH : EPAR - Product Information EN = English 2015-07-21 2016-01-29
Pregabalin Sandoz GmbH : EPAR - Product Information EN = English 2015-07-21 2016-01-29
Pregabalin Sandoz GmbH : EPAR - Product Information EN = English 2015-07-21 2016-01-29
Pregabalin Sandoz GmbH : EPAR - Product Information EN = English 2015-07-21 2016-01-29
Pregabalin Sandoz GmbH : EPAR - Product Information EN = English 2015-07-21 2016-01-29
Pregabalin Sandoz GmbH : EPAR - Product Information EN = English 2015-07-21 2016-01-29
Pregabalin Sandoz GmbH : EPAR - Product Information EN = English 2015-07-21 2016-01-29

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 Sandoz GmbH : EPAR - All Authorised presentations EN = English 2015-07-21 2015-12-21
Pregabalin Sandoz GmbH : EPAR - All Authorised presentations EN = English 2015-07-21 2015-12-21
Pregabalin Sandoz GmbH : EPAR - All Authorised presentations EN = English 2015-07-21 2015-12-21
Pregabalin Sandoz GmbH : EPAR - All Authorised presentations EN = English 2015-07-21 2015-12-21
Pregabalin Sandoz GmbH : EPAR - All Authorised presentations EN = English 2015-07-21 2015-12-21
Pregabalin Sandoz GmbH : EPAR - All Authorised presentations EN = English 2015-07-21 2015-12-21
Pregabalin Sandoz GmbH : EPAR - All Authorised presentations EN = English 2015-07-21 2015-12-21
Pregabalin Sandoz GmbH : EPAR - All Authorised presentations EN = English 2015-07-21 2015-12-21
Pregabalin Sandoz GmbH : EPAR - All Authorised presentations EN = English 2015-07-21 2015-12-21
Pregabalin Sandoz GmbH : EPAR - All Authorised presentations EN = English 2015-07-21 2015-12-21
Pregabalin Sandoz GmbH : EPAR - All Authorised presentations EN = English 2015-07-21 2015-12-21
Pregabalin Sandoz GmbH : EPAR - All Authorised presentations EN = English 2015-07-21 2015-12-21
Pregabalin Sandoz GmbH : EPAR - All Authorised presentations EN = English 2015-07-21 2015-12-21
Pregabalin Sandoz GmbH : EPAR - All Authorised presentations EN = English 2015-07-21 2015-12-21
Pregabalin Sandoz GmbH : EPAR - All Authorised presentations EN = English 2015-07-21 2015-12-21
Pregabalin Sandoz GmbH : EPAR - All Authorised presentations EN = English 2015-07-21 2015-12-21
Pregabalin Sandoz GmbH : EPAR - All Authorised presentations EN = English 2015-07-21 2015-12-21
Pregabalin Sandoz GmbH : EPAR - All Authorised presentations EN = English 2015-07-21 2015-12-21
Pregabalin Sandoz GmbH : EPAR - All Authorised presentations EN = English 2015-07-21 2015-12-21
Pregabalin Sandoz GmbH : EPAR - All Authorised presentations EN = English 2015-07-21 2015-12-21
Pregabalin Sandoz GmbH : EPAR - All Authorised presentations EN = English 2015-07-21 2015-12-21
Pregabalin Sandoz GmbH : EPAR - All Authorised presentations EN = English 2015-07-21 2015-12-21
Pregabalin Sandoz GmbH : EPAR - All Authorised presentations EN = English 2015-07-21 2015-12-21
Pregabalin Sandoz GmbH : EPAR - All Authorised presentations EN = English 2015-07-21 2015-12-21
Pregabalin Sandoz GmbH : EPAR - All Authorised presentations EN = English 2015-07-21 2015-12-21

Pharmacotherapeutic group

Antiepileptics

Therapeutic indication

Epilepsy

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

Generalised Anxiety Disorder

Pregabalin Sandoz GmbH 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 Sandoz GmbH : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2015-12-21 2016-01-29

Initial marketing-authorisation documents

Name Language First published Last updated
Pregabalin Sandoz GmbH : EPAR - Public assessment report EN = English 2015-07-21  
CHMP summary of positive opinion for Pregabalin Sandoz GmbH EN = English 2015-04-24 2015-05-29

Authorised

This medicine is approved for use in the European Union

More information on Pregabalin Sandoz GmbH