Pregabalin Sandoz

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

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

What is Pregabalin Sandoz and what is it used for?

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

Pregabalin Sandoz contains the active substance pregabalin.

How is Pregabalin Sandoz used?

Pregabalin Sandoz 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 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 work?

The active substance in Pregabalin Sandoz, 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 Sandoz been studied?

Because Pregabalin Sandoz 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?

Because Pregabalin Sandoz 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 approved?

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

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

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

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

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

Name Language First published Last updated
Pregabalin Sandoz : EPAR - Summary for the public BG = bălgarski 2015-07-16  
Pregabalin Sandoz : EPAR - Summary for the public ES = español 2015-07-16  
Pregabalin Sandoz : EPAR - Summary for the public CS = čeština 2015-07-16  
Pregabalin Sandoz : EPAR - Summary for the public DA = dansk 2015-07-16  
Pregabalin Sandoz : EPAR - Summary for the public DE = Deutsch 2015-07-16  
Pregabalin Sandoz : EPAR - Summary for the public ET = eesti keel 2015-07-16  
Pregabalin Sandoz : EPAR - Summary for the public EL = elliniká 2015-07-16  
Pregabalin Sandoz : EPAR - Summary for the public EN = English 2015-07-16  
Pregabalin Sandoz : EPAR - Summary for the public FR = français 2015-07-16  
Pregabalin Sandoz : EPAR - Summary for the public IT = italiano 2015-07-16  
Pregabalin Sandoz : EPAR - Summary for the public LV = latviešu valoda 2015-07-16  
Pregabalin Sandoz : EPAR - Summary for the public LT = lietuvių kalba 2015-07-16  
Pregabalin Sandoz : EPAR - Summary for the public HU = magyar 2015-07-16  
Pregabalin Sandoz : EPAR - Summary for the public MT = Malti 2015-07-16  
Pregabalin Sandoz : EPAR - Summary for the public NL = Nederlands 2015-07-16  
Pregabalin Sandoz : EPAR - Summary for the public PL = polski 2015-07-16  
Pregabalin Sandoz : EPAR - Summary for the public PT = português 2015-07-16  
Pregabalin Sandoz : EPAR - Summary for the public RO = română 2015-07-16  
Pregabalin Sandoz : EPAR - Summary for the public SK = slovenčina 2015-07-16  
Pregabalin Sandoz : EPAR - Summary for the public SL = slovenščina 2015-07-16  
Pregabalin Sandoz : EPAR - Summary for the public FI = suomi 2015-07-16  
Pregabalin Sandoz : EPAR - Summary for the public SV = svenska 2015-07-16  
Pregabalin Sandoz : EPAR - Summary for the public HR = Hrvatski 2015-07-16  
Name Language First published Last updated
Pregabalin Sandoz : EPAR - Risk-management-plan summary (English only) 2015-07-16  

This EPAR was last updated on 04/04/2018 .

Authorisation details

Product details

Product details for Pregabalin Sandoz
NamePregabalin Sandoz
Agency product numberEMEA/H/C/004010
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 Sandoz
Marketing-authorisation holder

Sandoz GmbH

Revision3
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

05/02/2018  Pregabalin Sandoz -EMEA/H/C/004010 -IB/0005

Name Language First published Last updated
Pregabalin Sandoz : EPAR - Product Information EN = English 2015-07-16 2018-04-04
Pregabalin Sandoz : EPAR - Product Information EN = English 2015-07-16 2018-04-04
Pregabalin Sandoz : EPAR - Product Information EN = English 2015-07-16 2018-04-04
Pregabalin Sandoz : EPAR - Product Information EN = English 2015-07-16 2018-04-04
Pregabalin Sandoz : EPAR - Product Information EN = English 2015-07-16 2018-04-04
Pregabalin Sandoz : EPAR - Product Information EN = English 2015-07-16 2018-04-04
Pregabalin Sandoz : EPAR - Product Information EN = English 2015-07-16 2018-04-04
Pregabalin Sandoz : EPAR - Product Information EN = English 2015-07-16 2018-04-04
Pregabalin Sandoz : EPAR - Product Information EN = English 2015-07-16 2018-04-04
Pregabalin Sandoz : EPAR - Product Information EN = English 2015-07-16 2018-04-04
Pregabalin Sandoz : EPAR - Product Information EN = English 2015-07-16 2018-04-04
Pregabalin Sandoz : EPAR - Product Information EN = English 2015-07-16 2018-04-04
Pregabalin Sandoz : EPAR - Product Information EN = English 2015-07-16 2018-04-04
Pregabalin Sandoz : EPAR - Product Information EN = English 2015-07-16 2018-04-04
Pregabalin Sandoz : EPAR - Product Information EN = English 2015-07-16 2018-04-04
Pregabalin Sandoz : EPAR - Product Information EN = English 2015-07-16 2018-04-04
Pregabalin Sandoz : EPAR - Product Information EN = English 2015-07-16 2018-04-04
Pregabalin Sandoz : EPAR - Product Information EN = English 2015-07-16 2018-04-04
Pregabalin Sandoz : EPAR - Product Information EN = English 2015-07-16 2018-04-04
Pregabalin Sandoz : EPAR - Product Information EN = English 2015-07-16 2018-04-04
Pregabalin Sandoz : EPAR - Product Information EN = English 2015-07-16 2018-04-04
Pregabalin Sandoz : EPAR - Product Information EN = English 2015-07-16 2018-04-04
Pregabalin Sandoz : EPAR - Product Information EN = English 2015-07-16 2018-04-04
Pregabalin Sandoz : EPAR - Product Information EN = English 2015-07-16 2018-04-04
Pregabalin Sandoz : EPAR - Product Information EN = English 2015-07-16 2018-04-04

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 : EPAR - All Authorised presentations EN = English 2015-07-16 2015-11-26
Pregabalin Sandoz : EPAR - All Authorised presentations EN = English 2015-07-16 2015-11-26
Pregabalin Sandoz : EPAR - All Authorised presentations EN = English 2015-07-16 2015-11-26
Pregabalin Sandoz : EPAR - All Authorised presentations EN = English 2015-07-16 2015-11-26
Pregabalin Sandoz : EPAR - All Authorised presentations EN = English 2015-07-16 2015-11-26
Pregabalin Sandoz : EPAR - All Authorised presentations EN = English 2015-07-16 2015-11-26
Pregabalin Sandoz : EPAR - All Authorised presentations EN = English 2015-07-16 2015-11-26
Pregabalin Sandoz : EPAR - All Authorised presentations EN = English 2015-07-16 2015-11-26
Pregabalin Sandoz : EPAR - All Authorised presentations EN = English 2015-07-16 2015-11-26
Pregabalin Sandoz : EPAR - All Authorised presentations EN = English 2015-07-16 2015-11-26
Pregabalin Sandoz : EPAR - All Authorised presentations EN = English 2015-07-16 2015-11-26
Pregabalin Sandoz : EPAR - All Authorised presentations EN = English 2015-07-16 2015-11-26
Pregabalin Sandoz : EPAR - All Authorised presentations EN = English 2015-07-16 2015-11-26
Pregabalin Sandoz : EPAR - All Authorised presentations EN = English 2015-07-16 2015-11-26
Pregabalin Sandoz : EPAR - All Authorised presentations EN = English 2015-07-16 2015-11-26
Pregabalin Sandoz : EPAR - All Authorised presentations EN = English 2015-07-16 2015-11-26
Pregabalin Sandoz : EPAR - All Authorised presentations EN = English 2015-07-16 2015-11-26
Pregabalin Sandoz : EPAR - All Authorised presentations EN = English 2015-07-16 2015-11-26
Pregabalin Sandoz : EPAR - All Authorised presentations EN = English 2015-07-16 2015-11-26
Pregabalin Sandoz : EPAR - All Authorised presentations EN = English 2015-07-16 2015-11-26
Pregabalin Sandoz : EPAR - All Authorised presentations EN = English 2015-07-16 2015-11-26
Pregabalin Sandoz : EPAR - All Authorised presentations EN = English 2015-07-16 2015-11-26
Pregabalin Sandoz : EPAR - All Authorised presentations EN = English 2015-07-16 2015-11-26
Pregabalin Sandoz : EPAR - All Authorised presentations EN = English 2015-07-16 2015-11-26
Pregabalin Sandoz : EPAR - All Authorised presentations EN = English 2015-07-16 2015-11-26

Pharmacotherapeutic group

Antiepileptics

Therapeutic indication

Neuropathic pain

Pregabalin Sandoz is indicated for the treatment of peripheral and central neuropathic pain in adults.

Epilepsy

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

Generalised Anxiety Disorder

Pregabalin Sandoz 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 : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2015-11-26 2018-04-04

Initial marketing-authorisation documents

Name Language First published Last updated
Pregabalin Sandoz : EPAR - Public assessment report EN = English 2015-07-16  
CHMP summary of positive opinion for Pregabalin Sandoz EN = English 2015-04-24  

Authorised

This medicine is approved for use in the European Union

More information on Pregabalin Sandoz