Overview

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.

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.

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.

The active substance in Pregabalin Sandoz, pregabalin, is similar in structure to the body’s own ‘neurotransmitter’ gamma?amino 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.

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.

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.

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.

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 Pregabalin Sandoz : EPAR - Risk-management-plan summary.

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.

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Product information

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Latest procedure affecting product information: VR/0000168879

07/03/2024

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This medicine’s product information is available in all official EU languages.
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Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

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Product details

Name of medicine
Pregabalin Sandoz
Active substance
pregabalin
International non-proprietary name (INN) or common name
pregabalin
Therapeutic area (MeSH)
  • Anxiety Disorders
  • Neuralgia
  • Epilepsy
Anatomical therapeutic chemical (ATC) code
N03AX16

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.

Authorisation details

EMA product number
EMEA/H/C/004010

Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Marketing authorisation holder
Sandoz GmbH

Biochemiestr. 10
6250 Kundl
Austria

Opinion adopted
23/04/2015
Marketing authorisation issued
19/06/2015
Revision
18

Assessment history

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