Pregabalin Sandoz GmbH

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pregabalin

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 15/05/2018

Authorisation details

Product details
Name
Pregabalin Sandoz GmbH
Agency product number
EMEA/H/C/004070
Active substance
pregabalin
International non-proprietary name (INN) or common name
pregabalin
Therapeutic area (MeSH)
  • Anxiety Disorders
  • Epilepsy
Anatomical therapeutic chemical (ATC) code
N03AX16
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.

Publication details
Marketing-authorisation holder
Sandoz GmbH
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
19/06/2015
Contact address
Biochemiestr. 10
6250 Kundl
Austria

Product information

26/01/2018 Pregabalin Sandoz GmbH - EMEA/H/C/004070 - IB/0010/G

Contents

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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

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