Pregabalin Mylan Pharma

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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 Mylan Pharma. 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 Pharma.

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

This EPAR was last updated on 10/04/2019

Authorisation details

Product details
Name
Pregabalin Mylan Pharma
Agency product number
EMEA/H/C/003962
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
GenericGeneric

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
Mylan S.A.S.
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
25/06/2015
Contact address

117 Allee des Parcs
69800 Saint-Priest
France

Product information

18/03/2019 Pregabalin Mylan Pharma - EMEA/H/C/003962 - N/0010

Contents

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You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antiepileptics

Therapeutic indication

Epilepsy

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

Generalised Anxiety Disorder

Pregabalin Mylan Pharma is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.

Assessment history

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