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 14/05/2018

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
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 medicines.

Publication details
Marketing-authorisation holder
Generics UK Limited
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
25/06/2015
Contact address
Station Close
Potters Bar
Hertfordshire
EN6 1TL
United Kingdom

Product information

09/03/2018 Pregabalin Mylan Pharma - EMEA/H/C/003962 - IB/0007

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.

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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