Pregabalin Mylan Pharma

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pregabalin

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Pregabalin Mylan Pharma has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 26/04/2022

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
7
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

14/01/2021 Pregabalin Mylan Pharma - EMEA/H/C/003962 - WS/2006

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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