Pregabalin Mylan Pharma

Withdrawn

This medicine's authorisation has been withdrawn

pregabalin

Overview

On 3 November 2021 the European Commission withdrew the marketing authorisation for Pregabalin Mylan Pharma (pregabalin) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Mylan S.A.S, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Pregabalin Mylan Pharma was granted marketing authorisation in the EU on 25 June 2015 for the treatment of neuropathic pain, epilepsy and generalised anxiety disorder (GAD). The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2019. 

Pregabalin Mylan Pharma is a generic medicine of Lyrica. There are other generic medicinal products of Lyrica authorised and marketed in the EU. 

The European Public Assessment Report (EPAR) for Pregabalin Mylan Pharma is updated to indicate that the marketing authorisation is no longer valid.

Pregabalin Mylan Pharma : EPAR - Summary for the public

Pregabalin Mylan Pharma : EPAR - Risk-management-plan summary

Product information

Pregabalin Mylan Pharma : EPAR - Product Information

Pregabalin Mylan Pharma : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Pregabalin Mylan Pharma
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/003962
• 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:
  Mylan S.A.S.

  117 Allee des Parcs; 69800 Saint-Priest; France

• Opinion adopted:
  23/04/2015
• Marketing authorisation issued:
  25/06/2015
• Revision:
  7

Assessment history

Changes since initial authorisation of medicine

Pregabalin Mylan Pharma : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Pregabalin Mylan Pharma : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/90102/2015

CHMP summary of positive opinion for Pregabalin Mylan Pharma

AdoptedReference Number: EMA/CHMP/236014/2015