Pregabalin Sandoz GmbH

Withdrawn

This medicine's authorisation has been withdrawn

pregabalin

Overview

On 4 October 2023, the European Commission withdrew the marketing authorisation for Pregabalin Sandoz GmbH (pregabalin) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Sandoz GmbH, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Pregabalin Sandoz GmbH was granted marketing authorisation in the EU on 19 June 2015 for the treatment of epilepsy and generalised anxiety disorder (GAD). The marketing authorisation was initially valid for a 5-year period. It was subsequently granted unlimited validity in 2020. 

Pregabalin Sandoz GmbH 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Public Assessment Report (EPAR) for Pregabalin Sandoz GmbH is updated to indicate that the marketing authorisation is no longer valid.

Pregabalin Sandoz GmbH : EPAR - Summary for the public

Reference Number: EMA/277981/2015

Pregabalin Sandoz GmbH : EPAR - Risk-management-plan summary

Product information

Pregabalin Sandoz GmbH : EPAR - Product Information

Pregabalin Sandoz GmbH : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Pregabalin Sandoz GmbH
• Active substance:
  pregabalin
• International non-proprietary name (INN) or common name:
  pregabalin
• Therapeutic area (MeSH):
  • Anxiety Disorders
  • Epilepsy
• Anatomical therapeutic chemical (ATC) code:
  N03AX16

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.

Authorisation details

• EMA product number:
  EMEA/H/C/004070
• 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:
  Sandoz GmbH

  Biochemiestr. 10; 6250 Kundl ; Austria

• Opinion adopted:
  23/04/2015
• Marketing authorisation issued:
  19/06/2015
• Withdrawal of marketing authorisation:
  04/10/2023
• Revision:
  16

Assessment history

Changes since initial authorisation of medicine

Pregabalin Sandoz GmbH : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Pregabalin Sandoz GmbH : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/102870/2015

CHMP summary of positive opinion for Pregabalin Sandoz GmbH

AdoptedReference Number: EMA/CHMP/244649/2015 Rev. 1