Pregabalin Zentiva k.s.

Withdrawn

This medicine's authorisation has been withdrawn

pregabalin

Overview

On 23 February 2023, the European Commission withdrew the marketing authorisation for Pregabalin Zentiva k.s. (pregabalin) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Zentiva k.s., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Pregabalin Zentiva k.s. was granted marketing authorisation in the EU on 27 February 2017 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 2021. 

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Public Assessment Report (EPAR) for Pregabalin Zentiva k.s. is updated to indicate that the marketing authorisation is no longer valid.

Pregabalin Zentiva k.s. : EPAR - Summary for the public

Reference Number: EMA/14344/2017

Pregabalin Zentiva k.s. : EPAR - Risk management plan summary

Product information

Pregabalin Zentiva k.s. : EPAR - Product Information

Pregabalin Zentiva k.s. : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Pregabalin Zentiva k.s.
• 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

Neuropathic pain

• Pregabalin Zentiva k.s. is indicated for the treatment of peripheral and central neuropathic pain in adults.

Epilepsy

• Pregabalin Zentiva k.s. is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

Generalised anxiety disorder

• Pregabalin Zentiva k.s. is indicated for the treatment of generalised anxiety disorder (GAD) in adults.

Authorisation details

• EMA product number:
  EMEA/H/C/004277
• 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:
  Zentiva k.s.

  U Kabelovny 130 ; Dolni Mecholupy 102 37 ; Prague 10 ; Czech Republic

• Opinion adopted:
  15/12/2016
• Marketing authorisation issued:
  27/02/2017
• Revision:
  13

Assessment history

Changes since initial authorisation of medicine

Pregabalin Zentiva k.s. : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Pregabalin Zentiva k.s. : EPAR - Public assessment report

AdoptedReference Number: EMA/14344/2017

CHMP summary of positive opinion for Pregabalin Zentiva k.s.

AdoptedReference Number: EMA/CHMP/643488/2016