Pregabalin Sandoz GmbH

Withdrawn

This medicine's authorisation has been withdrawn

pregabalin

Overview

The marketing authorisation for Pregabalin Sandoz GmbH has been withdrawn at the request of the marketing-authorisation holder.

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

Latest procedure affecting product information: IA/0032

21/09/2023

This medicine’s product information is available in all official EU languages.
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Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

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
• 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