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The marketing authorisation for Pregabalin Sandoz GmbH has been withdrawn at the request of the marketing-authorisation holder.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
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
AntiepilepticsTherapeutic 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.
Assessment history
Pregabalin Sandoz GmbH : EPAR - Procedural steps taken and scientific information after authorisation