Pregabalin Pfizer
pregabalin
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Pregabalin Pfizer. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Pregabalin Pfizer.
For practical information about using Pregabalin Pfizer, patients should read the package leaflet or contact their doctor or pharmacist.
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List item
Pregabalin Pfizer : EPAR - Summary for the public (PDF/81.54 KB)
First published: 07/05/2014
Last updated: 07/05/2014
EMA/220635/2014 -
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Pregabalin Pfizer : EPAR - Risk-management-plan summary (PDF/135.59 KB)
First published: 17/12/2018
Last updated: 21/04/2022
Authorisation details
Product details | |
---|---|
Name |
Pregabalin Pfizer
|
Agency product number |
EMEA/H/C/003880
|
Active substance |
pregabalin
|
International non-proprietary name (INN) or common name |
pregabalin
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
N03AX16
|
Publication details | |
---|---|
Marketing-authorisation holder |
Upjohn EESV
|
Revision |
29
|
Date of issue of marketing authorisation valid throughout the European Union |
10/04/2014
|
Contact address |
Rivium Westlaan 142 |
Product information
14/03/2023 Pregabalin Pfizer - EMEA/H/C/003880 - N/0050
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antiepileptics
Therapeutic indication
Neuropathic pain
- Pregabalin Pfizer is indicated for the treatment of peripheral and central neuropathic pain in adults.
Epilepsy
- Pregabalin Pfizer is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Generalised Anxiety Disorder
- Pregabalin Pfizer is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.