Pregabalin Sandoz GmbH
pregabalin
Table of contents
Overview
The marketing authorisation for Pregabalin Sandoz GmbH has been withdrawn at the request of the marketing-authorisation holder.
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List item
Pregabalin Sandoz GmbH : EPAR - Summary for the public (PDF/203.49 KB)
First published: 21/07/2015
Last updated: 12/10/2023
EMA/277981/2015 -
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List item
Pregabalin Sandoz GmbH : EPAR - Risk-management-plan summary (PDF/110.02 KB)
First published: 21/07/2015
Last updated: 12/10/2023
Authorisation details
| Product details | |
|---|---|
| Name |
Pregabalin Sandoz GmbH
|
| Agency product number |
EMEA/H/C/004070
|
| Active substance |
pregabalin
|
| International non-proprietary name (INN) or common name |
pregabalin
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
N03AX16
|
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. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Sandoz GmbH
|
| Revision |
16
|
| Date of issue of marketing authorisation valid throughout the European Union |
19/06/2015
|
| Contact address |
Biochemiestr. 10
6250 Kundl Austria |
Product information
21/09/2023 Pregabalin Sandoz GmbH - EMEA/H/C/004070 - IA/0032
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
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.