Pregabalin Zentiva k.s.
pregabalin
Table of contents
Overview
The marketing authorisation for Pregabalin Zentiva k.s. has been withdrawn at the request of the marketing-authorisation holder.
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Pregabalin Zentiva k.s. : EPAR - Summary for the public (PDF/708.49 KB) (updated)
First published: 06/03/2017
Last updated: 20/03/2023
EMA/14344/2017 -
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Pregabalin Zentiva k.s. : EPAR - Risk management plan summary (PDF/718.86 KB) (updated)
First published: 05/05/2022
Last updated: 20/03/2023
Authorisation details
| Product details | |
|---|---|
| Name |
Pregabalin Zentiva k.s.
|
| Agency product number |
EMEA/H/C/004277
|
| 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 |
Zentiva k.s.
|
| Revision |
13
|
| Date of issue of marketing authorisation valid throughout the European Union |
27/02/2017
|
| Contact address |
U Kabelovny 130
Dolni Mecholupy 102 37 Prague 10 Czech Republic |
Product information
23/02/2023 Pregabalin Zentiva k.s. - EMEA/H/C/004277 - IB/0022/G
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 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.