Pregabalin Zentiva k.s.
This is a summary of the European public assessment report (EPAR) for Pregabalin Zentiva k.s. 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 Zentiva k.s.
For practical information about using Pregabalin Zentiva k.s., patients should read the package leaflet or contact their doctor or pharmacist.
Pregabalin Zentiva k.s. : EPAR - Summary for the public (PDF/122.07 KB)
First published: 06/03/2017
Last updated: 06/03/2017
Pregabalin Zentiva k.s. : EPAR - Risk management plan summary (PDF/134.82 KB)
First published: 05/05/2022
Pregabalin Zentiva k.s.
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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.
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U Kabelovny 130
Dolni Mecholupy 102 37
17/11/2022 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.
- Pregabalin Zentiva k.s. is indicated for the treatment of peripheral and central neuropathic pain in adults.
- 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.