Pregabalin Zentiva k.s.

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pregabalin

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Pregabalin Zentiva k.s. has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 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)
  • Anxiety Disorders
  • Neuralgia
  • Epilepsy
Anatomical therapeutic chemical (ATC) code
N03AX16
GenericGeneric

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

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Product information documents contain:

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.

Assessment history

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