Overview

The marketing authorisation for Pregabalin Sandoz GmbH has been withdrawn at the request of the marketing-authorisation holder.

Pregabalin Sandoz GmbH : EPAR - Summary for the public

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Pregabalin Sandoz GmbH : EPAR - Risk-management-plan summary

Product information

Pregabalin Sandoz GmbH : EPAR - Product Information

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Latest procedure affecting product information: IA/0032

21/09/2023

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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).

Pregabalin Sandoz GmbH : EPAR - All Authorised presentations

български (BG) (438.87 KB - PDF)
español (ES) (297.21 KB - PDF)
čeština (CS) (302.59 KB - PDF)
dansk (DA) (290.29 KB - PDF)
Deutsch (DE) (283.09 KB - PDF)
eesti keel (ET) (280.05 KB - PDF)
ελληνικά (EL) (405.57 KB - PDF)
français (FR) (303.81 KB - PDF)
hrvatski (HR) (283.06 KB - PDF)
íslenska (IS) (294.11 KB - PDF)
italiano (IT) (288.53 KB - PDF)
latviešu valoda (LV) (394.11 KB - PDF)
lietuvių kalba (LT) (378.08 KB - PDF)
magyar (HU) (400.77 KB - PDF)
Malti (MT) (303.15 KB - PDF)
Nederlands (NL) (287.18 KB - PDF)
norsk (NO) (270.21 KB - PDF)
polski (PL) (333 KB - PDF)
português (PT) (281.75 KB - PDF)
română (RO) (299.41 KB - PDF)
slovenčina (SK) (300.86 KB - PDF)
slovenščina (SL) (391.62 KB - PDF)
Suomi (FI) (383.22 KB - PDF)
svenska (SV) (261.71 KB - PDF)

Product details

Name of medicine
Pregabalin Sandoz GmbH
Active substance
pregabalin
International non-proprietary name (INN) or common name
pregabalin
Therapeutic area (MeSH)
  • Anxiety Disorders
  • Epilepsy
Anatomical therapeutic chemical (ATC) code
N03AX16

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.

Authorisation details

EMA product number
EMEA/H/C/004070

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.

Marketing authorisation holder
Sandoz GmbH

Biochemiestr. 10
6250 Kundl
Austria

Opinion adopted
23/04/2015
Marketing authorisation issued
19/06/2015
Revision
16

Assessment history

Pregabalin Sandoz GmbH : EPAR - Procedural steps taken and scientific information after authorisation

Pregabalin Sandoz GmbH : EPAR - Public assessment report

CHMP summary of positive opinion for Pregabalin Sandoz GmbH

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