Rivastigmine Teva

Withdrawn

This medicine's authorisation has been withdrawn

rivastigmine

Overview

The marketing authorisation for Rivastigmine Teva has been withdrawn at the request of the marketing-authorisation holder.

Rivastigmine Teva : EPAR - Summary for the public

Product information

Rivastigmine Teva : EPAR - Product Information

Rivastigmine Teva : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Rivastigmine Teva
• Active substance:
  rivastigmine
• International non-proprietary name (INN) or common name:
  rivastigmine
• Therapeutic area (MeSH):
  • Dementia
  • Alzheimer Disease
  • Parkinson Disease
• Anatomical therapeutic chemical (ATC) code:
  N06DA03

Pharmacotherapeutic group

Anticholinesterases

Therapeutic indication

Symptomatic treatment of mild to moderately severe Alzheimer's dementia.

Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.

Authorisation details

• EMA product number:
  EMEA/H/C/001044
• 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:
  Teva Pharma B.V.

  Computerweg 10; NL-3542 DR Utrecht; The Netherlands

• Marketing authorisation issued:
  17/04/2009
• Revision:
  4

Assessment history

Changes since initial authorisation of medicine

Rivastigmine Teva : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Rivastigmine Teva : EPAR - Public assessment report

Committee for medicinal products for human use, summary of positive opinion for Rivastigmine Teva

Reference Number: EMEA/CHMP/100894/2009