Rivastigmine Teva

Withdrawn

This medicine's authorisation has been withdrawn

rivastigmine

Overview

On the 17 April 2009 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Rivastigmine Teva (Rivastigmine) which was approved for the symptomatic treatment of patients with mild to moderately severe Alzheimer’s dementia and symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson’s disease. The marketing authorisation holder (MAH) responsible for Rivastigmine Teva was Teva Pharma B.V. 

The European Commission was notified by a letter dated 24 August 2012 of the MAH’s decision to voluntarily withdraw the marketing authorisation as of the Commission Decision date for Rivastigmine Teva for commercial reasons. Rivastigmine Teva was only marketed in Romania. On 10 September 2012 the European Commission issued a decision to withdraw the marketing authorisation for Rivastigmine Teva. 

Pursuant to this decision the European Public Assessment Report for Rivastigmine Teva is updated to reflect that the marketing authorisation is no longer valid.

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
• Withdrawal of marketing authorisation:
  10/09/2012
• 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