Rivastigmine 3M Health Care Ltd

Withdrawn

This medicine's authorisation has been withdrawn

rivastigmine

Overview

On 19 August 2014, the European Commission withdrew the marketing authorisation for Rivastigmine 3M Health Care Ltd (rivastigmine, transdermal patches) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, 3M Health Care Ltd, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Rivastigmine 3M Health Care Ltd was granted marketing authorisation in the EU on 3 April 2014 for the treatment of mild to moderately severe Alzheimer’s dementia. 

Rivastigmine 3M Health Care Ltd is a generic medicine of Exelon. There are other generic medicinal products of Exelon authorised and marketed in the EU. Rivastigmine 3M Health Care Ltd. is an identical product to Rivastigmine Actavis (transdermal patches), which is authorised in the EU to treat patients with mild to moderately severe Alzheimer’s dementia. 

Rivastigmine 3M Health Care Ltd was a duplicate application to Rivastigmine Actavis Transdermal Patches. 

The European Public Assessment Report (EPAR) for Rivastigmine 3M Health Care Ltd is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Rivastigmine 3M Health Care Ltd : EPAR - Summary for the public

Reference Number: EMA/58565/2014

Rivastigmine 3M Health Care Ltd : EPAR - Risk-management-plan summary

Product information

Rivastigmine 3M Health Care Ltd : EPAR - Product Information

Rivastigmine 3M Health Care Ltd : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Rivastigmine 3M Health Care Ltd
• Active substance:
  rivastigmine
• International non-proprietary name (INN) or common name:
  rivastigmine
• Therapeutic area (MeSH):
  Alzheimer Disease
• Anatomical therapeutic chemical (ATC) code:
  N06DA03

Pharmacotherapeutic group

• Psychoanaleptics
• Anticholinesterases

Therapeutic indication

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

Authorisation details

• EMA product number:
  EMEA/H/C/003824
• 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:
  3M Health Care Limited

  1 Morley Street ; Loughborough ; Leicestershire LE11 1EP ; United Kingdom

• Opinion adopted:
  23/01/2014
• Marketing authorisation issued:
  03/04/2014
• Withdrawal of marketing authorisation:
  19/08/2014
• Revision:
  1

Assessment history

Initial marketing authorisation documents

Rivastigmine 3M Health Care Ltd : EPAR - Public assessment report

Adopted Reference Number: EMA/111203/2014

CHMP summary of positive opinion for Rivastigmine 3M Health Care Ltd

Adopted Reference Number: EMA/CHMP/25190/2014