Rivastigmine 3M Health Care Ltd

Withdrawn

This medicine's authorisation has been withdrawn

rivastigmine

Overview

The marketing authorisation for Rivastigmine 3M Health Care Ltd has been withdrawn at the request of the marketing authorisation holder.

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

19/08/2014

This medicine’s product information is available in all official EU languages.
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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).

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
• Revision:
  1

Assessment history

Initial marketing authorisation documents

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

AdoptedReference Number: EMA/111203/2014

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

AdoptedReference Number: EMA/CHMP/25190/2014