Exelon

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rivastigmine

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Exelon. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Exelon.

This EPAR was last updated on 14/11/2018

Authorisation details

Product details
Name
Exelon
Agency product number
EMEA/H/C/000169
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
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
37
Date of issue of marketing authorisation valid throughout the European Union
11/05/1998
Contact address

Elm Park, Merrion Road
Dublin 4
Ireland

Product information

23/04/2018 Exelon - EMEA/H/C/000169 - T/0118

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Psychoanaleptics

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.

Assessment history

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