Rivastigmine Hexal

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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). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 02/08/2019

Authorisation details

Product details
Name
Rivastigmine Hexal
Agency product number
EMEA/H/C/001182
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
Hexal AG 
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
11/12/2009
Contact address
Hexal AG
Industriestrasse 25
D-83607 Holzkirchen
Germany

Product information

18/10/2018 Rivastigmine Hexal - EMEA/H/C/001182 - N/0025

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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