Rivastigmine Actavis

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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 Rivastigmine Actavis. 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 Rivastigmine Actavis.

This EPAR was last updated on 14/05/2018

Authorisation details

Product details
Name
Rivastigmine Actavis
Agency product number
EMEA/H/C/002036
Active substance
rivastigmine hydrogen tartrate
International non-proprietary name (INN) or common name
rivastigmine
Therapeutic area (MeSH)
  • Dementia
  • Alzheimer Disease
  • Parkinson Disease
Anatomical therapeutic chemical (ATC) code
N06DA03
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 medicines.

Publication details
Marketing-authorisation holder
Actavis Group PTC ehf
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
16/06/2011
Contact address
Reykjavíkurvegur 76 - 78
IS-220 Hafnarfjörður
Iceland

Product information

04/04/2018 Rivastigmine Actavis - EMEA/H/C/002036 - N/0023

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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