Prometax

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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 Prometax. 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 Prometax.

This EPAR was last updated on 17/11/2022

Authorisation details

Product details
Name
Prometax
Agency product number
EMEA/H/C/000255
Active substance
rivastigmine
International non-proprietary name (INN) or common name
rivastigmine
Therapeutic area (MeSH)
  • Alzheimer Disease
  • Parkinson Disease
  • Dementia
Anatomical therapeutic chemical (ATC) code
N06DA03
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
43
Date of issue of marketing authorisation valid throughout the European Union
03/12/1998
Contact address

Vista Building
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

14/11/2022 Prometax - EMEA/H/C/000255 - IG/1550/G

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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