Rivastigmine 1 A Pharma

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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 26/01/2022

Authorisation details

Product details
Name
Rivastigmine 1 A Pharma
Agency product number
EMEA/H/C/001181
Active substance
rivastigmine
International non-proprietary name (INN) or common name
rivastigmine
Therapeutic area (MeSH)
  • Alzheimer Disease
  • Dementia
  • Parkinson Disease
Anatomical therapeutic chemical (ATC) code
N06DA03
Publication details
Marketing-authorisation holder
1 A Pharma GmbH
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
11/12/2009
Contact address
Keltenring 1 + 3
D-82041 Oberhaching
Germany

Product information

26/01/2022 Rivastigmine 1 A Pharma - EMEA/H/C/001181 - IAIN/0034

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).

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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