Tasmar

RSS

tolcapone

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 of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 05/09/2018

Authorisation details

Product details
Name
Tasmar
Agency product number
EMEA/H/C/000132
Active substance
tolcapone
International non-proprietary name (INN) or common name
tolcapone
Therapeutic area (MeSH)
Parkinson Disease
Anatomical therapeutic chemical (ATC) code
N04BX01
Publication details
Marketing-authorisation holder
Meda AB
Revision
22
Date of issue of marketing authorisation valid throughout the European Union
27/08/1997
Contact address
Pipers väg 2A
SE-Solna 170 09
Sweden

Product information

08/08/2018 Tasmar - EMEA/H/C/000132 - IB/0060

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

  • Anti Parkinson drugs
  • Other dopaminergic agents

Therapeutic indication

Tasmar is indicated in combination with levodopa / benserazide or levodopa / carbidopa for use in patients with levodopa-responsive idiopathic Parkinson’s disease and motor fluctuations, who failed to respond to or are intolerant of other catechol-O-methyltransferase (COMT) inhibitors.

Because of the risk of potentially fatal, acute liver injury, Tasmar should not be considered as a first-line adjunct therapy to levodopa / benserazide or levodopa / carbidopa.

Since Tasmar should be used only in combination with levodopa / benserazide and levodopa / carbidopa, the prescribing information for these levodopa preparations is also applicable to their concomitant use with Tasmar.

Assessment history

How useful was this page?

Add your rating