Tasmar
tolcapone
Table of contents
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).
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 |
Viatris Healthcare Limited
|
Revision |
24
|
Date of issue of marketing authorisation valid throughout the European Union |
27/08/1997
|
Contact address |
Viatris Healthcare Limited |
Product information
21/11/2022 Tasmar - EMEA/H/C/000132 - T/0066
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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
-
Anti-Parkinson drugs
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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.