EPARs human use - Tasmar//tolcapone

FICHA FARMACOLÓGICA de tolcapone. Contiene la Monografía en distintos idiomas (de la Comunidad Económica Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Cerasale. JUNIO 04, 2009.-

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EPARs for authorised medicinal products for human use - Tasmar

Marketing Authorisation Holder
Meda AB
Pipers väg 2A
S-170 09 Solna
Sweden
Active Substance
tolcapone
International Nonproprietary Name or Common Name
tolcapone
Pharmaco-therapeutic Group
Anti-Parkinson drug
ATC Code
NO4 BX01

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 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. If substantial clinical benefits are not seen within 3 weeks of the initiation of the treatment, Tasmar should be discontinued.

Date of issue of Marketing Authorisation valid throughout the European Union
27 August 1997