Regulatory PathRegulatory requirements compared

Active substance

Tolcapone

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
TASMAR100MG; 200MGtablet · oralBAUSCHDiscontinued29 Jan 1998
TOLCAPONE100MGtablet · oralPH HEALTHDiscontinued26 Mar 2015
TOLCAPONE100MGtablet · oralINGENUS PHARMS LLCDiscontinued7 Aug 2018
TOLCAPONE100MGtablet · oralDR REDDYS LABS SADiscontinued1 Aug 2019
TOLCAPONE100MGtablet · oralALVOGENDiscontinued29 Jul 2020

EMA European Union — centrally authorised medicines

Tasmar Viatris Healthcare Limited · Authorised · authorised 27 Aug 1997 · ATC N04BX01

Therapeutic indication (EMA)

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.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffTolcapone 100mg tablets£95.20100 tablet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.