United States - English - NLM (National Library of Medicine)

par pharmaceutical, inc. - tolcapone (unii: cif6334oly) (tolcapone - unii:cif6334oly) - tolcapone 100 mg - tolcapone tablets usp are indicated as an adjunct to levodopa and carbidopa for the treatment of the signs and symptoms of idiopathic parkinson’s disease. because of the risk of potentially fatal, acute fulminant liver failure, tolcapone tablets usp should ordinarily be used in patients with parkinson’s disease on l-dopa/carbidopa who are experiencing symptom fluctuations and are not responding satisfactorily to or are not appropriate candidates for other adjunctive therapies. because of the risk of liver injury and because tolcapone tablets usp, when it is effective, provides an observable symptomatic benefit, the patient who fails to show substantial clinical benefit within 3 weeks of initiation of treatment, should be withdrawn from tolcapone tablets usp. the effectiveness of tolcapone tablets usp was demonstrated in randomized controlled trials in patients receiving concomitant levodopa therapy with carbidopa or another aromatic amino acid decarboxylase inhibitor who experienced end of dose wearing-o

United States - English - NLM (National Library of Medicine)

oceanside pharmaceuticals - tolcapone (unii: cif6334oly) (tolcapone - unii:cif6334oly) - tolcapone 100 mg - tolcapone tablets is indicated as an adjunct to levodopa and carbidopa for the treatment of the signs and symptoms of idiopathic parkinson's disease. because of the risk of potentially fatal, acute fulminant liver failure, tolcapone tablets should ordinarily be used in patients with parkinson's disease on l-dopa/carbidopa who are experiencing symptom fluctuations and are not responding satisfactorily to or are not appropriate candidates for other adjunctive therapies. because of the risk of liver injury and because tolcapone tablets, when it is effective, provides an observable symptomatic benefit, the patient who fails to show substantial clinical benefit within 3 weeks of initiation of treatment, should be withdrawn from tolcapone tablets. the effectiveness of tolcapone tablets was demonstrated in randomized controlled trials in patients receiving concomitant levodopa therapy with carbidopa or another aromatic amino acid decarboxylase inhibitor who experienced end of dose wearing-off phenomena as well as in

United States - English - NLM (National Library of Medicine)

ingenus pharmaceuticals, llc - tolcapone (unii: cif6334oly) (tolcapone - unii:cif6334oly) - tolcapone tablets, usp is indicated as an adjunct to levodopa and carbidopa for the treatment of the signs and symptoms of idiopathic parkinson's disease. because of the risk of potentially fatal, acute fulminant liver failure, tolcapone tablets, usp should ordinarily be used in patients with parkinson's disease on l-dopa/carbidopa who are experiencing symptom fluctuations and are not responding satisfactorily to or are not appropriate candidates for other adjunctive therapies. because of the risk of liver injury and because tolcapone tablets, usp, when it is effective, provides an observable symptomatic benefit, the patient who fails to show substantial clinical benefit within 3 weeks of initiation of treatment, should be withdrawn from tolcapone tablets, usp. the effectiveness of tolcapone tablets, usp was demonstrated in randomized controlled trials in patients receiving concomitant levodopa therapy with carbidopa or another aromatic amino acid decarboxylase inhibitor who experienced end of dose wearing-of

United States - English - NLM (National Library of Medicine)

bausch health us llc - tolcapone (unii: cif6334oly) (tolcapone - unii:cif6334oly) - tolcapone 100 mg - tasmar is indicated as an adjunct to levodopa and carbidopa for the treatment of the signs and symptoms of idiopathic parkinson's disease. because of the risk of potentially fatal, acute fulminant liver failure, tasmar (tolcapone) should ordinarily be used in patients with parkinson's disease on l-dopa/carbidopa who are experiencing symptom fluctuations and are not responding satisfactorily to or are not appropriate candidates for other adjunctive therapies. because of the risk of liver injury and because tasmar, when it is effective, provides an observable symptomatic benefit, the patient who fails to show substantial clinical benefit within 3 weeks of initiation of treatment, should be withdrawn from tasmar. the effectiveness of tasmar was demonstrated in randomized controlled trials in patients receiving concomitant levodopa therapy with carbidopa or another aromatic amino acid decarboxylase inhibitor who experienced end of dose wearing-off phenomena as well as in patients who did not experience such pheno

New Zealand - English - Medsafe (Medicines Safety Authority)

inova pharmaceuticals (new zealand) limited - tolcapone 100mg - film coated tablet - 100 mg - active: tolcapone 100mg excipient: calcium hydrogen phosphate ethylcellulose hypromellose iron oxide yellow lactose monohydrate magnesium stearate microcrystalline cellulose povidone purified talc   sodium laurilsulfate sodium starch glycolate titanium dioxide triacetin - tasmar is indicated for use in combination with levodopa/benserazide and levodopa/carbidopa in parkinson's disease, including both fluctuating and non-fluctuating patients.

European Union - English - EMA (European Medicines Agency)

viatris healthcare limited - tolcapone - parkinson disease - anti-parkinson drugs, other dopaminergic agents - 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - tolcapone 200mg;   - film coated tablet - 200 mg - active: tolcapone 200mg  

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

meda pharmaceuticals ltd - tolcapone - tablet - 100mg

Canada - English - Health Canada

hoffmann-la roche limited - tolcapone - tablet - 100mg - tolcapone 100mg - catechol-o-methyltransferase (comt) inhibitors

Canada - English - Health Canada

hoffmann-la roche limited - tolcapone - tablet - 200mg - tolcapone 200mg - catechol-o-methyltransferase (comt) inhibitors