Tasmar (tolcapone)
- Region
- 🇪🇺 EU
- Active substance
- tolcapone
- Company
- Viatris Healthcare Limited
- Status
- Authorised
- Therapeutic area
- Parkinson Disease
- EU approval
- Wed 27 Aug 1997
- Application
- EMEA/H/C/000132
- ATC
- N04BX01
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Follow Tasmar
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.