Optimark (gadoversetamide)
- Region
- 🇪🇺 EU
- Active substance
- gadoversetamide
- Company
- Mallinckrodt Deutschland GmbH
- Status
- Withdrawn
- Therapeutic area
- Magnetic Resonance Imaging
- EU approval
- Mon 23 Jul 2007
- Application
- EMEA/H/C/000745
- ATC
- V08CA06
- Official record
- www.ema.europa.eu
Indication
This medicinal product is for diagnostic use only. Optimark is indicated for use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver. It provides contrast enhancement and facilitates visualisation and helps with the characterisation of focal lesions and abnormal structures in the CNS and liver in patients with known or highly suspected pathology.
Regulatory milestones
No milestones recorded in the last year.
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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.