<p>The marketing authorisation for Optimark (gadoversetamide) expired on 25 July 2017 following the decision of the marketing authorisation holder, Guerbet, not to apply for a renewal of the marketing authorisation. </p><p>Optimark was granted marketing authorisation in the European Union (EU) on 23 July 2007 for use with magnetic resonance imaging (MRI) of the central nervous system and the liver. The marketing authorisation was valid for a 5-year period. It was subsequently renewed for an additional 5-year period in 2012. </p><p>The European Public Assessment Report (EPAR) for Optimark is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.</p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p>This medicinal product is for diagnostic use only.</p> <p>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.</p></div>
Therapeutic Area (MeSH)
ATC Code
V08CA06
ATC Item
N/A
Pharmacotherapeutic Group
Contrast media
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| gadoversetamide | N/A | gadoversetamide |
EMA Name
Optimark
Medicine Name
Optimark
Aliases
N/ANo risk management plan link.
