EMA — authorised 23 July 2007
- Status: approved
🇪🇺 Optimark in European Union
EMA authorised Optimark on 23 July 2007
Marketing authorisations
EMA — authorised 23 July 2007
- Application: EMEA/H/C/000745
- Marketing authorisation holder: Mallinckrodt Deutschland GmbH
- Local brand name: Optimark
- 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.
- Status: withdrawn
Optimark in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in European Union
Frequently asked questions
Is Optimark approved in European Union?
Yes. EMA authorised it on 23 July 2007; EMA authorised it on 23 July 2007.
Who is the marketing authorisation holder for Optimark in European Union?
Liebel-Flarsheim is the originator. The local marketing authorisation holder may differ — check the official source linked above.