Elucirem (gadopiclenol)
- Region
- 🇪🇺 EU
- Active substance
- gadopiclenol
- Company
- Guerbet
- Status
- Authorised
- Therapeutic area
- Magnetic Resonance Imaging
- CHMP opinion
- Thu 12 Oct 2023
- EU approval
- Thu 07 Dec 2023
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005626
- ATC
- V08CA12
- Official record
- www.ema.europa.eu
Indication
This medicinal product is for diagnostic use only.Elucirem is indicated in adults and children from birth for contrast-enhanced magnetic resonance imaging (MRI) to improve detection and visualization of pathologies with disruption of the blood-brain-barrier (BBB) and/or abnormal vascularity of:- the brain, spine, and associated tissues of the central nervous system (CNS);- the liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system.It should be used only when diagnostic information is essential and not available with unenhanced MRI.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Vueway Authorised · Bracco Imaging S.p.A.
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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.