(AOF) – The marketing authorization (AMM) for Elucirem (Gadopiclenol) was granted to Guerbet by the European Commission on the basis of the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued on October 12, 2023. The specialist in contrast products for medical imaging specifies that in the indications approved within the framework of this Marketing Authorization, an MRI examination with Elucirem requires half the dose of gadolinium compared to to existing non-specific contrast products
Invented, designed and manufactured by Guerbet, Elucirem has been approved by the FDA (Food and Drug Administration) since September 2022. It is produced in France and the United States. It will be marketed by Guerbet within the European Union in the form of vials and pre-filled syringes.
In the European Union, Elucirem is indicated in adults and children 2 years and older for contrast-enhanced MRI to improve the detection and visualization of pathologies with disruption of the blood-brain barrier (BBB) and/or or presenting abnormal vascularization.
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