Guerbet and Bracco Received Positive Opinion from EU’s CHMP for Elucirem & Vueway (Gadopiclenol)
Shots:
- The positive opinion was adopted based on 2 P-III Clinical trials (PICTURE) & (PROMISE) evaluating efficacy & safety for Elucirem & Vueway, MRI with contrast enhancement in adults & children aged 2yrs. & over
- The result of the study demonstrated thatGadopiclenol provided non-inferior outcomes in brain & whole body. The evaluation criteria were met with Gadopiclenol (0.05 mmol/kg) injection which includes the superiority of using a contrast product in an examination over one without & the non-inferiority of Gadopiclenol (0.05 mmol/kg) vs Gadobutrol (0.1 mmol/kg)
- Gadopiclenol is a novel macrocyclic gadolinium-based contrast agent (GBCA) with excellent relaxivity. Its efficacy and safety have been assessed in MRI scans of the musculoskeletal system, head, neck, thorax, abdomen, and pelvis
Ref: Guerbet | Image: Guerbet
Related News:- Guerbet’s Elucirem (gadopiclenol) Receives the US FDA’s Approval for Contrast-Enhanced Magnetic Resonance Imaging
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
