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ELUCIREM (Guerbet Australia Pty Ltd)
Product name
ELUCIREM
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
185 (255 working days)
Active ingredients
gadopiclenol
Registration type
NCE/ NBE
Indication
This medicinal product is for diagnostic use only.
[TRADE NAME] (gadopiclenol) is indicated in adults and children aged 2 years and older for contrast-enhanced magnetic resonance imaging (MRI) to detect and visualise lesions with abnormal blood brain barrier or abnormal vascularity in:
- the central nervous system (brain, spine, and associated tissues);
- the body (head and neck, thorax, abdomen, pelvis and musculoskeletal system).