CLARISCAN (GE Healthcare Australia Pty Ltd)
Product name
CLARISCAN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
161 working days (255)
Active ingredients
gadoteric acid
Registration type
New generic medicine
Indication
CLARISCAN (solution for injection) is indicated, in adults and children, for use with magnetic resonance imaging to provide contrast enhancement for intracranial and spinal lesions with abnormal blood brain barrier or abnormal vascularity, and for whole body imaging.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine