TETRABENAZINE RAN/TETRABENAZINE SUN/TETRABENAZINE RBX (Sun Pharma ANZ Pty Ltd)
Product name
TETRABENAZINE RAN/TETRABENAZINE SUN/TETRABENAZINE RBX
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
127 (255 working days)
Active ingredients
Tetrabenazine
Registration type
New generic medicine
Indication
May be useful for the control of chorea, hemiballismus, tardive and buccolingualdyskinesias and certain dystonic syndromes.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine