CLOBIUM, PHARMACOR CLOBAZAM (Pharmacor Pty Ltd)
Product name
CLOBIUM, PHARMACOR CLOBAZAM
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
143 working days (255)
Active ingredients
clobazam
Registration type
New generic medicine
Indication
CLOBIUM, PHARMACOR CLOBAZAM (uncoated tablet) is indicated for:
Adults
Short term use (up to one month) for the symptomatic management of acute anxiety and sleep disturbances associated with anxiety.
Children (4 years of age and over)
As adjunctive therapy in patients with partial refractory and Lennox-Gastaut epilepsy types who are not adequately stabilized with their current anticonvulsant therapy.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine