AGOMELATINE ANS, AGOMELATINE SANDOZ, AGOMELATINE SCP, APO-AGOMELATINE, BLOOMS THE CHEMIST AGOMELATINE (Southern Cross Pharma Pty Ltd)
Product name
AGOMELATINE ANS, AGOMELATINE SANDOZ, AGOMELATINE SCP, APO-AGOMELATINE, BLOOMS THE CHEMIST AGOMELATINE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
153 working days (255)
Active ingredients
agomelatine
Registration type
New generic medicine
Indication
AGOMELATINE ANS, AGOMELATINE SANDOZ, AGOMELATINE SCP, APO-AGOMELATINE, BLOOMS THE CHEMIST AGOMELATINE (film-coated tablet) is indicated for the treatment of major depression in adults including prevention of relapse.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine