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VALOMEL/ RKM-AGOMELATINE/ AGODOXAN/ FGI-AGOMELATINE (Helix Pharmaceuticals Pty Ltd)
Product name
VALOMEL/ RKM-AGOMELATINE/ AGODOXAN/ FGI-AGOMELATINE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
140 (255 working days)
Active ingredients
agomelatine-citric acid
Registration type
New generic medicine
Indication
Treatment of major depressive disorder (MDD) in adults including prevention of relapse.