ALEMBIC LURASIDONE, APO-LURASIDONE, BILURA, LATULEM, LURALEM, LURALEMBIC, LURASIDONE AGH, LURASIDONE AGHL, LURASIDONE APL, LURASIDONE APPL, LURASIDONE SANDOZ, LUROBI (Alembic Pharmaceuticals Australia Pty Ltd)
Product name
ALEMBIC LURASIDONE, APO-LURASIDONE, BILURA, LATULEM, LURALEM, LURALEMBIC, LURASIDONE AGH, LURASIDONE AGHL, LURASIDONE APL, LURASIDONE APPL, LURASIDONE SANDOZ, LUROBI
Date registered
Evaluation commenced
Decision date
Approval time
156 working days (255)
Active ingredients
lurasidone hydrochloride
Registration type
New generic medicine
Indication
ALEMBIC LURASIDONE, APO-LURASIDONE, BILURA, LATULEM, LURALEM, LURALEMBIC, LURASIDONE AGH, LURASIDONE AGHL, LURASIDONE APL, LURASIDONE APPL, LURASIDONE SANDOZ, LUROBI (film-coated tablet) are indicated for the treatment of schizophrenia in adults and adolescents (aged 13 to 17 years).