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MSN-LURASIDONE (Accelagen Pty Ltd)
Product name
MSN-LURASIDONE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
131 working days (255)
Active ingredients
lurasidone hydrochloride
Registration type
New generic medicine
Indication
MSN-LURASIDONE (film-coated tablet) is indicated for the treatment of schizophrenia in adults and adolescents (aged 13 to 17 years).
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine