MSN-LURASIDONE (Accelagen Pty Ltd)

Product name

MSN-LURASIDONE

Date registered

17 March 2020

Evaluation commenced

1 July 2019

Decision date

13 March 2020

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