PALIPERIDONE-TEVA (Teva Pharma Australia Pty Ltd)

Product name

PALIPERIDONE-TEVA

Date registered

5 June 2024

Evaluation commenced

28 February 2023

Decision date

22 May 2024

Approval time

160 (255 working days)

Active ingredients

paliperidone palmitate

Registration type

New generic medicine

Indication

PALIPERIDONE-TEVA is indicated for the acute and maintenance treatment of schizophrenia in adults.

Registration process

First generic

First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine