ARIPIPRAZOLE

Information current as at: 1 July 2026

PBAC meeting date: November 2026

Legend:

Completed N In progress

Not applicable N Yet to commence

Submission Details

Brand name:: Abilify Asimtufii®
Form and strength:: I.M. injection (modified release) 720 mg (as monohydrate) in 2.4 mL pre-filled syringe

I.M. injection (modified release) 960 mg (as monohydrate) in 3.2 mL pre-filled syringe
Submission sponsor:: LUNDBECK AUSTRALIA PTY LTD
Condition/indication: (therapeutic use): Schizophrenia
Listing requested:: To request a change to the existing listing of Abilify Asimtufii for the treatment of schizophrenia to remove the requirement for prior treatment with monthly long-acting injectable aripiprazole before initiating the every two months formulation in order to align with the current Therapeutic Goods Administration (TGA)-approved Product Information (PI).
Funding program:: PBS General Schedule
Request authority level:: Authority Required (STREAMLINED)
PBAC Submission type:: Change to existing listing (–)
Comment:: --
Other PBAC consideration:: --

Submission received for:: November 2026 PBAC meeting
2Opportunity for consumer comment:: Open 22/07/2026 and close 16/09/2026 (see PBS Website)
3PBAC meeting:: Has not yet occurred
4PBAC outcome published:: Pending PBAC outcome (see PBAC Outcomes)
5Lodgement of required documentation:
6Agreement to listing arrangements:: Has not yet commenced
7Government processes:: Has not yet commenced
8Medicine listed on the PBS:: Has not yet occurred

PBAC Recommendation:

Please see the Outcomes from the relevant meeting for more information

Case ID

a1264

Page last updated

23 July 2026

v.9.19