RISPERIDONE
Information current as at: 1 July 2026
The pharmaceutical company has not advised whether they intend to proceed or not within 60 days of receiving the ratified PBAC minutes. The process for listing is considered inactive.
Submission Details
- Brand name:
-
- Uzedy®
- Form and strength:
-
Please search for and view the meeting agenda from the relevant meeting for more information
- Submission sponsor:
- TEVA PHARMA AUSTRALIA PTY LTD
- Condition/indication:
(therapeutic use) -
- Schizophrenia
- Listing requested:
- Please see meeting agenda for more information
- Funding program:
- PBS General Schedule
- Request authority level:
- Please see meeting agenda for more information
- PBAC Submission type:
- New PBS listing (Category 2)
- Comment:
- --
- Other PBAC consideration:
- --
Progress Details
-
Submission received for: - March 2026 PBAC meeting
-
Opportunity for consumer comment: - Open 19/11/2025 and close 21/01/2026 (see PBS Website)
-
PBAC meeting: - Held on 11/03/2026
-
PBAC outcome published: - Recommended (see PBAC Outcomes)
-
Notice of intent submitted:
- Awaiting lodgement from pharmaceutical company
-
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 Outcome
The PBAC recommended the listing of a long acting (modified release (MR)) subcutaneous (SC) injectable form of risperidone for the treatment of adult patients with schizophrenia. The PBAC welcomed input from health care professionals and a joint letter from organisations. The PBAC agreed that the introduction of MRSC risperidone may support more consistent use of antipsychotic therapy for patients with schizophrenia.
The PBAC considered that MRSC risperidone had similar safety and effectiveness to paliperidone 1 monthly (PP1M) long acting injection (LAI) and aripiprazole 1 monthly (A1M) LAI. The PBAC also considered MRSC risperidone had similar safety and effectiveness to risperidone 2 weekly intramuscular LAI, and risperidone 4 weekly intramuscular LAI.
The PBAC considered MRSC risperidone 75 mg administered once monthly to be equi‑effective to PP1M 37.5 mg once monthly and A1M 352 mg once monthly. The PBAC advised that the cost of MRSC would be acceptable if the overall cost was not higher than the lowest cost LAI antipsychotic therapy of aripiprazole, paliperidone, or risperidone.