CLOZAPINE
Information current as at: 1 September 2026
Submission Details
- Brand name:
-
- Clozaril®
- Form and strength:
-
- Tablet 12.5mg (orally disintegrating)
- Tablet 25mg (orally disintegrating)
- Tablet 50mg (orally disintegrating)
- Tablet 100mg (orally disintegrating)
- Tablet 200mg (orally disintegrating)
- Submission sponsor:
- VIATRIS PTY LTD
- Condition/indication:
(therapeutic use) -
- Schizophrenia
- Listing requested:
- To request listing of new orally disintegrating tablet forms of clozapine for the treatment of patients with schizophrenia under the same restrictions as the currently listed tablet forms.
- Funding program:
- PBS Section 100 (Highly Specialised Drugs Program)
- Request authority level:
- Authority Required (STREAMLINED)
- PBAC Submission type:
- New PBS listing (Category 4)
- Comment:
- --
- Other PBAC consideration:
- --
Progress Details
-
Submission received for: - July 2026 PBAC meeting
-
Opportunity for consumer comment: - Open 25/03/2026 and close 20/05/2026 (see PBS Website)
-
PBAC meeting: - Held on 08/07/2026
-
5Lodgement of required documentation:
- 12/08/2026
-
Acceptance of complete documentation:
- Under consideration
-
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 listing Clozaril ODT® on the PBS for the treatment of schizophrenia in patients who are non-responsive to, or unable to tolerate, other antipsychotic medicines. Clozaril ODT® is an orally disintegrating tablet form of clozapine. The PBAC noted that the requested listings were consistent with the current PBS restrictions for clozapine. The PBAC also noted the introduction of a 12.5 mg strength ODT form and considered that the new formulation would provide an alternative dosage form without changing the eligible patient population or overall use of clozapine. The PBAC advised that Clozaril ODT® should be treated as interchangeable on an individual patient basis with other clozapine oral tablets.