RILUZOLE
Information current as at: 1 July 2026
Submission Details
- Brand name:
-
- Teglutik®
- Form and strength:
-
Please search for and view the meeting agenda from the relevant meeting for more information
- Submission sponsor:
- ASTERI PHARMA PTY LTD
- Condition/indication:
(therapeutic use) -
- Amyotrophic lateral sclerosis
- 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 listing (Category 4)
- 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: - Advice Provided (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 Outcome
The PBAC advised that riluzole oral suspension 50 mg per 10 mL, 300 mL (Teglutik®) can be considered as an exempt item under section 84AH of the National Health Act 1953 on the basis that the oral suspension form of riluzole is the only suitable option for patients for whom the PBS-listed tablet form is unsuitable due to difficulties in swallowing. The PBAC considered that no other PBS listed product is bioequivalent, biosimilar or ‘a’ flagged to riluzole oral suspension, and noted there were no alternative brands of the riluzole oral suspension.