AMINO ACID FORMULA WITH VITAMINS AND MINERALS WITHOUT LYSINE AND LOW IN TRYPTOPHAN
Information current as at: 1 September 2026
Submission Details
- Brand name:
-
- GA1 Anamix Infant®
- GA1 Anamix Junior®
- Form and strength:
-
- Oral powder 400 g (GA1 Anamix infant)
- Sachets containing oral powder 18 g, 30 (GA1 Anamix Junior)
- Submission sponsor:
- NUTRICIA AUSTRALIA PTY LTD
- Condition/indication:
(therapeutic use) -
- Pyridoxine‑Dependent Epilepsy (PDE)
- Listing requested:
- To request listing of GA1 Anamix Infant and GA1 Anamix Junior for the dietary management of infants and children diagnosed with PDE who require a lysine-free, arginine-supplemented amino-acid formula in combination with pyridoxine.
- Funding program:
- PBS General Schedule
- Request authority level:
- Restricted Benefit
- PBAC Submission type:
- Change to existing listing (Committee Secretariat)
- 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
-
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 extending the current General Schedule Restricted Benefit listings for amino acid formula with vitamins and minerals without lysine and low in tryptophan (Glutaric Aciduria Type 1 (GA1) Anamix Infant and GA1 Anamix Junior) to include use in pyridoxine‑dependent epilepsy (PDE) deficiency.
The PBAC noted and supported advice from the Nutritional Products Working Party that these products are clinically appropriate for the dietary management of PDE deficiency.
The PBAC noted that only a small patient population in Australia is likely to require dietary management of PDE deficiency. The PBAC considered the estimated financial impact of the proposed listing extension was appropriate.