ONASEMNOGENE ABEPARVOVEC

Brand name:

• Zolgensma®

Form and strength:

Please search for and view the medicine's Public Summary Document (PSD) for more information

Submission sponsor:

NOVARTIS PHARMACEUTICALS AUSTRALIA PTY LIMITED

Condition/indication:
(therapeutic use)

• Spinal muscular atrophy (SMA)

Listing requested:

Please see PSD for more information

Funding program:

Please see PSD for more information

Request authority level:

Please see PSD for more information

PBAC Submission type:

Change to existing listing (–)

Comment:

--

Other PBAC consideration:

--

Submission received for:

November 2025 PBAC meeting

Opportunity for consumer comment:

Open 30/07/2025 and close 24/09/2025 (see PBS Website)

PBAC meeting:

Held on 05/11/2025

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

12/03/2026

Lodgement of required documentation:

08/04/2026

Acceptance of complete documentation:

Accepted

6Agreement to listing arrangements:

Commenced on 11/05/2026

Status:

Under consideration

7Government processes:

Has not yet commenced

8Medicine listed on the PBS:

Has not yet occurred