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)

• Presymptomatic treatment of 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:

• ONASEMNOGENE ABEPARVOVEC

Submission received for:

July 2023 PBAC meeting

Opportunity for consumer comment:

Open 29/03/2023 and close 24/05/2023 (see PBS Website)

PBAC meeting:

Held on 05/07/2023

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

18/08/2023

Lodgement of required documentation:

05/09/2023

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 12/09/2023

Status:

Finalised

Government processes:

Commenced on 12/09/2023

Medicine listed on the PBS:

01/10/2023 (see PBS schedule)