NUSINERSEN

Brand name:

• Spinraza®

Pharmaceutical company:

BIOGEN AUSTRALIA PTY LTD

Condition/indication:
(therapeutic use)

• Pre-symptomatic spinal muscular atrophy (SMA)

PBAC Submission type:

Change to existing listing (–)

Comment:

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Public Summary Document:

PBAC Public Summary Documents – July 2023

Related medicines:

• NUSINERSEN
• NUSINERSEN

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:

27/09/2023

Lodgement of required documentation:

19/10/2023

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 17/11/2023

Status:

Finalised

Government processes:

Commenced on 19/12/2023

Medicine listed on the PBS:

01/03/2024 (see PBS schedule)

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