NUSINERSEN

Brand name:

• Spinraza®

Form and strength:

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

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 listing (Major)

Comment:

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Submission sponsor:

Biogen Australia Pty Ltd

Other PBAC consideration:

• NUSINERSEN
• NUSINERSEN

Submission received for:

July 2020 PBAC meeting

Opportunity for consumer comment:

Open 29/04/2020 and close 10/06/2020 (see PBS Website)

PBAC meeting:

Held on 08/07/2020

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

13/08/2020

Lodgement of required documentation:

11/09/2020

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 26/10/2020

Status:

Finalised

Government processes:

Commenced on 28/11/2020

Medicine listed on the PBS:

01/12/2020 (see PBS schedule)

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