NUSINERSEN

Brand name:

• Spinraza®

Pharmaceutical company:

Biogen Australia Pty Ltd

Condition/indication:
(therapeutic use)

• Spinal muscular atrophy (SMA)

PBAC Submission type:

Change to listing (Major)

Comment:

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Public Summary Document:

PBAC Public Summary Documents – July 2020

Related medicines:

• 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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