EDARAVONE

Brand name:

• Radicava®

Pharmaceutical company:

Teva Pharma Australia Pty Ltd

Condition/indication:
(therapeutic use)

• Amyotrophic lateral sclerosis (ALS)

PBAC Submission type:

New listing (Early Re-entry Pathway)

Comment:

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Public Summary Document:

PBAC Public Summary Documents – March 2024

Related medicines:

• EDARAVONE

Submission received for:

March 2024 PBAC meeting

Opportunity for consumer comment:

Open 22/11/2023 and close 31/01/2024 (see PBS Website)

PBAC meeting:

Held on 13/03/2024

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

22/05/2024

Lodgement of required documentation:

31/05/2024

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 06/12/2024

Status:

Finalised

Government processes:

Commenced on 19/12/2024

Medicine listed on the PBS:

01/05/2025 (see PBS schedule)

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