DARATUMUMAB

Brand name:

• Darzalex®

Form and strength:

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

Condition/indication:
(therapeutic use)

• Multiple myeloma

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 (Standard Re-entry Pathway)

Comment:

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Submission sponsor:

JANSSEN-CILAG PTY LTD

Other PBAC consideration:

• DARATUMUMAB

Submission received for:

March 2025 PBAC meeting

Opportunity for consumer comment:

Open 27/11/2024 and close 29/01/2025 (see PBS Website)

PBAC meeting:

Held on 12/03/2025

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

17/06/2025

Lodgement of required documentation:

01/07/2025

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 06/08/2025

Status:

Finalised

Government processes:

Commenced on 14/08/2025

Medicine listed on the PBS:

01/11/2025 (see PBS schedule)

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