DAUNORUBICIN WITH CYTARABINE

Brand name:

• Vyxeos®

Form and strength:

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

Submission sponsor:

Jazz Pharmaceuticals ANZ Pty Ltd

Condition/indication:
(therapeutic use)

• Acute myeloid leukaemia

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:

New listing (Early Re-entry Pathway)

Comment:

--

Other PBAC consideration:

• DAUNORUBICIN WITH CYTARABINE
• DAUNORUBICIN WITH CYTARABINE

Submission received for:

November 2023 PBAC meeting

Opportunity for consumer comment:

Open 26/07/2023 and close 20/09/2023 (see PBS Website)

PBAC meeting:

Held on 01/11/2023

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

01/02/2024

Lodgement of required documentation:

08/02/2024

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 30/04/2024

Status:

Finalised

Government processes:

Commenced on 07/05/2024

Medicine listed on the PBS:

01/07/2024 (see PBS schedule)