BUROSUMAB

Brand name:

• Crysvita®

Form and strength:

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

Submission sponsor:

Kyowa Kirin Australia Pty Ltd

Condition/indication:
(therapeutic use)

• X-linked hypophosphataemia

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 (–)

Comment:

--

Other PBAC consideration:

• BUROSUMAB

Submission received for:

May 2022 PBAC meeting

Opportunity for consumer comment:

Open 24/11/2021 and close 27/01/2022 (see PBS Website)

PBAC meeting:

Held on 06/05/2022

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

03/06/2022

Lodgement of required documentation:

01/07/2022

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 29/07/2022

Status:

Finalised

Government processes:

Commenced on 19/08/2022

Medicine listed on the PBS:

01/11/2022 (see PBS schedule)