PEGUNIGALSIDASE ALFA

Brand name:

• Elfabrio®

Form and strength:

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

Submission sponsor:

CHIESI AUSTRALIA PTY LTD

Condition/indication:
(therapeutic use)

• Fabry disease

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 PBS listing (–)

Comment:

--

Other PBAC consideration:

--

Submission received for:

July 2025 PBAC meeting

Opportunity for consumer comment:

Open 02/04/2025 and close 28/05/2025 (see PBS Website)

PBAC meeting:

Held on 09/07/2025

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

13/08/2025

Lodgement of required documentation:

24/09/2025

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 12/06/2026

Status:

Finalised

7Government processes:

Commenced on 12/06/2026

8Medicine listed on the PBS:

Has not yet occurred