PEGCETACOPLAN

Brand name:

• Empaveli®

Form and strength:

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

Condition/indication:
(therapeutic use)

• Paroxysmal nocturnal haemoglobinuria (PNH)

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 (Category 2)

Comment:

--

Submission sponsor:

SWEDISH ORPHAN BIOVITRUM PTY LTD

Other PBAC consideration:

--

Submission received for:

May 2025 PBAC meeting

Opportunity for consumer comment:

Open 30/01/2025 and close 26/03/2025 (see PBS Website)

PBAC meeting:

Held on 09/05/2025

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

13/06/2025

Lodgement of required documentation:

23/06/2025

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 10/10/2025

Status:

Finalised

Government processes:

Commenced on 10/10/2025

Medicine listed on the PBS:

01/12/2025 (see PBS schedule)

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