PEGCETACOPLAN

Brand name:

• Empaveli™

Pharmaceutical company:

Swedish Orphan Biovitrum Pty Ltd

Condition/indication:
(therapeutic use)

• Paroxysmal nocturnal haemoglobinuria

PBAC Submission type:

New PBS listing (Early Re-entry Pathway)

Comment:

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Public Summary Document:

PBAC Public Summary Documents – July 2022

Related medicines:

• PEGCETACOPLAN

Submission received for:

July 2022 PBAC meeting

Opportunity for consumer comment:

Open 30/03/2022 and close 25/05/2022 (see PBS Website)

PBAC meeting:

Held on 06/07/2022

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

01/08/2022

Lodgement of required documentation:

15/08/2022

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 31/08/2022

Status:

Finalised

Government processes:

Commenced on 20/10/2022

Medicine listed on the PBS:

01/12/2022 (see PBS schedule)

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