RAVULIZUMAB

Brand name:

• Ultomiris®

Form and strength:

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

Submission sponsor:

Alexion Pharmaceuticals Australasia Pty Ltd

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:

New listing (Resubmission)

Comment:

--

Other PBAC consideration:

• RAVULIZUMAB

Submission received for:

July 2021 PBAC meeting

Opportunity for consumer comment:

Open 21/03/2021 and close 26/05/2021 (see PBS Website)

PBAC meeting:

Held on 07/07/2021

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

01/10/2021

Lodgement of required documentation:

20/10/2021

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 27/10/2021

Status:

Finalised

Government processes:

Commenced on 19/01/2022

Medicine listed on the PBS:

01/03/2022 (see PBS schedule)