IPTACOPAN

Brand name:

• Fabhalta®

Form and strength:

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

Submission sponsor:

NOVARTIS PHARMACEUTICALS AUSTRALIA PTY LIMITED

Condition/indication:
(therapeutic use)

• Paroxysmal nocturnal hemoglobinuria (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 PBS listing (Category 1)

Comment:

--

Other PBAC consideration:

--

Submission received for:

July 2024 PBAC meeting

Opportunity for consumer comment:

Open 03/04/2024 and close 29/05/2024 (see PBS Website)

PBAC meeting:

Held on 10/07/2024

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

14/01/2025

Lodgement of required documentation:

23/01/2025

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 18/08/2025

Status:

Finalised

Government processes:

Commenced on 19/08/2025

Medicine listed on the PBS:

01/11/2025 (see PBS schedule)