IPTACOPAN

Information current as at: 1 April 2025

Legend: Completed N In progress Not applicable N Yet to commence

Submission Details

Brand name:
  • Fabhalta®
Pharmaceutical company:
NOVARTIS PHARMACEUTICALS AUSTRALIA PTY LIMITED
Condition/indication:
(therapeutic use)
  • Paroxysmal nocturnal hemoglobinuria (PNH)
PBAC Submission type:
New PBS listing (Category 1)
Comment:
--
Related medicines:
--

Progress Details

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
5Lodgement of required documentation:
23/01/2025
Acceptance of complete documentation:
Under consideration
6Agreement to listing arrangements:
Has not yet commenced
7Government processes:
Has not yet commenced
8Medicine listed on the PBS:
Has not yet occurred

Case ID: a884

Page last updated: 07 February 2025

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