ELEXACAFTOR WITH TEZACAFTOR AND WITH IVACAFTOR, AND IVACAFTOR

Brand name:

• Trikafta®

Form and strength:

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

Submission sponsor:

VERTEX PHARMACEUTICALS (AUSTRALIA) PTY. LTD.

Condition/indication:
(therapeutic use)

• Cystic fibrosis

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 (–)

Comment:

No further action, please see ELEXACAFTOR WITH TEZACAFTOR AND WITH IVACAFTOR, AND IVACAFTOR link in Related medicines below.

Other PBAC consideration:

• ELEXACAFTOR WITH TEZACAFTOR AND WITH IVACAFTOR, AND IVACAFTOR

Submission received for:

November 2022 PBAC meeting

Opportunity for consumer comment:

Open 27/07/2022 and close 21/09/2022 (see PBS Website)

PBAC meeting:

Held on 02/11/2022

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

22/12/2022

Lodgement of required documentation:

20/01/2023

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Not applicable

Government processes:

Not applicable

Medicine listed on the PBS:

Not applicable