IVACAFTOR

Brand name:

• Kalydeco®

Pharmaceutical company:

Vertex Pharmaceuticals (Australia) Pty. Ltd.

Condition/indication:
(therapeutic use)

• Cystic fibrosis (CF) with the CF transmembrane conductance regulator (CFTR) gene mutation

PBAC Submission type:

New listing (Category 2)

Comment:

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Public Summary Document:

PBAC Public Summary Documents – November 2023

Related medicines:

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Submission received for:

November 2023 PBAC meeting

Opportunity for consumer comment:

Open 26/07/2023 and close 20/09/2023 (see PBS Website)

PBAC meeting:

Held on 01/11/2023

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

12/12/2023

Lodgement of required documentation:

21/12/2023

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 27/03/2024

Status:

Finalised

Government processes:

Commenced on 08/04/2024

Medicine listed on the PBS:

01/06/2024 (see PBS schedule)

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