ICOSAPENT ETHYL

Brand name:

• Vazkepa®

Form and strength:

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

Condition/indication:
(therapeutic use)

• Atherosclerotic cardiovascular disease with elevated triglycerides

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 (Early Re-entry Pathway)

Comment:

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Submission sponsor:

Seqirus (Australia) Pty Ltd

Other PBAC consideration:

• ICOSAPENT ETHYL

Submission received for:

March 2024 PBAC meeting

Opportunity for consumer comment:

Open 22/11/2023 and close 31/01/2024 (see PBS Website)

PBAC meeting:

Held on 13/03/2024

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

07/06/2024

Lodgement of required documentation:

16/06/2024

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 31/07/2024

Status:

Finalised

Government processes:

Commenced on 07/08/2024

Medicine listed on the PBS:

01/10/2024 (see PBS schedule)

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