CEMIPLIMAB

Brand name:

• Libtayo®

Form and strength:

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

Submission sponsor:

sanofi-aventis Australia Pty Ltd

Condition/indication:
(therapeutic use)

• Squamous cell carcinoma

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 (–)

Comment:

--

Other PBAC consideration:

--

Submission received for:

March 2022 PBAC meeting

Opportunity for consumer comment:

Open 24/11/2021 and close 27/01/2022 (see PBS Website)

PBAC meeting:

Held on 09/03/2022

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

20/04/2022

Lodgement of required documentation:

02/06/2022

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 26/07/2022

Status:

Finalised

Government processes:

Commenced on 30/08/2022

Medicine listed on the PBS:

01/11/2022 (see PBS schedule)