GALCANEZUMAB

Brand name:

• Emgality®

Form and strength:

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

Condition/indication:
(therapeutic use)

• Treatment-resistant chronic migraine

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 (Minor submission)

Comment:

The PBAC provided additional advice to the Minister (under section 101(3) of the National Health Act 1953 (“the Act”)), in relation to its recommendation made between 10 – 12 July 2019 for the drug galcanezumab.

Submission sponsor:

Eli Lilly Australia Pty Ltd

Other PBAC consideration:

• GALCANEZUMAB

Submission received for:

November 2020 PBAC meeting

Opportunity for consumer comment:

Open 26/08/2020 and close 07/10/2020 (see PBS Website)

PBAC meeting:

Held on 04/11/2020

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

22/02/2021

Lodgement of required documentation:

04/03/2021

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 12/03/2021

Status:

Finalised

Government processes:

Commenced on 12/03/2021

Medicine listed on the PBS:

01/06/2021 (see PBS schedule)

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