OFATUMUMAB

Brand name:

• Kesimpta®

Pharmaceutical company:

Novartis Pharmaceuticals Australia Pty Ltd

Condition/indication:
(therapeutic use)

• Multiple sclerosis (MS)

PBAC Submission type:

New listing (Major Submission)

Comment:

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Public Summary Document:

PBAC Public Summary Documents – March 2021

Related medicines:

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Submission received for:

March 2021 PBAC meeting

Opportunity for consumer comment:

Open 23/12/2020 and close 10/02/2021 (see PBS Website)

PBAC meeting:

Held on 10/03/2021

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

06/04/2021

Lodgement of required documentation:

28/04/2021

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 06/05/2021

Status:

Finalised

Government processes:

Commenced on 07/06/2021

Medicine listed on the PBS:

01/10/2021 (see PBS schedule)

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