OMALIZUMAB

Brand name:

• Omlyclo®

Pharmaceutical company:

CELLTRION HEALTHCARE AUSTRALIA PTY LTD

Condition/indication:
(therapeutic use)

• Uncontrolled severe asthma Uncontrolled severe allergic asthma Severe chronic spontaneous urticaria

PBAC Submission type:

New PBS listing (Category 3)

Comment:

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Public Summary Document:

PBAC Public Summary Documents – March 2025

Related medicines:

--

Submission received for:

March 2025 PBAC meeting

Opportunity for consumer comment:

Open 27/11/2024 and close 29/01/2025 (see PBS Website)

PBAC meeting:

Held on 12/03/2025

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

28/04/2025

Lodgement of required documentation:

15/05/2025

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 10/06/2025

Status:

Finalised

Government processes:

Commenced on 17/06/2025

Medicine listed on the PBS:

01/08/2025 (see PBS schedule)

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