ADALIMUMAB

Brand name:

• Hadlima®

Form and strength:

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

Condition/indication:
(therapeutic use)

• Severe Crohn disease Moderate to severe ulcerative colitis Severe active juvenile idiopathic arthritis Complex refractory fistulising Crohn disease Severe active rheumatoid arthritis Severe psoriatic arthritis Ankylosing spondylitis Severe chronic plaque psoriasis Moderate to severe hidradenitis suppurativa

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 (Category 4)

Comment:

--

Submission sponsor:

Organon Pharma Pty Ltd

Other PBAC consideration:

--

Submission received for:

November 2023 PBAC meeting

Opportunity for consumer comment:

Open 26/07/2023 and close 20/09/2023 (see PBS Website)

PBAC meeting:

Held on 01/11/2023

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

07/03/2024

Lodgement of required documentation:

28/03/2024

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 02/07/2024

Status:

Finalised

Government processes:

Commenced on 15/07/2024

Medicine listed on the PBS:

01/10/2024 (see PBS schedule)

---