ADALIMUMAB

Brand name:

• Ardalicip®
• Adalicip®

Form and strength:

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

Submission sponsor:

CIPLA AUSTRALIA PTY LTD

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 (–)

Comment:

--

Other PBAC consideration:

--

Submission received for:

July 2023 PBAC meeting

Opportunity for consumer comment:

Open 29/03/2023 and close 24/05/2023 (see PBS Website)

PBAC meeting:

Held on 05/07/2023

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

31/07/2023

Lodgement of required documentation:

09/08/2023

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 15/08/2023

Status:

Finalised

Government processes:

Commenced on 22/08/2023

Medicine listed on the PBS:

01/01/2024 (see PBS schedule)