TACROLIMUS
Information current as at: 1 July 2026
Submission Details
- Brand name:
-
- aZematop®
- Form and strength:
- Please search for and view the medicine's Public Summary Document (PSD) for more information
- Submission sponsor:
- ARROTEX PHARMACEUTICALS PTY LTD
- Condition/indication:
(therapeutic use) -
- Atopic dermatitis
- Listing requested:
- Please see PSD for more information
- Funding program:
- PBS General Schedule
- Request authority level:
- Please see PSD for more information
- PBAC Submission type:
- New PBS listing (Matters arising/Matters outstanding)
- Comment:
- --
- Other PBAC consideration:
Progress Details
-
Submission received for: - March 2026 PBAC meeting
-
Opportunity for consumer comment: - Open 02/04/2025 and close 28/05/2025 (see PBS Website)
-
PBAC meeting: - Held on 11/03/2026
-
Lodgement of required documentation: - 13/05/2026
-
Acceptance of complete documentation:
- Accepted
-
6Agreement to listing arrangements:
- Commenced on 26/05/2026
-
Status:
- Under consideration
-
7Government processes:
- Has not yet commenced
-
8Medicine listed on the PBS:
- Has not yet occurred
PBAC Outcome
The PBAC recommended the listing of 0.1% tacrolimus ointment for the treatment of flare-ups in to moderate to severe atopic dermatitis (AD) affecting the body, face and eyelids in patients whose condition is not adequately controlled with topical corticosteroids. The PBAC recalled that it had previously recommended 0.1% tacrolimus for a broader population as an alternative to topical corticosteroids. The PBAC considered that the proposed restriction, with some changes, would better limit use of 0.1% tacrolimus for flares to use after treatment with topical corticosteroids. The PBAC advised that the cost of 0.1% tacrolimus would be acceptable if the overall cost was similar to 1% pimecrolimus. The PBAC considered that 0.1% tacrolimus may be used in patients who may not have trialled topical corticosteroids first and recommended a risk sharing arrangement (RSA) to manage this risk.