GOSERELIN

Information current as at: 1 November 2026

Legend: Completed N In progress Not applicable N Yet to commence

Submission Details

Brand name:
  • Zoladex®
Form and strength:
  • Subcutaneous implant (long acting) 10.8 mg (as acetate) in pre-filled injection syringe
Submission sponsor:
ASTRAZENECA PTY LTD
Condition/indication:
(therapeutic use)
  • HR+ Breast Cancer
Listing requested:
To consider a request for the listing of goserelin subcutaneous implant (long acting) 10.8 mg (as acetate) in pre-filled injection syringe for the treatment of hormone receptor positive (HR+) breast cancer.
Funding program:
PBS General Schedule
Request authority level:
Restricted Benefit
PBAC Submission type:
Change to existing listing (Category 2)
Comment:
--
Other PBAC consideration:
--

Progress Details

Submission received for:
September 2026 PBAC meeting
Opportunity for consumer comment:
Open 28/08/2026 and close 02/09/2026 (see PBS Website)
PBAC meeting:
Held on 04/09/2026
PBAC outcome published:
Recommended (see PBAC Outcomes)
Notice of intent submitted:
28/09/2026
Lodgement of required documentation:
08/10/2026
Acceptance of complete documentation:
Accepted
Agreement to listing arrangements:
Commenced on 14/10/2026
Status:
Finalised
7Government processes:
Commenced on 14/10/2026
8Medicine listed on the PBS:
Has not yet occurred

PBAC Outcome

PBAC Recommendation:

The PBAC recommended that the General Benefit listing for goserelin 10.8 mg subcutaneous implant be made unrestricted. The PBAC noted that the submission requested a breast cancer indication be added to the existing PBS listing for goserelin 10.8 mg implant. However, the sponsor had made a further request for an unrestricted listing. The PBAC considered that, among matters, an unrestricted listing for goserelin 10.8 mg would be acceptable at the current AEMP. The PBAC noted and welcomed input from individuals, health professionals and professional organisations. The PBAC acknowledged the importance of having a range of GnRH medicines available on the PBS and supporting patient preferences. The PBAC advised that an unrestricted listing would align with contemporary and evidence-based clinical practice. 

Public Summary Document:
Not yet available

Case ID
a1318
Page last updated
31 October 2026
v.9.20