Published: 10 March 2026
Committees
Agenda for the 76th meeting of the Medicines Classification Committee to be held on 22 April 2026
- Welcome
- Apologies
- Confirmation of the minutes of the 75th meeting held on 19 November 2025
- Declaration of conflicts of interest
- Matters arising
- Submissions for reclassification
- New medicines for classification
- Harmonisation of the New Zealand and Australian schedules
- Agenda items for the next meeting
- General business
- Date of the next meeting
1. Welcome
2. Apologies
3. Confirmation of the minutes of the 75th meeting held on 19 November 2025
4. Declaration of conflicts of interest
5. MATTERS ARISING
5.1. Objections to recommendations made at the 75th meeting
There were no objections to the recommendations made at the 75th meeting of the Medicines Classification Committee.
6. Submissions for reclassification
Medsafe notes that no public submissions were received for this meeting, or the 75th MCC meeting held in November 2025.
Both Medsafe and the MCC encourages interested stakeholders to make submissions on agenda items. The MCC process is an essential tool in enabling patient access to medicines where it is appropriate that they self-select them.
7. New medicines for classification
7.1 Capivasertib
Capivasertib is indicated in combination with fulvestrant for the treatment of adult patients with hormone receptor positive, human epidermal growth factor receptor 2 negative locally advanced or metastatic breast cancer following recurrence or progression on or after an endocrine based regimen.
7.2 Pretomanid
Pretomanid is indicated in combination with bedaquiline and linezolid for the treatment of adults with pulmonary tuberculosis due to Mycobacterium tuberculosis resistant to all of isoniazid, rifampicin, a fluoroquinolone and a second line injectable antibacterial medicine, and adults with pulmonary tuberculosis due to M. tuberculosis resistant to both isoniazid and rifampicin, who are treatment-intolerant or nonresponsive to standard therapy.
7.3 Amylin analogues
Amylin analogues are a class of synthetic substances that mimic the natural hormone amylin, a pancreatic peptide hormone involved in glycaemic regulation. Amylin analogues such as cagrilintide, pramlintide, and eloralintide are being developed for the treatment of obesity and type 1 and 2 diabetes. As further amylin analogues will likely be developed over time, Medsafe proposes a group entry for amylin analogues, as well as listing individual compounds as they arise.
- Cagrilintide is being developed for the treatment of obesity and type 2 diabetes.
- Pramlintide is used as an adjunct to mealtime insulin therapy for adults with type 1 and type 2 diabetes.
- Eloralintide is being developed for the treatment of obesity and type 2 diabetes.
8. Harmonisation of the New Zealand and Australian schedules
Recent scheduling changes made to the Poisons Standard in Australia are to be considered by the Medicines Classification Committee for their implementation in New Zealand.
Public consultation is an important part of the Medicines Classification Committee process, stakeholders are welcome to provide comments on all agenda items including those being considered for harmonisation.
The Medsafe Medicines Classification Committee - Public Consultation on Agenda Items webpage provides information on how to comment on agenda items. There are no harmonisation matters to be discussed at the 75th Medicines Classification Committee meeting.
8.1 New chemical entities which are not yet classified in New Zealand
4 September 2023 Scheduling Final Decisions Public Notice
8.1a Concizumab
Concizumab is an anti-tissue factor pathway inhibitor monoclonal antibody used in the treatment of haemophilia A and B.
From 1 October 2023 concizumab was classified as a Schedule 4 (prescription) medicine in Australia.
8.1b Givosiran
Givosiran is a small interfering RNA (siRNA) indicated for the treatment of acute hepatic porphyria in patients aged 12 years and over.
From 1 October 2023 givosiran was classified as a Schedule 4 (prescription) medicine in Australia.
8.1c Imlifidase
Imlifidase is indicated for the desensitisation treatment of highly sensitised adult kidney transplant candidates prior to kidney transplantation from a donor whom there is a positive cross-match.
From 1 October 2023 imlifidase was classified as a Schedule 4 (prescription) medicine in Australia.
8.1d Mirikizumab
Mirikizumab is a humanised immunoglobulin G4 monoclonal antibody that inhibits interaction of interkeukin (IL)-23 with its receptor. It is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response with, lost response to, or were intolerant to conventional therapy or a biological medicine, or have medical contraindications to such therapies.
From 1 October 2023 mirikizumab was classified as a Schedule 4 (prescription) medicine in Australia.
8.1e Olipudase alfa
Olipudase alfa is a recombinant human acid sphingomyelinase that is indicated as an enzyme replacement therapy for the treatment of non-central nervous system manifestations of acid sphingomyelinase deficiency in paediatric and adult patients with type A/B or type B.
From 1 October 2023 olipudase alfa was classified as a Schedule 4 (prescription) medicine in Australia.
8.1f Selpercatinib
Selpercatinib is indicated for the treatment of adult patients with locally advanced or metastatic RET fusion positive non-small cell lung cancer, and for the treatment of adult or adolescent patients with advanced or metastatic RET-mutant medullary thyroid cancer.
From 1 October 2023 selpercatinib was classified as a Schedule 4 (prescription) medicine in Australia.
8.1g Spesolimab
Spesolimab is a humanised antagonistic monoclonal immunoglobulin G1 antibody that blocks human IL-36 receptor signalling. It is indicated for the treatment of flares in adult patient with generalised pustular psoriasis.
From 1 October 2023 spesolimab was classified as a Schedule 4 (prescription) medicine in Australia.
8.1h Tafasitamab
Tafasitamab is a fragment crystallisable-enhanced monoclonal antibody that targets the CD19 antigen expressed on the surface of pre-B and mature B lymphocytes. It is indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who are not eligible for autologous stem cell transplant.
From 1 October 2023 tafasitamab was classified as a Schedule 4 (prescription) medicine in Australia.
8.1i Tagraxofusp
Tagraxofusp is an anti-cancer medication indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm.
From 1 October 2023 tagraxofusp was classified as a Schedule 4 (prescription) medicine in Australia.
8.1j Teclistamab
Teclistamab is a bispecific antibody that targets the CD3 receptor expressed on the surface of T-cells and B-cell maturation antigen. It is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
From 1 October 2023 teclistamab was classified as a Schedule 4 (prescription) medicine in Australia.
8.1k Tirbanibulin
Tirbanibulin binds to tubulin, disrupting microtubules and inducing cell cycle arrest and apoptosis. It is indicated for the topical field treatment of non-hyperkeratotic, nonhypertrophic actinic keratosis of the face or scalp in adults.
From 1 October 2023 tirbanibulin was classified as a Schedule 4 (prescription) medicine in Australia.
8.1l Vadadustat
Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor used in the treatment of symptomatic anaemia associated with chronic kidney disease in patients on chronic maintenance dialysis.
From 1 October 2023 vadadustat was classified as a Schedule 4 (prescription) medicine in Australia.
1 October 2025 Scheduling Final Decisions Public Notice
8.1m Seladelpar
Seladelpar is a peroxisome proliferator-activated receptor delta agonist used to treat primary biliary cholangitis in adults.
From 1 October 2025 seladelpar was classified as a Schedule 4 (prescription) medicine in Australia.
8.1n Sebetralstat
Sebetralstat is a plasma kallikrein inhibitor used to treat symptoms of hereditary angioedema in patients aged 12 years and older who have hereditary angioedema caused by a deficiency in the C1 inhibitor.
From 1 October 2025 sebetralstat was classified as a Schedule 4 (prescription) medicine in Australia.
8.1o Leniolisib
Leniolisib is a selective kinase inhibitor used to treat activated phosphoinositide 3-kinase delta syndrome in children.
From 1 October 2025 leniolisib was classified as a Schedule 4 (prescription) medicine in Australia.
8.1p Elinzanetant
Elinzanetant is a dual neurokinin 1 and 3 receptor antagonist used for the treatment of moderate to severe vasomotor symptoms associated with menopause.
From 1 October 2025 elinzanetant was classified as a Schedule 4 (prescription) medicine in Australia.
8.1q Delgocitinib
Delgocitinib is a JAK inhibitor used for the treatment of moderate to severe chronic hand eczema in adults for whom topical corticosteroids are inadequate or inappropriate.
From 1 October 2025 delgocitinib was classified as a Schedule 4 (prescription) medicine in Australia.
8.1r Cefiderocol
Cefiderocol is an antibiotic used for the treatment of infections caused by aerobic Gram-negative organisms in adults with limited treatment options.
From 1 October 2025 cefiderocol was classified as a Schedule 4 (prescription) medicine in Australia.
8.1s Bibrocathol
Bibrocathol is an antiseptic medication used to treat eyelid inflammation and eye infections.
From 1 October 2025 bibrocathol was classified as a Schedule 4 (prescription) medicine in Australia.
19 January 2026 Scheduling Final Decisions Public Notice
8.1t Imlunestrant
Imlunestrant is an oestrogen receptor antagonist indicated for the treatment of adults with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ER-1 mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
From 1 February 2026 imlunestrant was classified as a Schedule 4 (prescription) medicine in Australia.
8.1u Loncastuximab tesirine
Loncastuximab tesirine is a CD19-directed antibody indicated for the treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.
From 1 February 2026 loncastuximab tesirine was classified as a Schedule 4 (prescription) medicine in Australia.
8.1v Sodium thiosulfate
Sodium thiosulfate is indicated to reduce the risk of ototoxicity associated with cisplatin in paediatric patients 1 months or older with localised, non-metastatic solid tumours.
From 1 February 2026 sodium thiosulfate anhydrous was classified as a Schedule 4 (prescription) medicine in Australia.
8.1w Tofersen
Tofersen is a therapeutic oligonucleotide indicated for the treatment of amyotrophic lateral sclerosis in adults who have a mutation in the superoxide dismutase 1 gene.
From 1 February 2026 tofersen was classified as a Schedule 4 (prescription) medicine in Australia.
8.2 Decisions by the Secretary to Department of Health and Aged Care Australia (or the Secretary's Delegate)
8.2a Celecoxib
Celecoxib is a non-steroidal anti-inflammatory drug used to treat pain. On 1 February 2024, the Therapeutic Goods Administration (TGA) in Australia reclassified celecoxib for the treatment of acute pain due to primary dysmenorrhea or musculoskeletal or soft tissue injuries:
Schedule 4 (prescription); except when included in Schedule 3.
Schedule 3 (restricted); in tablets or capsules of 200 mg or less, in a primary pack not containing more than 10 dosage units for the short-term treatment of acute pain due to primary dysmenorrhea or musculoskeletal or soft tissue injuries in adults.
In New Zealand, celecoxib is currently a prescription only medicine.
At the 76th meeting, the MCC will consider whether it would be appropriate to reclassify celecoxib in New Zealand to harmonise with that in Australia.
8.2b Fluticasone
Fluticasone is a glucocorticoid used to treat asthma, inflammatory pruritic dermatoses, and allergic rhinitis. The TGA in Australia recently reclassified fluticasone propionate to amend the Schedule 2 (pharmacy-only) entry to include rhino-conjunctivitis as a permitted indication. A comparison of the Australian and New Zealand classification statements for fluticasone is shown below.
| Classification | Australia | New Zealand |
|---|---|---|
| Prescription (Schedule 4) | Except when included in Schedule 2 | Except when specified elsewhere in this schedule |
| Pharmacy-only (Schedule 2) | In aqueous nasal sprays delivering 50 micrograms or less of fluticasone per actuation when the maximum recommended daily dose is no greater than 400 micrograms, for the prophylaxis of allergic rhinitis or treatment of allergic rhinitis and rhino-conjunctivitis for up to 6 months in adults and children 12 years of age and over | For the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age when in aqueous nasal sprays delivering up to 50 micrograms per actuation with a maximum recommended daily dose of 200 micrograms (as a single dose) |
There are three key differences in how fluticasone is classified in Australia compared with New Zealand: Australia allows a higher maximum recommended daily dose (400 micrograms versus 200 micrograms in New Zealand), includes rhino-conjunctivitis as an approved indication, and specifies a treatment duration limit of up to six months.
In New Zealand, Medsafe has previously considered products containing fluticasone for rhino-conjunctivitis to fall within the pharmacy-only classification.
At its 33rd meeting in 2005, the MCC considered aligning the maximum recommended daily dose with Australia, but recommended against harmonisation at that time.
At the 76th meeting, the MCC will consider whether it would be appropriate to harmonise the classification of fluticasone in New Zealand to that in Australia. The maximum recommended daily dose, approved indications, and treatment duration will be considered.
8.2c Intravenous potassium salts
Following a period of public consultation, on 19 January 2026 the TGA published their final decision regarding the classification of intravenous potassium salts.
Intravenous potassium is used for the prevention and treatment of moderate to severe potassium deficiency (hypokalaemia) when oral therapy is not possible or rapid replacement is necessary. Injection of undiluted solution or infusion without controlled rate of delivery, such as in rapid administration, can cause cardiac arrest or death.
Due to the risk of harm from unscheduled potassium salts, from 1 February 2027 the TGA will introduce a new Schedule 4 (prescription) entry for intravenous potassium salts as follows:
| Schedule 4 (prescription) |
Potassium salts, including chloride, phosphate or acetate salts of potassium alone or in any combination, in preparations for therapeutic use for injection or infusion except:
- in preparations with a concentration of less than 10 mmol/100 mL of potassium; or - in preparations in pre-mixed infusion bags |
As explained in the TGA final decision notice, this decision aimed to balance the benefits of increased prescriber oversight against the unintended possibility of decreasing access to potassium for legitimate clinical purposes, as well as logistical challenges associated with the change. As such, the prescription entry excludes IV potassium in pre-mixed bags for infusion to maintain rapid access in emergency care settings, and to avoid logistical challenges of storing these bulky preparations.
The Australian classification is therefore designed to capture ampoule preparations containing 10 mmol/100 mL or greater.
Should New Zealand implement a similar classification entry for intravenous potassium salts, Medsafe estimates that seven approved products would be affected.
At the 76th meeting, the MCC will consider whether it would be appropriate to introduce a similar classification entry for intravenous potassium salts.
As parenteral nutrition preparations are exempt from scheduling in Australia under Appendix A of the Poisons Standard, such products are automatically excluded. This is not the case in New Zealand. As such, the MCC will consider the following classification statement for potassium salts in New Zealand:
Prescription; including chloride, phosphate or acetate salts of potassium alone or in any combination, in preparations for therapeutic use for injection or infusion except in preparations with a concentration of less than 10 mmol/100 mL of potassium; except in preparations in pre-mixed infusion bags; except in parenteral nutrition replacement preparations
8.2d Intranasal adrenaline
On 22 January 2026, the TGA published their final decision regarding the classification of intranasal adrenaline.
Intranasal adrenaline is used as a needle-free alternative to auto-injector adrenaline pens for the treatment of anaphylaxis. Australia have reclassified adrenaline to introduce a Schedule 3 (restricted) entry for intranasal adrenaline preparations:
Schedule 4 (prescription); in topical preparations for the treatment of wounds in humans; all other preparations containing adrenaline except when included in or expressly excluded from Schedule 3.
Schedule 3 (restricted); in preparations containing 1% or less of adrenaline; intranasal preparations containing 2% or less of adrenaline; except in preparations that are not for injection containing 0.02% or less of adrenaline
There are currently no intranasal adrenaline products approved in New Zealand. Medsafe has received one new medicine application for an intranasal adrenaline product, which is currently under assessment. The classification of adrenaline in New Zealand is as follows:
| Prescription | in medicines containing more than 1% |
| Restricted | in medicines containing 1% or less except in medicines for injection containing 0.02% or less; except in medicines for injection containing 0.1% for use in practice in an emergency by a dental therapist, an oral health therapist or a dental hygienist registered with the Dental Council |
| General sale | in medicines for injection containing 0.02% or less |
At the 76th meeting, the MCC will consider whether it would be appropriate to introduce a restricted entry for intranasal adrenaline preparations.
9. Agenda items for the next meeting
10. General business
11. Date of the next meeting
