Published: 10 June 2025

Committees

Agenda for the 74th meeting of the Medicines Classification Committee to be held on 23 July 2025

  1. Welcome
  2. Apologies
  3. Confirmation of the minutes of the 73rd meeting held on 26 February 2025.
  4. Declaration of conflicts of interest
  5. Submissions for reclassification
  6. New medicines for classification
  7. Harmonisation of the New Zealand and Australian schedules
  8. Matters arising
  9. Agenda items for the next meeting
  10. General business
  11. Date of the next meeting

1. Welcome

2. Apologies

3. Confirmation of the minutes of the 73rd meeting held on 26 February 2025

4. Declaration of conflicts of interest

5. Submissions for reclassification

5.1. Tenofovir disoproxil and emtricitabine (Burnett Foundation)

Tenofovir disoproxil and emtricitabine are used for the treatment of HIV, and in pre-exposure prophylaxis (with other safe sex practices) to reduce the risk of sexually acquired HIV.

Tenofovir disoproxil and emtricitabine were recently discussed at the 73rd MCC meeting held on 26 February 2025. The original submission (PDF, 11.91MB, 324 pages) proposed that tenofovir disoproxil and emtricitabine be reclassified to:

Prescription: except when supplied for HIV prophylaxis to people who are over 18, are HIV negative, and meet the clinical and eligibility criteria of an approved training programme, when provided by a pharmacist who meets the requirements of the Pharmacy Council.

At that time, the MCC recommended to defer a decision on tenofovir disoproxil and emtricitabine, pending further information from the submitter. This resubmission (PDF, 1.11MB, 26 pages) will be considered at the 74th MCC meeting.

5.2. Respiratory Syncytial Virus (RSV) vaccine, adjuvanted (GSK New Zealand)

This submission (PDF, 928KB, 26 pages) is a proposal for the classification of the Respiratory Syncytial Virus (RSV) vaccine to be expanded to include persons aged 50-59 who are at increased risk of RSV disease. The proposed reclassification is:

Prescription: except when administered for the prevention of lower respiratory tract disease caused by respiratory syncytial virus RSV-A and RSV-B subtypes to a person 60 years of age and older, or persons 50 through 59 years of age who are at increased risk for RSV disease, by registered pharmacists and/or authorised vaccinator, who have successfully completed the Vaccinator Foundation Course (or any equivalent training course approved by Te Whatu Ora) and who complies with the immunisation standards of Health NZ/Te Whatu Ora.

The classification of the RSV vaccine was recently considered at the 72nd MCC meeting held on 12 June 2024, where expansion to enable administration of the vaccine by specified vaccinators, without prescription, to those 60 years of age and over, was proposed. At that time, the MCC recommended not to reclassify the RSV vaccine based on the information submitted.

However, as discussed at the 73rd MCC meeting, following the receipt of additional information provided by the submitters, the Group Manager of Medsafe, Ministry of Health, acting under delegated authority, changed the classification of the RSV vaccine by gazette on 18 December 2024.

The current submission seeks to further expand administration of the vaccine by specified vaccinators, without a prescription, to those aged 50 years and older. This follows approval of an extension to the approved indication to include this age group.

5.3. Bilastine (Menarini New Zealand Pty Limited)

Bilastine is a non-sedating antihistamine used for the symptomatic treatment of seasonal and perennial allergic-rhinoconjunctivitis and urticaria. The current classification of bilastine in New Zealand is:

Prescription: except when specified elsewhere in this schedule

Pharmacy-only: for oral use

This submission (PDF, 211KB, 15 pages) proposes to change the classification of bilastine to:

Prescription: except when specified elsewhere in this schedule

Pharmacy-only: for oral use; for ophthalmic use in adults except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board.

5.4. Lithium (Prof Julia Rucklidge)

This submission (PDF, 219KB, 16 pages) proposes changes to the classification of lithium to introduce a recommended daily dose of 3 mg:

Prescription: except when specified elsewhere in this schedule

Pharmacy-only: for dermal use in medicines containing 1% or less but more than 0.01%; except when present as an excipient in dermal medicines containing 0.25% or less; except when present in products for internal use containing no more than 3 mg of lithium as the recommended daily dose

General sale: for dermal use in medicines containing 0.01% or less; when present as an excipient in medicines for dermal use containing 0.25% or less; when present in products for internal use containing no more than 3 mg of lithium as the recommended daily dose

5.5. Vitamin D (Prof Julia Rucklidge)

This submission (PDF, 221KB, 15 pages) proposes changes to the classification of Vitamin D (including cholecalciferol and ergocalciferol) to increase the recommended daily dose limit from 25 micrograms to 75 micrograms:

Prescription: for internal use in medicines containing more than 75 micrograms per recommended daily dose except in parenteral nutrition replacement preparations

General sale: when in products for internal use containing 75 micrograms or less per recommended daily dose; when in parenteral nutrition replacement preparations; when in products for external use

5.6. Paracetamol – proposal to allow provision by vaccinators (Te Whatu Ora, Health NZ)

This submission  (PDF, 109KB, 2 pages) proposes to amend the classification of paracetamol to include a statement that permits authorised vaccinators to administer liquid paracetamol to children under the age of 2 years concurrently with the Bexsero vaccine to prevent and treat fever:

Pharmacy-only; except when administered by vaccinators, registered pharmacists, or registered intern pharmacists who have successfully completed the Vaccinator Foundation Course (or any equivalent training course approved by the Ministry of Health) and who comply with the immunisation standards of the Immunisation Handbook, to a child under the age of two with the administration of Bexsero vaccine to prevent and treat fever.

5.7. Peptide Groups (Medsafe)

This submission (PDF, 509KB, 16 pages) from Medsafe proposes to introduce ten group entries for unscheduled peptides that have been intercepted at the border, to classify them as prescription medicines. Many of these peptides are being sold to private individuals who intend to administer them for a therapeutic purpose, posing a risk to health as the product quality, efficacy, and interactions with other medicines are unknown. The proposed group entries are:

  • Thymic peptide hormones and their analogues
  • Body Protective Compound (BPC)-157 and its analogues
  • Adrenocorticotropic hormone analogues
  • Pineal gland peptides and their analogues
  • Anti-microbial peptides and their precursors
  • Myostatin modulator peptides
  • Mitochondria-derived peptides and their analogues
  • Erythropoietin and its analogues
  • Tuftsin and its analogues
  • Kisspeptins

This submission also proposes the classification of six individual peptides as prescription medicines: larazotide, PTD-DBM, AICAR, B7-33, PNC-27, and SS-31.

6. New medicines for classification

The following new chemical entities are submitted to the Committee for classification.

New chemical entities

6.1 Anifrolumab

Anifrolumab is a human immunoglobulin G1 kappa (IgG1k) monoclonal antibody indicated in adult patients with moderate to severe active systemic lupus erythematosus (SLE), despite standard therapy.

6.2 Deutivacaftor

Deutivacaftor is a cystic fibrosis transmembrane conductance regulator (CFTCR) potentiator included in a triple combination therapy (vanzacaftor/tezacaftor/deutivacaftor) indicated for the treatment of cystic fibrosis in people aged 6 years and older who have at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator gene.

6.3 Mirvetuximab soravtansine

Mirvetuximab soravtansine is a folate receptor alpha (FRa)-directed antibody-drug conjugate indicated in the treatment of adult patients with FRa-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.

6.4 Vanzacaftor

Vanzacaftor is a cystic fibrosis transmembrane conductance regulator (CFTCR) modulator included in a triple combination therapy (vanzacaftor/tezacaftor/deutivacaftor) indicated for the treatment of cystic fibrosis in people aged 6 years and older who have at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator gene.

7. 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.

7.1 New chemical entities which are not yet classified in New Zealand

27 September 2024 Scheduling Final Decisions Public Notice

7.1a Vutrisiran

Vutrisiran is a medicine indicated in the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.

From 1 October 2024 vutrisiran was classified as a Schedule 4 (prescription) medicine in Australia.

7.1b Ritlecitinib

Ritlecitinib is a Janus-associated kinase (JAK) inhibitor indicated in the treatment of severe alopecia areata in adults and adolescents 12 years of age and older.

From 1 October 2024 ritlecitinib was classified as a Schedule 4 (prescription) medicine in Australia.

7.1c Odevixibat

Odevixibat is a selective inhibitor of the ileal bile acid transporter (IBAT) indicated in the treatment of progressive familial intrahepatic cholestasis.

From 1 October 2024 odevixibat was classified as a Schedule 4 (prescription) medicine in Australia.

7.1d Pinaverium bromide

Pinaverium bromide is a calcium channel blocker indicated in the treatment of functional gastrointestinal disorders, including irritable bowel syndrome (IBS).

From 1 October 2024 pinaverium bromide was classified as a Schedule 4 (prescription) medicine in Australia.

7.1e Lumasiran

Lumasiran is a medicine indicated in the treatment of primary hyperoxaluria type 1 (PH1) in all age groups.

From 1 October 2024 lumasiran was classified as a Schedule 4 (prescription) medicine in Australia.

7.1f Capivasertib

Capivasertib is an anti-cancer drug (used in combination with fulvestrant) that is indicated in the treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer, following recurrence or progression on or after an endocrine-based regimen.

From 1 October 2024 capivasertib was classified as a Schedule 4 (prescription) medicine in Australia.

7.1g Vorasidenib

Vorasidenib is an inhibitor of mutated isocitrate dehydrogenase (IDH) 1 and 2 enzymes. It is indicated in the treatment of Grade 2 astrocytoma or oligodendroglioma brain tumours with a susceptible IDH1 or IDH2 mutation in adults and children aged 12 years and older, who do not require immediate chemotherapy or radiotherapy following surgical intervention.

From 1 October 2024 vorasidenib was classified as a Schedule 4 (prescription) medicine in Australia.

7.1h Iptacopan

Iptacopan is a complement system inhibitor indicated in the treatment of adults with paroxysmal nocturnal haemoglobinuria.

From 1 October 2024 iptacopan was classified as a Schedule 4 (prescription) medicine in Australia.

7.1i Danicopan

Danicopan is a complement system inhibitor indicated in the treatment of adults with paroxysmal nocturnal haemoglobinuria.

From 1 October 2024 danicopan was classified as a Schedule 4 (prescription) medicine in Australia.

7.1j Sotatercept

Sotatercept is an activin signalling inhibitor indicated in the treatment of pulmonary arterial hypertension.

From 1 October 2024 sotatercept was classified as a Schedule 4 (prescription) medicine in Australia.

16 December 2024 Scheduling Final Decisions Public Notice

7.1k Fedratinib

Fedratinib is an anti-cancer medication indicated in the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombycythaemia who are Janus-associated kinase (JAK) naïve or have been treated with ruxolitinib.

From 1 February 2025 fedratinib was classified as a Schedule 4 (prescription) medicine in Australia.

7.1l Abaloparatide

Abaloparatide is a medicine indicated in the treatment of osteoporosis in post-menopausal women at increased risk of fracture.

From 1 February 2025 abaloparatide was classified as a Schedule 4 (prescription) medicine in Australia.

7.1m Efgartigimod alfa

Efgartigimod alfa is a medicine indicated as an add-on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.

From 1 February 2025 efgartigimod alfa was classified as a Schedule 4 (prescription) medicine in Australia.

7.1n Dexrazoxane

Dexrazoxane is a medicine indicated for use in the prevention of cardiotoxicity caused by anthracycline use.

From 1 February 2025 dexrazoxane was classified as a Schedule 4 (prescription) medicine in Australia.

7.1o Zolbetuximab

Zolbetuzimab is a monoclonal antibody indicated for patients with human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours are Claudin (CLDN) 18.2 positive.

From 1 February 2025 zolbetuximab was classified as a Schedule 4 (prescription) medicine in Australia.

7.1p Marstacimab

Marstacimab is a monoclonal antibody indicated for routine prophylaxis of bleeding episodes in patients 12 years of age and older with either severe haemophilia A without factor VIII inhibitors or severe haemophilia B without factor IX inhibitors.

From 1 February 2025 marstacimab was classified as a Schedule 4 (prescription) medicine in Australia.

7.1q Rozanolixizumab

Rozanolixizumab is a monoclonal antibody indicated as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

From 1 February 2025 rozanolixizumab was classified as a Schedule 4 (prescription) medicine in Australia.

7.1r Elacestrant dihydrochloride

Elacestrant dihydrochloride is a selective oestrogen receptor degrader indicated in the treatment of oestrogen receptor (ER) positive and human epidermal growth factor receptor 2 (HER2) negative, oestrogen receptor (ESR) 1 mutated, advanced or metastatic breast cancer.

From 1 February 2025 elacestrant dihydrochloride was classified as a Schedule 4 (prescription) medicine in Australia.

7.1s Cipaglucosidase alfa

Cipaglucosidase alfa is a long-term enzyme replacement therapy used in combination with the enzyme stabilise miglustat for the treatment of adults with late onset Pompe disease (acid alpha-glucosidase deficiency).

From 1 February 2025 cipaglucosidase alfa was classified as a Schedule 4 (prescription) medicine in Australia.

7.1t Inebilizumab

Inebilizumab is a monoclonal antibody indicated in the treatment of adult patients with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive.

From 1 February 2025 cipaglucosidase alfa was classified as a Schedule 4 (prescription) medicine in Australia.

7.1u Palopegteriparatide

Palopegteriparatide is a parathyroid hormone (PTH) analogue indicated for the replacement of endogenous PTH in adult patients with hypoparathyroidism.

From 1 February 2025 palopegteriparatide was classified as a Schedule 4 (prescription) medicine in Australia.

7.1v Garadacimab

Garadacimab is a monoclonal antibody against the activated coagulation factor XIIa. It is indicated for routine prevention of recurrent hereditary angioedema (HAE) attacks in patients aged 12 years and older with C1-esterase inhibitor deficiency/dysfunction HAE.

From 1 February 2025 garadacimab was classified as a Schedule 4 (prescription) medicine in Australia.

7.1w Sodium citrate dihydrate

Sodium citrate dihydrate is a biological buffer and anticoagulant for therapeutic use in dialysis, diafiltration, or total plasma exchange.

From 1 February 2025 sodium citrate dihydrate was classified as a Schedule 4 (prescription) medicine in Australia.

19 May 2025 Scheduling Final Decisions Public Notice

7.1x Datopotamab deruxtecan

Datopotamab deruxtecan is an anti-cancer medication indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer who have received prior systemic therapy.

From 1 June 2025 datopotamab deruxtecan was classified as a Schedule 4 (prescription) medicine in Australia.

7.1y Elafibranor

Elafibranor is indicated for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as a monotherapy in adults unable to tolerate UDCA.

From 1 June 2025 elafibranor was classified as a Schedule 4 (prescription) medicine in Australia.

7.1z Futibatinib

Futibatinib is a kinase inhibitor used in the treatment of metastatic cholangiocarcinoma (bile duct cancer).

From 1 June 2025 futibatinib was classified as a Schedule 4 (prescription) medicine in Australia.

7.1aa Inavolisib

Inavolisib is an anti-cancer medication indicated for the treatment of adult patients with PIK3CA-mutateed, hormone receptor positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer.

From 1 June 2025 inavolisib was classified as a Schedule 4 (prescription) medicine in Australia.

7.1ab Landiolol

Landiolol is a beta-blocker used for the acute treatment of elevated heart rate and irregular heartbeat (arrhythmia).

From 1 June 2025 landiolol was classified as a Schedule 4 (prescription) medicine in Australia.

7.1ac Lazertinib

Lazertinib is a kinase inhibitor is a first-line treatment for adults with locally advanced or metastatic non-small cell lung cancer, in combination with amivantamab.

From 1 June 2025 lazertinib was classified as a Schedule 4 (prescription) medicine in Australia.

7.1ad Pegunigalsidase alfa

Pegunigalsidase alfa is a recombinant enzyme replacement therapy used in the treatment of Fabry disease, a genetic disorder causing a deficiency of the enzyme alpha-galactosidase A.

From 1 June 2025 pegunigalsidase alfa was classified as a Schedule 4 (prescription) medicine in Australia.

7.1ae Repotrectinib

Repotrectinib is an anti-cancer medication indicated for the treatment of adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer.

From 1 June 2025 repotrectinib was classified as a Schedule 4 (prescription) medicine in Australia.

7.1af Sepiapterin

Sepiapterin is an oral therapy for the treatment of individuals with hyperphenylalaninaemia.

From 1 June 2025 sepiapterin was classified as a Schedule 4 (prescription) medicine in Australia.

7.1ag Teprotumumab

Teprotumumab is a monoclonal antibody indicated for the treatment of Thyroid Eye Disease (Graves’ ophthalmopathy).

From 1 June 2025 teprotumumab was classified as a Schedule 4 (prescription) medicine in Australia.

7.1ah Velmanase alfa

Velmanase alfa is a recombinant human lysosomal alpha-mannosidase used to treat alpha-mannosidosis.

From 1 June 2025 velmanase alfa was classified as a Schedule 4 (prescription) medicine in Australia.

7.2 Decisions by the Secretary to Department of Health and Aged Care Australia (or the Secretary’s Delegate)

7.2a Desloratadine

Desloratadine is a second-generation antihistamine used to treat seasonal allergic rhinitis.

The TGA recently made the final decision to reschedule desloratadine to permit general sales supply. The new classification in Australia is:

Schedule 4 (Prescription)

except when included in Schedule 2; or in divided preparations for oral use for the treatment of seasonal allergic rhinitis in adults and children 6 years and over, when:

in a primary pack containing 10 dosage units or less; and

labelled with a recommended daily dose not exceeding 5 mg of desloratadine.

Schedule 2 (Pharmacy-only)

in preparations for oral use except in divided preparations for the treatment of seasonal allergic rhinitis when:

in a primary pack containing 10 dosage units or less when labelled for adults and children 6 years and over; and

labelled with a recommended daily dose not exceeding 5 mg of desloratadine.


This scheduling change was implemented on 1 February 2025.

In New Zealand, desloratadine is currently scheduled as:

Prescription; except for oral use

Pharmacy-only; for oral use

At the 74th meeting, the MCC will consider whether it would be appropriate to reclassify desloratadine in New Zealand to harmonise with Australia.

7.2b Atropa belladonna

Atropa belladonna (commonly known as deadly nightshade or belladonna) is a herbaceous plant used in some herbal/alternative medicines. 

The TGA recently made the final decision to reschedule Atropa belladonna to introduce an age limit for pharmacy-only supply to reduce toxicity in children. The new classification of Atropa belladonna in Australia is:

Schedule 4 (Prescription)

except when included in Schedule 2

 

Schedule 2 (Pharmacy-only)

for external use in preparations containing 0.03% or less of total solanaceous alkaloids; or

for oral use in adults and children 6 years of age and over:

in undivided preparations containing 0.03% or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or

in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit, when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids

This scheduling change was implemented on 1 June 2025.

The classification of Atropa belladonna in New Zealand is:

Prescription: except when specified elsewhere in this schedule; except in medicines containing 300 micrograms or less of total solanaceous alkaloids per litre or per kilogram

Pharmacy-only; for external use in medicines containing 0.03% or less of the alkaloids of belladonna; for oral use in liquid form in medicines containing 0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milligrams per recommended daily dose of the alkaloids of belladonna or in solid dose form in medicines containing 0.3 milligrams or less per dose form and not more than 1.2 milligrams per recommended daily dose of the alkaloids of belladonna

At the 74th meeting, the MCC will consider whether it would be appropriate to reclassify Atropa belladonna in New Zealand to introduce an age limit, as in Australia.

There are no products containing Atropa belladonna with current approval in New Zealand.

8. Matters arising

8.1 Objections to recommendations made at the 73rd meeting

The deadline for intentions to object to a recommendation made at the 73rd MCC meeting, together with a statement of the grounds on which the objection would be made, was 16 May 2025. No valid objections were received.

8.2 Brimonidine

Brimonidine is a medicine which may be used to lower intraocular pressure in patients under certain conditions, or may be used to relieve redness of the eye due to minor eye irritations. From 1 June 2023 the TGA re-scheduled brimonidine to:

  • Schedule 4 (prescription): except when included in schedule 2,
  • Schedule 2 (pharmacy-only): in ophthalmic preparations for adult use containing not more than 0.025% brimonidine.

In New Zealand brimonidine is currently classified as a prescription medicine.

Brimonidine was an agenda item at the 71st MCC meeting held on 14 November 2023. Two comments were received that supported the proposed alignment with Australia.

The MCC discussed the risks and benefits of reclassification, and noted that submissions from ophthalmologist and optometrist professional bodies would be beneficial. The MCC recommended that the classification of brimonidine should align with Australia, and therefore be amended to:

  • Prescription: except when specified elsewhere in this schedule.
  • Pharmacy-only: in ophthalmic preparations containing not more than 0.025% brimonidine.

Following the meeting, Medsafe invited several optometrist and ophthalmologist professional bodies to comment on this recommendation. Two valid objections were received, on the grounds that the MCC did not consider all safety information, as this was not provided to them:

  • Some topical decongestants have a history of inappropriate use and/or overuse.
  • The risk of allergic reaction and whether this risk would be reduced for products with strengths lower than 0.025% should be further investigated.

The Minister’s delegate therefore decided to refer brimonidine to a future MCC meeting for further consideration.

Medsafe encourages further comments on this item.

8.3 Sedating antihistamines

Sedating antihistamines were discussed at the 72nd MCC meeting held on 12 June 2024. The MCC decided to recommend reclassification of sedating antihistamines to remove the indication for sedation in children aged under 12 years, which was consistent with the Medsafe submission for reclassification. These changes were implemented on 17 April 2025 via gazette notice

The MCC also recommended that all oral sedating antihistamines available over-the-counter are restricted to use in those aged 6 years and older. There were two valid objections received regarding this recommendation to change the restricted classification for sedating antihistamines from children over 2 years of age, to children over 6 years of age. These objections have been accepted as valid on the basis that the MCC made recommendations of a broader scope than the submission provided to them.

To further consider the MCC recommendation, the Minister’s delegate decided to refer sedating antihistamines to a future MCC meeting to discuss the restricted classification age limit of sedating antihistamines.

8.4 Cetirizine

Cetirizine is a non-sedating antihistamine used to treat allergic rhinitis, dermatitis, and urticaria. On 20 January 2023, the Therapeutic Goods Administration (TGA) in Australia made the final decision to reschedule cetirizine to allow general sale supply for oral use for the treatment of seasonal allergic rhinitis in adults and children 6 years of age and over (previously 12 years of age and over) when in a primary pack containing not more than 10 days’ supply, and labelled with a recommended daily dose not exceeding 10 mg of cetirizine. This change was implemented on 1 February 2023.

In New Zealand, cetirizine at general sale is currently classified as:

General sale: in divided solid dosage forms for oral use containing 10 milligrams or less of cetirizine hydrochloride per dose form for the treatment of seasonal allergic rhinitis when sold in the manufacturer’s original pack containing not more than 5 days’ supply.

Harmonisation of the classification of cetirizine with Australia was discussed at the 71st MCC meeting held on 14 November 2023. At that time, the MCC noted that whilst further public consultation could be useful, they recommended to reclassify cetirizine in line with Australia.

The Minister’s delegate has referred this item back to the MCC for a recommendation on cetirizine, with a particular focus on the age limits for general sale supply.  

9. Agenda items for the next meeting

10. General business

11. Date of the next meeting

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