Pursuant to section 106(1) of the Medicines Act 1981, I, Chris James, Group Manager, Medsafe, Ministry of Health, acting under delegated authority, hereby declare the following:

1. the medicines listed in Schedule 1 to this notice are classified as prescription medicines.
2. the medicines listed in Schedule 2 to this notice are classified as restricted medicines.
3. the medicines listed in Schedule 3 to this notice are classified as pharmacy-only medicines.

Every reference to a medicine in this notice applies whether the medicine is synthetic in origin or is from biological or mineral sources.

Unless specific reference is made otherwise, every reference applies also to medicines that are:

1. preparations and admixtures containing any proportion of any substance listed in the notice.
2. salts and esters of any substance listed in the notice.
3. preparations or extracts of biological materials listed in the notice.
4. salts or oxides of elements listed in the notice.

Unless specific reference is made otherwise, every reference to a medicine applies:

1. if the medicine is in an injection or eye preparation, to any concentration of that medicine, and
2. if the medicine is not in an injection or eye preparation, only if the concentration of the medicine is greater than 10 milligrams per litre or per kilogram.

Where any reference is modified by a statement of the strength of the medicine, the strength is calculated using the free acid, base, alcohol or element unless specifically stated otherwise.

In accordance with section 106(2) of the Act, to the extent that any part of this notice is inconsistent with any provisions of any regulations made under section 105(1)(j) of the Act, the provisions in those regulations cease to have effect while this notice remains in force.

Schedule 1

Prescription Medicines

Abaloparatide

Abrocitinib

Adrenocorticotropic hormone analogues

AICAR

Alanylglutamine

Allopurinol; except when provided for the prophylaxis of gout to people who meet the clinical and eligibility criteria of an approved training program, when provided by pharmacists who meet the requirements of the Pharmacy Council and the Pharmaceutical Society of New Zealand Incorporated training programme, for a maximum of 3 months’ supply

Amethocaine; for internal use; for external use in medicines containing more than 10%; for ophthalmic use except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board; except when containing 2% or less and used topically as a local anaesthetic in practice by a dental therapist, oral health therapist or dental hygienist (without local anaesthetic exclusion on their scope of practice) registered with the Dental Council

Amivantamab

Andexanet alfa

Anifrolumab

Anti-microbial peptides and their precursors

AOH1996

Arbutin; in oral preparations except herbal preparations containing 500 milligrams or less beta-arbutin per recommended daily dose

Articaine; except when used as a local anaesthetic in practice by a dental therapist, oral health therapist or dental hygienist (without local anaesthetic exclusion on their scope of practice) registered with the Dental Council

Asciminib

Atogepant

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

Avacopan

Avalglucosidase alfa

Avatrombopag

B7-33

Belantamab mafodotin

Belumosudil

Belzutifan

Benzocaine; except when specified elsewhere in this schedule; except in dermal preparations containing 2% or less total anaesthetic substances; except in lozenges containing 30 milligrams or less of total anaesthetic substances per dosage unit; except when containing 20% or less and used topically as a local anaesthetic in practice by a dental therapist, oral health therapist or dental hygienist (without local anaesthetic exclusion on their scope of practice) registered with the Dental Council

Bilastine; except when specified elsewhere in this schedule

Body protective compound 157 and its analogues

Brimonidine; except when specified elsewhere in this schedule

Brompheniramine; except when specified elsewhere in this schedule

Bufexamac

Bulevirtide

Capivasertib

Cardarine

Cariprazine

Casirivimab

Cemiplimab

Cipaglucosidase alfa

Chlorpheniramine; except when specified elsewhere in this schedule

Cilgavimab

Ciltacabtagene autoleucel

Clascoterone

Cyclizine; except when specified elsewhere in this schedule

Danicopan

Danuglipron

Datopotamab deruxtecan

Desloratadine; except when specified elsewhere in this schedule

Deucravacitinib

Deutetrabenazine

Deutivacaftor

Dexchlorpheniramine; except when specified elsewhere in this schedule

Dexrazoxane

Difelikefalin

Diphenhydramine; except when specified elsewhere in this schedule

Diroximel fumarate

Dostarlimab

Doxylamine; except when specified elsewhere in this schedule

Edaravone

Efgartigimod alfa

Elacestrant dihydrochloride

Elafibranor

Elamipretide

Elexacaftor

Elranatamab

Empagliflozin

Emtricitabine; except when supplied for HIV prophylaxis to people who are aged 18 years and older, are HIV negative, and meet the clinical and eligibility criteria of a Pharmaceutical Society of New Zealand approved training programme, when provided by a registered pharmacist who meets the requirements of the Pharmacy Council and who has successfully completed the approved training programme

Enfortumab vedotin

Epcoritamab

Erythropoietin and its analogues

Eslicarbazepine

Estetrol monohydrate

Etesevimab

Etranacogene dezaparvovec

Etrasimod

Faricimab

Fedratinib

Felypressin; except when combined with a local anaesthetic and used in practice by a dental therapist, oral health therapist or dental hygienist (without local anaesthetic exclusion on their scope of practice) registered with the Dental Council

Fenbendazole

Fexofenadine; except for oral use

Fezolinetant

Filgotinib

Finerenone

Foscarbidopa

Foslevodopa

Fostemsavir

Fruquintinib

Futibatinib

Ganaxolone

Garadacimab

Glecaprevir; except when supplied in combination with pibrentasvir in a manufacturer’s original pack that has received consent from the Minister of Health or Director General for treatment of chronic hepatitis C virus infection to people who meet the clinical and eligibility criteria of an approved training programme, when provided by nurses who meet the requirements of the Nursing Council or pharmacists who meet the requirements of the Pharmacy Council

Glofitamab

Glucagon-like peptide-1 receptor agonists

Hyaluronidase

Icosapent ethyl

Imdevimab

Inavolisib

Inclisiran

Inebilizumab

Infigratinib

Iptacopan

Ivosidenib

Kisspeptins

Landiolol

Larazotide

Lazertinib

Lebrikizumab

Lecanemab

Lemborexant

Lenacapavir

Levomefolic acid; for injection

Lignocaine; for injection except when used as a local anaesthetic in practice by a nurse whose scope of practice permits the performance of general nursing functions or by a podiatrist registered with the Podiatry Board or by a dental therapist, oral health therapist or dental hygienist (without local anaesthetic exclusion on their scope of practice) registered with the Dental Council; except when containing 2.5% or less and used topically as a local anaesthetic in practice by a dental therapist, oral health therapist or dental hygienist (without local anaesthetic exclusion on their scope of practice) registered with the Dental Council; for ophthalmic use except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board; for oral use except in throat lozenges in medicines containing 30 milligrams or less per dose form; for external use in medicines containing more than 10%; except in throat sprays in medicines containing 2% or less; except when specified elsewhere in this schedule

Lumasiran

Lurbinectedin

Luspatercept

Maribavir

Marstacimab

Mavacamten

Meclozine; except when specified elsewhere in this schedule

Melatonin; except when supplied in medicines for oral use containing 3mg or less per immediate release dose unit, or 2mg or less per modified release dose unit, when sold in the manufacturers original pack that has received consent from the Minister of Health or the Director General for the treatment of primary insomnia for adults aged 55 years or older for up to 13 weeks by a registered pharmacist; except when specified elsewhere in this schedule

Mepyramine; except when specified elsewhere in this schedule

Mirvetuximab soravtansine

Mitochondria-derived peptides and their analogues

Mobocertinib

Molnupiravir; except when specified elsewhere in this schedule

Momelotinib dihydrochloride

Momelotinib

Myostatin modulator peptides

Naloxone; except when provided as part of an approved emergency kit for the treatment of opioid overdose; except when supplied as ampoules with needles and syringes, or as a prefilled syringe, by those authorised by regulation 3, 4 or 5 of the Health (Needles and Syringes) Regulations 1998 for the treatment of opioid overdose, and when supplied with instructions for use

Naproxen; except when otherwise specified in this schedule

Naratriptan; except when included elsewhere in this schedule

Nelarabine

Nirmatrelvir; except when specified elsewhere in this schedule

Nirsevimab

Nitrofurantoin; except when supplied for oral use containing 100mg per dose unit when sold in a pack of 10 solid dosage units to a woman aged 16–65 years for the first-line empiric treatment of an uncomplicated urinary tract infection by a registered pharmacist who has successfully completed the Pharmaceutical Society of New Zealand training in the treatment of urinary tract infections

Odevixibat

Olopatadine; except when specified elsewhere in this schedule

Onasemnogene abeparvovec

Opicapone

Osilodrostat

Palopegteriparatide

Palovarotene

Paracetamol; except when otherwise specified in this schedule

Patisiran

Pegcetacoplan

Pegunigalsidase alfa

Pegvaliase

Pemigatinib

Pheniramine; except when specified elsewhere in this schedule

Phenol; for injection; except when specified elsewhere in this schedule; except when supplied in a manufacturer’s original pack that has received consent from the Minister or Director-General to a podiatrist registered with the Podiatrists Board of New Zealand for matrixectomy

Pibrentasvir; except when supplied in combination with glecaprevir in a manufacturer’s original pack that has received consent from the Minister of Health or Director General for treatment of chronic hepatitis C virus infection to people who meet the clinical and eligibility criteria of an approved training programme, when provided by nurses who meet the requirements of the Nursing Council or pharmacists who meet the requirements of the Pharmacy Council

Pinaverium bromide

Pineal gland peptides and their analogues

PNC-27

Ponesimod

Pralsetinib

Prilocaine; for injection except when used as a local anaesthetic in practice by a dental therapist, or oral health therapist or dental hygienist (without local anaesthetic exclusion on their scope of practice) registered with the Dental Council; except when specified elsewhere in this schedule except when containing 2.5% or less and used topically as a local anaesthetic in practice by a dental therapist, oral health therapist or dental hygienist (without local anaesthetic exclusion on their scope of practice) registered with the Dental Council

Promethazine; except when specified elsewhere in this schedule

PTD-DBM

Recombinant varicella zoster virus glycoprotein E; except when administered for the prevention of herpes zoster (shingles) to a person 50 years of age or over, or a person aged 18 to 49 years at increased risk of herpes zoster, by a registered pharmacist who has 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 Ministry of Health

Regdanvimab

Relatlimab

Relugolix

Repotrectinib

Respiratory syncytial virus vaccine; 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 a registered pharmacist who has 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

Retratrutide

Rimegepant

Ripretinib

Risdiplam

Ritlecitinib

Ritonavir; except when specified elsewhere in this schedule

Rozanolixizumab

Sacituzumab govitecan

Selinexor

Selumetinib

Sepiapterin

Sodium citrate dihydrate

Somapacitan

Sotatercept

Sotorasib

Sotrovimab

Tebentafusp

Teneligliptin

Tenofovir; except when supplied for HIV prophylaxis to people who are aged 18 years and older, are HIV negative, and meet the clinical and eligibility criteria of a Pharmaceutical Society of New Zealand approved training programme, when provided by a registered pharmacist who meets the requirements of the Pharmacy Council and who has successfully completed the approved training programme

Tepotinib

Teprotumumab

Tezepelumab

Tirzepatide

Tislelizumab

Tixagevimab

Thymic peptide hormones and their analogues

Trabectedin

Trastuzumab deruxtecan

Trifarotene

Tuftsin and its analogues

Vanzacaftor

Velmanase alfa

Vericiguat

Vorasidenib

Vosoritide

Vutrisiran

Zanubrutinib

Zilucoplan

Zinc; except for internal use in medicines containing 25 milligrams or less per recommended daily dose; except for internal use in medicines containing 50 milligrams or less and more than 25 milligrams per recommended daily dose in packs that have received the consent of the Minister or the Director-General to their distribution as general sale medicines, when sold in the manufacturer’s original pack and when labelled with a statement that the product may be dangerous if taken in large amounts or for long periods; except for external use except when specified elsewhere in this schedule; except in parenteral nutrition replacement preparations

Zolbetuximab.

Schedule 2

Restricted Medicines

Adrenaline; 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

Brompheniramine; for oral use in medicines for adults or children over 6 years of age other than in medicines used for sedation or the treatment of insomnia; for oral use for the treatment of insomnia in adults and children 12 years of age and older when sold in the manufacturer’s original pack containing not more than 10 dosage units; for oral use for sedation in adults only when sold in the manufacturer’s original pack

Cannabidiol; when supplied, in medicines with dosing instructions for 150 milligrams or less per day and containing not more than 4.5 grams, when sold in the manufacturer’s original pack that has received consent from the Minister or Director-General, for adults aged 18 years and over, by a registered pharmacist

Chlorpheniramine; for oral use in medicines for adults or children over 6 years of age other than in medicines used for sedation or the treatment of insomnia; for oral use for the treatment of insomnia in adults and children 12 years of age and older when sold in the manufacturer’s original pack containing not more than 10 dosage units; for oral use for sedation in adults only when sold in the manufacturer’s original pack

Choline Salicylate; in medicines containing 10% or less and in packs sizes of 15 grams or less when indicated for use in children under 18 months of age

Cyclizine; for oral use in medicines for adults and children over 6 years of age other than in medicines for the treatment of insomnia when sold in the manufacturer’s original pack containing not more than 6 dosage units; for oral use in medicines used for the treatment of insomnia in adults and children 12 years of age and older when sold in the manufacturer’s original pack containing not more than 10 dosage units; for oral use for sedation in adults only when sold in the manufacturer’s original pack containing not more than 6 dosage units

Cytisine; in divided oral and oromucosal preparations as an aid in withdrawal from nicotine dependence in adults

Dexchlorpheniramine; for oral use in medicines for adults or children over 6 years of age other than in medicines used for sedation or the treatment of insomnia; for oral use for the treatment of insomnia in adults and children 12 years of age and older when sold in the manufacturer’s original pack containing not more than 10 dosage units; for oral use for sedation in adults only when sold in the manufacturer’s original pack

Diphenhydramine; for oral use in medicines for adults or children over 6 years of age other than in medicines used for sedation or the treatment of insomnia; for oral use for the treatment of insomnia in adults and children 12 years of age and older when sold in the manufacturer’s original pack containing not more than 10 dosage units; for oral use for sedation in adults only when sold in the manufacturer’s original pack

Doxylamine; for oral use in medicines for adults or children over 6 years of age other than in medicines used for sedation or the treatment of insomnia; for oral use for the treatment of insomnia in adults and children 12 years of age and older when sold in the manufacturer’s original pack containing not more than 10 dosage units; for oral use for sedation in adults only when sold in the manufacturer’s original pack

Ibuprofen 300 milligrams in powder form; for oral use in powder form containing 300 milligrams per dose with a recommended daily dose of not more than 1.2 grams and sold in the manufacturers original packs containing not more than 12 dose units, and labelled for use in adults and children over 12 years of age

Meclozine; for oral use for the treatment of insomnia in adults and children over 12 years of age when sold in the manufacturer’s original pack containing not more than 10 dosage units

Mepyramine; for oral use in medicines for adults or children over 6 years of age other than in medicines used for sedation or the treatment of insomnia; for oral use for the treatment of insomnia in adults and children 12 years of age and older when sold in the manufacturer’s original pack containing not more than 10 dosage units; for oral use for sedation in adults only when sold in the manufacturer’s original pack

Methenamine hippurate

Molnupiravir; for use in the treatment of COVID-19

Naproxen; in solid dose forms in medicines containing 250 milligrams or less per dose form in packs containing not more than 30 tablets or capsules and with a recommended daily dose of more than 750 milligrams

Naratriptan; when divided in oral preparations containing 2.5 milligrams or less of naratriptan per dosage unit and when sold in a pack containing not more than 2 dosage units for the acute relief of migraine in patients who have a stable, well-established pattern of symptoms

Nirmatrelvir; for use in the treatment of COVID-19

Paracetamol; in modified-release forms containing 665 milligrams or less, in liquid form in packs containing more than 10 grams and not more than 50 grams

Pheniramine; for oral use in medicines for adults or children over 6 years of age other than in medicines used for sedation or the treatment of insomnia; for oral use for the treatment of insomnia in adults and children 12 years of age and older when sold in the manufacturer’s original pack containing not more than 10 dosage units; for oral use for sedation in adults only when sold in the manufacturer’s original pack

Pholcodine; in medicines for oral use containing not more than 15 milligrams of pholcodine per solid dosage unit or per dose of liquid with a maximum daily dose not exceeding 100 milligrams of pholcodine, when combined with 1 or more active ingredients in such a way that the substance cannot be recovered by readily applicable means, or in a yield that would constitute a risk to health, when sold in a pack approved by the Minister or the Director-General for distribution as a restricted medicine

Promethazine; for oral use in medicines for adults or children over 6 years of age other than in medicines used for sedation or the treatment of insomnia; for oral use for the treatment of insomnia in adults and children 12 years of age and older when sold in the manufacturer’s original pack containing not more than 10 dosage units; For oral use for sedation in adults only when sold in the manufacturer’s original pack

Ritonavir; for use in the treatment of COVID-19.

Schedule 3

Pharmacy-only Medicines

Atropa belladonna; for external use in medicines containing 0.03% or less of the alkaloids of belladonna; for oral use in adults and children 6 years of age and over 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

Bilastine; for oral use; for ophthalmic use in adults except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board

Brimonidine; in ophthalmic preparations containing not more than 0.025% brimonidine

Brompheniramine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other therapeutically active ingredients either when in the bedtime dose of a day/night pack containing brompheniramine or when at least 1 of the other active ingredients is a sympathomimetic decongestant

Chlorpheniramine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other therapeutically active ingredients either when in the bedtime dose of a day/night pack containing chlorpheniramine or when at least 1 of the other active ingredients is a sympathomimetic decongestant

Desloratadine; for oral use; except in divided solid dosage forms for oral use containing 5 milligrams or less per dose form for the treatment of seasonal allergic rhinitis when sold in the manufacturer’s original pack containing not more than 10 days’ supply

Dexchlorpheniramine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other therapeutically active ingredients either when in the bedtime dose of a day/night pack containing dexchlorpheniramine or when at least 1 of the other active ingredients is a sympathomimetic decongestant

Diphenhydramine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other therapeutically active ingredients either when in the bedtime dose of a day/night pack containing diphenhydramine or when at least 1 of the other active ingredients is a sympathomimetic decongestant; for oral use when sold in the manufacturer’s original pack of not more than 10 tablets or capsules for the prevention or treatment of motion sickness in adults and children over 6 years of age except when sold at a transport terminal or aboard a ship or aircraft for adults and children over 6 years of age

Doxylamine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other therapeutically active ingredients either when in the bedtime dose of a day/night pack containing doxylamine or when at least 1 of the other active ingredients is a sympathomimetic decongestant

Fexofenadine; for oral use except for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when in capsules containing 60 milligrams or less of fexofenadine hydrochloride or in tablets containing 120 milligrams or less of fexofenadine hydrochloride with a maximum daily dose of 120 milligrams when sold in the manufacturer’s original pack containing 20 dosage units or less and not more than 10 days’ supply; for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when in tablets containing 180 milligrams or less of fexofenadine hydrochloride with a maximum daily dose of 180 milligrams when sold in the manufacturer’s original pack containing 10 dosage units or less and not more than 10 days’ supply

Folic acid; For oral use in medicines containing more than 500 micrograms per recommended daily dose. When the medicine contains a combination of folic acid, folinic acid or levomefolic acid, the medicine must not provide more than a combined total of 500 micrograms of folic acid, folinic acid and levomefolic acid per maximum recommended daily dose

Folinic acid; For oral use in medicines containing more than 500 micrograms per recommended daily dose. When the medicine contains a combination of folic acid, folinic acid or levomefolic acid, the medicine must not provide more than a combined total of 500 micrograms of folic acid, folinic acid and levomefolic acid per maximum recommended daily dose

Levomefolic acid; for oral use in medicines containing more than 500 micrograms per recommended daily dose. When the medicine contains a combination of folic acid, folinic acid or levomefolic acid, the medicine must not provide more than a combined total of 500 micrograms of folic acid, folinic acid and levomefolic acid per maximum recommended daily dose

Meclozine; when sold in the manufacturer’s original pack of not more than 12 tablets or capsules for the prevention or treatment of travel sickness in adults and children over 6 years of age except when sold at a transport terminal or aboard a ship or aircraft for adults and children over 6 years of age

Melatonin; when supplied in medicines for oral use in immediate release preparations containing 5mg or less per dose unit for the treatment of jet lag in adults aged 18 or over, containing not more than 10 days’ supply, in the manufacturers original pack that has received consent from the Minister or Director-General for sale as a pharmacy only medicine; when supplied in medicines for oral use containing 3mg or less per immediate release dose unit, or 2mg or less per modified release dose unit, for the treatment of primary insomnia for adults aged 18 years or older, containing not more than 30 days’ supply, in the manufacturers original pack that has received consent from the Minister or Director-General

Mepyramine; for dermal use except for external use in medicines containing 2% or less in packs not exceeding 25 grams

Naproxen; in solid dose forms containing 250 milligrams or less per dose form in packs containing not more than 30 tablets or capsules and with a recommended daily dose of not more than 750 milligrams

Olopatadine; in preparations for nasal use delivering 600 micrograms or less of olopatadine per dose when the maximum recommended daily dose is no greater than 4,800 micrograms for the treatment of allergic rhinitis or rhinoconjunctivitis for up to 6 months in adults and children 12 years of age and over

Paracetamol; in liquid form in packs containing not more than 10 grams; in suppositories; in tablets or capsules containing 500 milligrams or less and in packs containing more than 10 grams and not more than 50 grams; in powder form containing not more than 1 gram per sachet and more than 10 grams per pack; except in tablets or capsules containing 500 milligrams or less and in packs containing not more than 10 grams; except in powder form in sachets containing 1 gram or less and in packs of not more than 10 grams

Pheniramine; for ophthalmic use except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other therapeutically active ingredients either when in the bedtime dose of a Pharmacy day/night pack containing pheniramine or when at least 1 of the other active ingredients is a sympathomimetic decongestant

Phenol; in medicines other than for injection containing more than 3% other than for matrixectomy

Promethazine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other therapeutically active ingredients either when in the bedtime dose of a day/night pack containing promethazine or when at least 1 of the other active ingredients is a sympathomimetic decongestant; for oral use when sold in the manufacturer’s original pack of not more than 10 tablets or capsules for the prevention or treatment of motion sickness in adults and children over 6 years of age except when sold at a transport terminal or aboard a ship or aircraft for adults and children over 6 years of age.

Dated this 17th day of December 2025.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health.