Revised: 30 March 2021

Committees

Recent New Zealand Gazette Notices Relating to Classification

The most recent update to the First Schedule to the Medicines Regulations 1984, Medicines Amendment Regulations 2018, came into effect on 7 November 2018. Please note that Gazette notices published after 7 November 2018 (listed above) need to be taken into account when seeking the classification of a medicine.

The current classification of a medicine may also be found in the Classification Database.

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4 March 2021 (2021-go-609)
16 February 2021 (2021-go498)
17 December 2020 (2020-go5682)
4 December 2020 (2020-go5551)
5 November 2020 (2020-go5093)
28 October 2020 (2020-go4860)
19 October 2020 (2020-go4832)
18 May 2020 (2020-go1183)
20 March 2020 (2020-go1191)
6 March 2020
19 December 2019
1 November 2019
20 September 2019
12 July 2019
24 June 2019
25 February 2019

4 March 2021 (2021-go609)

Prescription Medicines

Acalabrutinib
Alitretinoin
Brolucizumab
Cabotegravir
Cedazuridine
Decitabine
Enasidenib
Fosnetupitant
Fremanezumab
Gilteritinib
Indocyanine green
Isatuximab
Larotrectinib
Ozanimod
Siponimod
Tafamidis
Tucatinib
Voretigene neparvovec

Medicines for General Sale

Fexofenadine; 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.

Fexofenadine; for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when in tablets containing 180mg or less of fexofenadine hydrochloride with maximum daily dose of 180mg when sold in the manufacturer’s original pack containing 5 dosage units or less and not more than 5 days’ supply.

16 February 2021 (2021-go498)

Prescription Medicines

COVID-19 Vaccines; except when administered by a vaccinator who has successfully completed a training course approved by the Ministry of Health and who complies with the immunisation standards of the Ministry of Health.

17 December 2020 (2020-go5682)

Prescription Medicines

Bamlanivimab
Dulaglutide
Remdesivir

4 December 2020 (2020-go5551)

Prescription Medicines

Abemaciclib
Alkyl nitrites
Alpelisib
Artemisia annua extract
Avelumab
Avibactam
Baricitinib
Baloxavir marboxil
Benralizumab
Blinatumomab
Brigatinib
Budesonide; except when specified elsewhere in this notice.
Cenegermin
Cerliponase alfa
Cilnidipine
Codeine
Crisaborole
Daratumumab
Darolutamide
Dextromethorphan; except when specified elsewhere in this notice.
DMHA including the isomers 2-amino-6-methylhelptane (also known as 1,5-dimethylhexylamine, and octodrine) and 2-amino-5-methylheptane (also known as 1,4-dimethylhexamine).
Doravirine
Durvalumab
Entrectinib
Esketamine
Galcanezumab
Fluticasone; except when specified elsewhere in this notice.

Human papillomavirus vaccine; except when administered by a registered pharmacist or registered intern pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health.

Ibutamoren
Inotuzumab ozogamicin
Isavuconazole
Lanadelumab
Lifitegrast
Linaclotide
Lorlatinib

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.

Meldonium
Metamizole
Methylphenylpiracetam
Midostaurin
Neratinib
Niraparib
Obeticholic acid
Olaratumab
Omberacetam
Opium
Phenylpiracetam
Plitidepsin
Polatuzumab vedotin
Racetams; except when specified elsewhere in this notice.
Risankizumab
Romosozumab
Safinamide
Squill
Stenabolic (SR9009) and other synthetic REV-ERB agonists
Talazoparib
Tezacaftor
Tilmanocept
Tivozanib
Unifiram
UpadacitinibVoglibose
Voxilaprevir

Restricted Medicines

Dextromethorphan; in liquid form when in packs containing not more than 600 milligrams and with a recommended daily dose of not more than 120 milligrams; in medicines for the treatment of symptoms of cough and cold in adults and children aged 6 years and over.

Paracetamol; in modified-release forms containing 665 milligrams or less.

Pharmacy-only Medicines

Bilastine; in divided solid dosage forms for oral use containing 20 milligrams or less for the treatment of the symptoms of allergic rhinoconjuctivitis (seasonal and perennial) and urticaria.

Budesonide; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age in aqueous nasal sprays delivering up to 64 micrograms per actuation and when the maximum recommended daily dose is no greater than 400 micrograms (200 micrograms per nostril).

Fluticasone; 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).

Paracetamol; in liquid form; 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.

5 November 2020 (2020-go5093)

Prescription Medicines

Codeine

28 October 2020 (2020-go4860)

Prescription Medicines

Measles vaccine; except when administered in combination with mumps and rubella vaccines in a combination product the supply of which the Minister of Health has given consent, by a vaccinator who has successfully completed a training course approved by the Ministry of Health and who complies with the immunisation standards of the Ministry of Health.

Mumps vaccine; except when administered in combination with measles and rubella vaccines in a combination product the supply of which the Minister of Health has given consent, by a vaccinator who has successfully completed a training course approved by the Ministry of Health and who complies with the immunisation standards of the Ministry of Health.

Rubella vaccine; except when administered in combination with mumps and measles vaccines in a combination product the supply of which the Minister of Health has given consent, a vaccinator who has successfully completed a training course approved by the Ministry of Health and who complies with the immunisation standards of the Ministry of Health.

19 October 2020 (2020-go4832)

Prescription Medicines

Alpelisib
Baloxavir marboxil
Cilnidipine
Darolutamide

Human papillomavirus vaccine; except when administered by a registered pharmacist or registered intern pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health.

Lorlatinib
Niraparib
Talazoparib

18 May 2020 (2020-go1183)

Prescription Medicines

Artemisia annua extract

29 April 2020 (2020-go1806)

Prescription Medicines

Measles vaccine; except when specified elsewhere in this notice.
Mumps vaccine; except when specified elsewhere in this notice.
Rubella vaccine; except when specified elsewhere in this notice.

Pharmacy-only Medicines

Measles vaccine when administered in combination with mumps and rubella vaccines in a combination product the supply of which the Minister of Health has given consent, by a vaccinator who has successfully completed a training course approved by the Ministry of Health and who complies with the immunisation standards of the Ministry of Health.

Mumps vaccine when administered in combination with measles and rubella vaccines in a combination product the supply of which the Minister of Health has given consent, by a vaccinator who has successfully completed a training course approved by the Ministry of Health and who complies with the immunisation standards of the Ministry of Health.

Rubella vaccine when administered in combination with mumps and measles vaccines in a combination product the supply of which the Minister of Health has given consent, a vaccinator who has successfully completed a training course approved by the Ministry of Health and who complies with the immunisation standards of the Ministry of Health.

20 March 2020 (2020-go1191)

Prescription Medicines

Avelumab
Baricitinib
Benralizumab
Blinatumomab
Brigatinib
Budesonide; except when specified elsewhere in this notice.
Cerliponase alfa
Crisaborole
Daratumumab
Dextromethorphan; except when specified elsewhere in this notice.
Durvalumab
Fluticasone; except when specified elsewhere in this notice.
Ibutamoren
Inotuzumab ozogamicin
Lanadelumab
Lifitegrast
Linaclotide

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.

Midostaurin
Neratinib
Obeticholic acid
Olaratumab
Opium
Polatuzumab vedotin
Risankizumab
Romosozumab
Safinamide
Squill
Stenabolic (SR9009) and other synthetic REV-ERB agonists
Tezacaftor
Tilmanocept
Tivozanib
Voxilaprevir

Restricted Medicines

Dextromethorphan; in liquid form when in packs containing not more than 600 milligrams and with a recommended daily dose of not more than 120 milligrams; in medicines for the treatment of symptoms of cough and cold in adults and children aged 6 years and over.

Paracetamol; in modified-release forms containing 665 milligrams or less.

Pharmacy-only Medicines

Budesonide; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age in aqueous nasal sprays delivering up to 64 micrograms per actuation and when the maximum recommended daily dose is no greater than 400 micrograms (200 micrograms per nostril).

Fluticasone; 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).

Paracetamol; in liquid form; 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.

6 March 2020 (2019-go1038)

Prescription medicines

Abemaciclib
Alkyl nitrites; except when specified elsewhere in the schedule
Aniracetam
Avibactam
Bilastine; except when specified elsewhere in this notice
Cenegermin
Coluracetam
Dimiracetam
DMHA including the isomers 2-amino-6-methylhelptane (also known as 1,5-dimethylhexylamine, and octodrine) and 2-amino-5-methylheptane (also known as 1,4-dimethylhexamine)
Doravirine
Entrectinib
Esketamine
Fasoracetam
Galcanezumab

Influenza vaccine; except when administered to a person 13 years of age or over by a registered pharmacist or registered intern pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health

Isavuconazole
Lanadelumab
Meldonium
Metamizole
Methylphenylpiracetam
Nebracetam
Nefiracetam
Omberacetam
Oxiracetam
Phenylpiracetam
Plitidepsin
Pramiracetam
Racetams; except when specified elsewhere in this notice
Rolziracetam
Seletracetam
Semaglutide
Sunifiram
Unifiram
Upadacitinib
Voglibose

Pharmacy-only medicines

Bilastine; in divided solid dosage forms for oral use containing 20 milligrams or less for the treatment of the symptoms of allergic rhinoconjuctivitis (seasonal and perennial) and urticaria.

19 December 2019 (2019-go5772)

Prescription Medicines

Polatuzumab vedotin

1 November 2019 (2019-go5030)

Prescription Medicines

Measles vaccine; except when specified elsewhere in this notice

Mumps vaccine; except when specified elsewhere in this notice

Rubella vaccine; except when specified elsewhere in this notice

Pharmacy-only Medicines

Measles vaccine when administered in combination with mumps and rubella vaccines in a combination product the supply of which the Minister of Health has given consent, by a vaccinator who has successfully completed a training course approved by the Ministry of Health and who complies with the immunisation standards of the Ministry of Health

Mumps vaccine when administered in combination with measles and rubella vaccines in a combination product the supply of which the Minister of Health has given consent, by a vaccinator who has successfully completed a training course approved by the Ministry of Health and who complies with the immunisation standards of the Ministry of Health

Rubella vaccine when administered in combination with mumps and measles vaccines in a combination product the supply of which the Minister of Health has given consent, a vaccinator who has successfully completed a training course approved by the Ministry of Health and who complies with the immunisation standards of the Ministry of Health

20 September 2019 (2019-go4411)

Prescription Medicines

Avelumab
Baricitinib
Benralizumab
Blinatumomab
Brigatinib
Budesonide; except when specified elsewhere in this notice
Cerliponase alfa
Crisaborole
Daratumumab
Dextromethorphan; except when specified elsewhere in this notice
Durvalumab
Fluticasone; except when specified elsewhere in this notice
Ibutamoren
Inotuzumab ozogamicin
Lanadelumab
Lifitegrast
Linaclotide

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.

idostaurin
Neratinib
Obeticholic acid
Olaratumab
Opium
Risankizumab
Romosozumab
Safinamide
Squill
Stenabolic (SR9009) and other synthetic REV-ERB agonists
Tezacaftor
Tilmanocept
Tivozanib
Voxilaprevir

Restricted Medicines

Dextromethorphan; in liquid form when in packs containing not more than 600 milligrams and with a recommended daily dose of not more than 120 milligrams; in medicines for the treatment of symptoms of cough and cold in adults and children aged 6 years and over

Paracetamol; in modified-release forms containing 665 milligrams or less

Pharmacy-only Medicines

Budesonide; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age in aqueous nasal sprays delivering up to 64 micrograms per actuation and when the maximum recommended daily dose is no greater than 400 micrograms (200 micrograms per nostril)

Fluticasone; 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)

Paracetamol; in liquid form; 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

12 July 2019 (2019-go3281)

Prescription Medicines

Brigatinib
Budesonide; except when specified elsewhere in this notice
Crisaborole
Fluticasone; except when specified elsewhere in this notice
Lanadelumab
Romosozumab
Safinamide
Tilmanocept
Tivozanib

Pharmacy-only Medicines

Budesonide; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age in aqueous nasal sprays delivering up to 64 micrograms per actuation and when the maximum recommended daily dose is no greater than 400 micrograms (200 micrograms per nostril)

Fluticasone; 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)

24 June 2019 (2019-go2911)

Prescription Medicines

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.

25 February 2019 (2019-go841)

Prescription Medicines

Avelumab
Baricitinib
Benralizumab
Blinatumomab
Cerliponase alfa
Daratumumab
Dextromethorphan; except when specified elsewhere in this notice
Durvalumab
Ibutamoren
Inotuzumab ozogamicin
Lifitegrast
Linaclotide
Midostaurin
Neratinib
Obeticholic acid
Olaratumab
Opium
Risankizumab
Squill
Stenabolic (SR9009) and other synthetic REV-ERB agonists
Tezacaftor
Voxilaprevir

Restricted Medicines

Dextromethorphan; in liquid form when in packs containing not more than 600 milligrams and with a recommended daily dose of not more than 120 milligrams; in medicines for the treatment of symptoms of cough and cold in adults and children aged 6 years and over

Paracetamol; in modified-release forms containing 665 milligrams or less

Pharmacy-only Medicines

Paracetamol; in liquid form; 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