Revised: 25 July 2019

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.


12 July 2019
24 June 2019
25 February 2019

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

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