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Revised: 20 December 2016

Recent New Zealand Gazette Notices Relating to Classification

27 October 2016
18 August 2016
18 August 2016 - Out of session
11 August 2016

27 October 2016 – Out of session meeting

This notice implements recommendations made from an out of session Medicine Classification Committee meeting that took place on 20 October 2016.

Prescription Medicines

Velpatasvir

18 August 2016

This notice implements recommendations from the  55th meeting of the Medicines Classification Committee held on 3 May 2016

Prescription Medicines

Adapalene; except in medicines containing 1 milligram or less per millilitre or gram and when supplied by a pharmacist in a pack containing not more than 30 grams for the treatment of comedo, papular and pustular acne (acne vulgaris) of the face, chest or back

Cobimetinib

Esomeprazole; except when specified elsewhere in this schedule

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 dental therapist registered with the Dental Council; for oral use; for ophthalmic use except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board; except when specified elsewhere in this schedule; except for external use and in throat sprays in medicines containing 2% or less; in throat lozenges in medicines containing 30 milligrams or less per dose form

Loratadine; except when specified elsewhere in this schedule; except in divided solid dosage forms for oral use containing 10 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 ten days’ supply

Naloxone; except when provided as part of an approved emergency kit for the treatment of opioid overdose

Ramucirumab

Sacubitril.

Pharmacy-only Medicines

Esomeprazole; in divided solid dosage forms for oral use containing 20 milligrams or less with a maximum daily dose of 20 milligrams for the short-term symptomatic relief of gastro-oesophageal reflux-like symptoms in sufferers aged 18 years and over when sold in the manufacturer’s original pack containing not more than seven dosage units

Loratadine; for oral use; except in divided solid dosage forms for oral use containing 10 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 ten days’ supply.

Medicines for General Sale

Please note that the following medicines are now available for general sale.

Lignocaine; for external use and in throat sprays in medicines containing 2% or less; in throat lozenges in medicines containing 30 milligrams or less per dose form

Loratadine; in divided solid dosage forms for oral use containing 10 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 ten days’ supply.

18 August 2016 – Out of session meeting

This notice implements recommendations made from an out of session Medicine Classification Committee meeting that took place on 9 August 2016.

11 August 2016

The most recent update to the First Schedule to the Medicines Regulations 1984, Medicines Amendment Regulations (No 2) 2015, came into effect on 6 August 2015. This notice keeps in effect Gazette notices published after 6 August 2015.

Prescription Medicines

Alectinib

Alirocumab

Aloracetam

Amifampridine

Aniracetam

AOD-9604

Apremilast

Artesunate

Asunaprevir

Azelastine; except when specified elsewhere in this notice

Bedaquiline

Benzbromarone

Benzydamine; except for oromucosal or topical use

Bilastine; except when specified elsewhere in this notice

Bosutinib

Brentuximab vedotin

Brivaracetam (and its stereoisomers)

Carglumic acid

Cebaracetam (and its stereoisomers)

Cholic acid

CJC-1295

Coluracetam

Daclatasvir

Defibrotide

Dimiracetam (and its stereoisomers)

Doliracetam (and its stereoisomers)

Dupracetam

Elbasvir

Elosulfase alfa

Etiracetam

Fasoracetam (and its stereoisomers)

Felbamate

Flunarizine

Fomepizole

Fonturacetam (and its stereoisomers)

Grazoprevir

Growth Hormone Releasing Hormones

Growth Hormone Releasing Peptide-6

Growth Hormone Releasing Peptides

Idarucizumab

Idebenone

Idelalisib

Imuracetam

Influenza vaccine; except when administered to a person 13 years of age or over by a registered 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

Ketoprofen; except when specified elsewhere in this notice

Lesinurad

Levomilnacipran

Mepolizumab

Methylhexanamine (1,3-dimethylamylamine (DMAA)); except when present as an unmodified, naturally occurring substance

Milnacipran

Molracetam

Naloxegol

Nebracetam (and its stereoisomers)

Nefiracetam

Nepidermin

Netupitant

Nicoracetam

Nitazoxanide

Nivolumab

Noopept (and its stereoisomers)

Olaparib

Otilonium bromide

Oxiracetam (and its stereoisomers)

Paritaprevir

Peginterferon beta-1a

Pembrolizumab

Pentostatin

Picibanil

Piperacetam

Pirfenidone

Ponatinib

Pralmorelin

Pramiracetam

Ranitidine; except when specified elsewhere in this schedule; except in medicines containing 300 milligrams or less per dose unit when sold in the manufacturer’s original pack containing not more than seven days’ supply

Ranolazine

Recombinant human Epidermal Growth Factor

Rolipram (and its stereoisomers)

Rolziracetam

Rufinamide

Sargramostim

Secukinumab

Seletracetam (and its stereoisomers)

Sodium phenylbutyrate

Stiripentol

Streptozocin

Sunifiram

Suvorexant

Tizanidine

Trientine

Ulipristal.

Restricted Medicines

Cyclizine; for oral use other than in medicines used for the treatment of anxiety or insomnia when sold in the manufacturer’s original pack containing not more than six dosage units; for oral use in medicines used for the treatment of anxiety or insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units

Ketoprofen; in solid dose form containing 25 milligrams or less per dose form in packs of not more than 30 capsules or tablets.

Pharmacy-only Medicines

Azelastine; in preparations for nasal use containing 0.15% azelastinehydrochloride or less; in topical eye preparations containing 0.05% or less

Bilastine; in divided solid dosage forms for oral use containing20 milligrams or less for the treatment of the symptoms of allergic rhinoconjunctivitis (seasonal and perennial) and urticaria when sold in a pack containing not more than 30 dosage units

Macrogols; in preparations for oral use as a liquid concentrate for laxative use

Ranitidine; in medicines for the symptomatic relief of heartburn, dyspepsia and hyperacidity or to be used on the recommendation of a registered medical practitioner when sold in the manufacturer's original pack containing not more than 14 days’ supply; except in medicines containing 300 milligrams or less per dose unit when sold in the manufacturer’s original pack containing not more than seven days’ supply.

Medicines for General Sale

Please note that the following medicines are now available for general sale.

 Benzydamine; for oromucosal or topical use

Efmoroctocog alfa

Simoctocog alfa

Ranitidine; in medicines containing 300 milligrams or less per dose unit when sold in the manufacturer’s original pack containing not more than seven days’ supply.

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