Pursuant to section 106(1) of the Medicines Act 1981, I, Chris James, Acting Group Manager, Medsafe, Ministry of Health, acting under delegated authority since 11 September 2013, 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.

Schedule 1

Prescription Medicines

Alectinib

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

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)

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

Schedule 2

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

Schedule 3

Pharmacy-only Medicines

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

Bilastine; in divided solid dosage forms for oral use containing 20 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.

Dated this 7th day of July 2016.

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