Pursuant to section 106(1) of the Medicines Act 1981, I, Dr Don Mackie, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, 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.

Schedule 1

Prescription Medicines

Aloracetam

Aniracetam

Azelastine; except when specified elsewhere in this notice

Bilastine; except when specified elsewhere in this notice

Bosutinib

Brentuximab vedotin

Brivaracetam (and its stereoisomers)

Carglumic acid

Cebaracetam (and its stereoisomers)

Coluracetam

Dimiracetam (and its stereoisomers)

Doliracetam (and its stereoisomers)

Dupracetam

Etiracetam

Elosulfase alfa

Fasoracetam (and its stereoisomers)

Fomepizole

Fonturacetam (and its stereoisomers)

Idarucizumab

Idelalisib

Imuracetam

Ketoprofen; except when specified elsewhere in this notice

Molracetam

Nebracetam (and its stereoisomers)

Nefiracetam

Nepidermin

Nicoracetam

Noopept (and its stereoisomers)

Otilonium bromide

Oxiracetam (and its stereoisomers)

Paritaprevir

Peginterferon beta-1a

Pembrolizumab

Pirfenidone

Piperacetam

Pramiracetam

Ranolazine

Recombinant human Epidermal Growth Factor

Rolipram (and its stereoisomers)

Rolziracetam

Secukinumab

Seletracetam (and its stereoisomers)

Suvorexant

Schedule 2

Restricted Medicines

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

Medicines for General Sale

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

Efmoroctocog alfa

Simoctocog alfa

Dated this 10th day of August 2015.

Dr DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health.