Pursuant to section 106(1) of the Medicines Act 1981, I, Chris James, Group Manager, Medsafe, Ministry of Health, acting under delegated authority, hereby declare the following:
- The medicines listed in Schedule 1 to this notice are classified as prescription medicines.
- The medicines listed in Schedule 2 to this notice are classified as restricted medicines.
- 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:
- preparations and admixtures containing any proportion of any substance listed in the notice.
- salts and esters of any substance listed in the notice.
- preparations or extracts of biological materials listed in the notice.
- salts or oxides of elements listed in the notice.
Unless specific reference is made otherwise, every reference to a medicine applies:
- if the medicine is in an injection or eye preparation, to any concentration of that medicine; and
- 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
Apalutamide
Bictegravir
Binimetinib
Cabozantinib
Cinnarizine
Encorafenib
Erenumab
Ertugliflozin
Etomidate
Ferric derisomaltose
Guselkumab
Letermovir
Insulin deglude
Nusinersen
Patiromer sorbitex calcium
Peramivir
Phenibut
Recombinant varicella zoster virus glycoprotein E antigen
Reslizumab
Ribociclib
Rilmazafone
Tafenoquine succinate
Telotristat ethyl
Tipiracil
Trifluridine
Schedule 2
Restricted Medicines
Brompheniramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of insomnia; for oral use for the treatment of insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units.
Chlorpheniramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of insomnia; for oral use for the treatment of insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units.
Cyclizine; for oral use other than in medicines used for the treatment of insomnia when sold in the manufacturer’s original pack containing not more than 6 dosage units; for oral use in medicines used for the treatment of insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units.
Dexchlorpheniramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of insomnia; for oral use for the treatment of insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units.
Diphenhydramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of insomnia; for oral use for the treatment of insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units.
Doxylamine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of insomnia; for oral use for the treatment of insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units.
Meclozine; in a pack size of up to 10 dosage units for the treatment of insomnia.
Mepyramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of insomnia; for oral use for the treatment of insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units.
Pheniramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of insomnia; for oral use for the use of the treatment of insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units.
Promethazine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of insomnia; for oral use for the treatment of insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units.
Trimeprazine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of insomnia; for oral use for the treatment of insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units.
Schedule 3
Pharmacy-only Medicines
Esomeprazole; in oral preparations containing 20 milligrams or less per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days supply.
Dated this 15th day of August 2018.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health.