Classification of Medicines
Recent NZ Gazette Notices Relating to Classification
2 February 2012
Gazette notice for 2 February 2012. This notice puts in effect the changes recommended by the Medicines Classification Committee at its 46th meeting on Tuesday 15 November 2011 and keeps in effect changes recommended at the 45th meeting on Tuesday 12 April 2011. This cumulative notice also keeps in effect changes published in Gazette notices on 18 August 2011 and 8 September 2011.
Prescription Medicines
5-aminolevulinic acid
Afamelanotide
Amorolfine; except when specified elsewhere in this schedule; except in preparations for the treatment of tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
Apixaban
Asenapine
Belimumab
Boceprevir
Cyclizine; except when specified elsewhere in this schedule
Clotrimazole; except in medicines for vaginal or external use
Dapagliflozin propanediol
Degarelix
Denosumab
Diclofenac; in preparations for the treatment of solar keratosis; except when specified elsewhere in this schedule; except in preparations for external use other than for the treatment of solar keratosis
Dronedarone
Econazole; except in medicines for vaginal or dermal use
Eculizumab
Ferric carboxymaltose
Fingolimod
Guaiphenesin; for oral use in medicines containing more than 2% or 200 milligrams per dose form except when specified elsewhere in this schedule; except for oral use in modified release form with a maximum recommended daily dose of not more than 2.4 grams when sold in the manufacturer's original pack containing not more than 10 days' supply
Icatibant
Indacaterol
Ipilimumab
Isoconazole; except in medicines for vaginal or dermal use
Linagliptin
Lovastatin; except when present as an unmodified, naturally occurring substance in a food that has not been subject to a manufacturing process other than heating, freezing, drying, preserving, bottling, canning, or packaging in retort pouches
Mercurochrome; except when specified elsewhere in this schedule
Miconazole; except when specified elsewhere in this schedule; except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
Nitisinone
Nomegestrol
Nystatin; except when specified elsewhere in this schedule; except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
Ofatumumab
Omeprazole; except when specified elsewhere in this schedule
Pantoprazole; except when specified elsewhere in this schedule
Plerixafor
Prucalopride
Pseudoephedrine
Remestemcel-L
Rilpivirine
Rupatadine
Sapropterin
Tafluprost
Telaprevir
Terbinafine; except in medicines for dermal use
Ticagrelor
Tioconazole; except in medicines for vaginal or dermal use
Tolvaptan
Tuberculin
Vemurafenib
Vorinostat
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 anxiety or insomnia; for oral use for the treatment of anxiety or 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 anxiety or insomnia; for oral use for the treatment of anxiety or insomnia when sold in the manufacturer's original pack containing not more than 10 dosage units
Cimetidine; in medicines for the symptomatic relief of heartburn, dyspepsia and hyperacidity or to be used on the recommendation of a registered medical practitioner that are sold in the manufacturer's original pack containing not more than 14 days' supply
Cyclizine; for oral use other than in medicines used for the treatment of anxiety or insomnia; for oral use for the treatment of anxiety or 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 anxiety or insomnia; for oral use for the treatment of anxiety or insomnia when sold in the manufacturer's original pack containing not more than 10 dosage units
Diclofenac; in solid dose form in medicines containing 25 milligrams or less and more than 12.5 milligrams per dose form in packs containing not more than 30 tablets or capsules
Diphenhydramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of anxiety or insomnia; for oral use for the treatment of anxiety or 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 anxiety or insomnia; for oral use for the treatment of anxiety or insomnia when sold in the manufacturer's original pack containing not more than 10 dosage units
Famciclovir; in divided solid dosage forms for oral use containing 500 milligrams or less for the treatment of recurrent herpes labialis when sold in the manufacturer's original pack containing up to 3 dosage units
Guaiphenesin; for oral use in modified release form with a maximum recommended daily dose of not more than 2.4 grams when sold in the manufacturer's original pack containing more than 10 days' supply but not more than 30 days' supply
Lansoprazole; in divided solid dosage forms for oral use containing 15 milligrams or less with a maximum daily dose of 15 milligrams for the short-term symptomatic relief of gastric reflux-like symptoms in sufferers aged 18 years and over or the relief of heartburn when sold in the manufacturer's original pack containing not more than 14 dosage units
Meclozine; in a pack size of up to 10 dosage units for the treatment of anxiety or 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 anxiety or insomnia; for oral use for the treatment of anxiety or insomnia when sold in the manufacturer's original pack containing not more than 10 dosage units
Miconazole; for the treatment of oral candidiasis; for vaginal use
Nystatin; for the treatment of oral candidiasis; for vaginal use
Pheniramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of anxiety or insomnia; for oral use for the treatment of anxiety or 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 anxiety or insomnia; for oral use for the treatment of anxiety or 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 anxiety or insomnia; for oral use for the treatment of anxiety or insomnia when sold in the manufacturer's original pack containing not more than 10 dosage units
Pharmacy-only Medicines
Amorolfine; in preparations for topical use except in preparations for the treatment of tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
Beclomethasone; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age in aqueous nasal sprays delivering up to 50 micrograms per actuation when the maximum recommended daily dose is no greater than 400 micrograms (200 micrograms per nostril) in a pack containing 200 actuations or less
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 50 micrograms per actuation and when the maximum recommended daily dose is no greater than 400 micrograms (200 micrograms per nostril) in a pack containing 200 actuations or less
Cetirizine; for oral use except in divided solid dosage forms for oral use containing 10 milligrams or less of cetirizine hydrochloride per dose form for the treatment of seasonal allergic rhinitis when sold in the manufacturer's original pack containing not more than 5 days' supply
Ciclopirox; for external use in medicines containing 2% or less except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
Clotrimazole; for external use except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
Diclofenac; in solid dose form in medicines containing 12.5 milligrams or less per dose form in packs containing not more than 30 tablets or capsules and with a recommended daily dose of not more than 75 milligrams
Econazole; for dermal use except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
Famotidine; 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
Fexofenadine; for oral use except for the treatment of seasonal allergic rhinitis when in capsules containing 60 milligrams or less of fexofenadine hydrochloride or in tablets containing 120 milligrams or less of fexofenadine hydrochloride with a maximum daily dose of 120 milligrams when sold in the manufacturer's original pack containing not more than 10 dosage units
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) in a pack containing 200 actuations or less
Ibuprofen; for oral use in liquid form with a recommended daily dose of not more than 1.2 grams for the relief of pain and reduction of fever or inflammation when sold in the manufacturer's original pack containing not more than 8 grams; for oral use in solid dose form containing not more than 200 milligrams per dose form and with a recommended daily dose of not more than 1.2 grams when sold in the manufacturer's original pack containing not more than 100 dose units; except in divided solid dosage forms for oral use containing 200 milligrams or less per dose form with a recommended daily dose of not more than 1.2 grams and when sold in the manufacturer's original pack containing not more than 25 dose units
Isoconazole; for dermal use except when sold in practice by a podiatrist registered with the Podiatrists Board
Ketoconazole; for dermal use except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board; except in medicines for treatment of the scalp containing 1% or less
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 5 days' supply
Mercurochrome; in preparations for external use containing 2% or less
Miconazole; for external use except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
Mometasone; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age in aqueous nasal sprays delivering up to 50 micrograms per actuation when the maximum recommended daily dose is no greater than 200 micrograms (as a single dose) in a pack containing 200 actuations or less
Nizatidine; 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
Nystatin; for dermal use except when sold in practice by a podiatrist registered with the Podiatrists Board
Omeprazole; 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 gastric reflux-like symptoms in sufferers aged 18 years and over when sold in the manufacturer's original pack containing not more than 28 dosage units
Pantoprazole; 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 gastric reflux-like symptoms in sufferers aged 18 years and over when sold in the manufacturer's original pack containing not more than 28 dosage units
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 150 milligrams or less per dose unit when sold in the manufacturer's original pack containing not more than 7 days' supply
Terbinafine; for dermal use except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
Tioconazole; for dermal use except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
Medicines for General Sale
Please note that the following medicines are now available for general sale.
Amorolfine; in preparations for the treatment of tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
C1 esterase inhibitors
Cetirizine; in divided solid dosage forms for oral use containing 10 milligrams or less of cetirizine hydrochloride per dose form for the treatment of seasonal allergic rhinitis when sold in the manufacturer's original pack containing not more than 5 days' supply
Ciclopirox; for external use in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
Clotrimazole; for external use in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
Diclofenac; in preparations for external use other than for the treatment of solar keratosis
Econazole; for dermal use in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
Factor VIII inhibitor bypassing fraction
Fexofenadine; for the treatment of seasonal allergic rhinitis in capsules containing 60 milligrams or less of fexofenadine hydrochloride or in tablets containing 120 milligrams or less of fexofenadine hydrochloride with a maximum daily dose of 120 milligrams when sold in the manufacturer's original pack containing not more than 10 dosage units
Guaiphenesin; for oral use in medicines containing 2% or less or 200 milligrams or less per dose form; for oral use in modified release form with a maximum recommended daily dose of not more than 2.4 grams when sold in the manufacturer's original pack containing not more than 10 days' supply
Human protein C
Ibuprofen; for external use; in divided solid dosage forms for oral use containing 200 milligrams or less per dose form with a recommended daily dose of not more than 1.2 grams and when sold in the manufacturer's original pack containing not more than 25 dose units per pack
Isoconazole; for dermal use when sold in practice by a podiatrist registered with the Podiatrists Board
Ketoconazole; for dermal use in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board; in medicines for treatment of the scalp containing 1% or less
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 5 days' supply
Miconazole; for external use in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
Nystatin; for dermal use when sold in practice by a podiatrist registered with the Podiatrists Board
Ranitidine; in medicines containing 150 milligrams or less per dose unit when sold in the manufacturer's original pack containing not more than 7 days' supply
Terbinafine; for dermal use in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
Tioconazole; for dermal use in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board