Pursuant to section 106 (1) of the Medicines Act 1981,
I, Don Matheson, Deputy Director General, Public Health Directorate, 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:
(a) preparations and admixtures containing any proportion of any substance listed in the notice.
(b) salts and esters of any substance listed in the notice.
(c) preparations or extracts of biological materials listed in the notice.
(d) salts or oxides of elements listed in the notice.
Unless specific reference is made otherwise, every reference to a medicine applies:
(i) if the medicine is in an injection or eye preparation, to any concentration of that medicine; and
(ii) 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
Acrivastine
Alclometasone; except when specified elsewhere in the Schedule
Alemtuzumab
Anecortave
Antazoline; except for ophthalmic use
Azatadine; except for oral use
Bamipine
Bethanechol
Brompheniramine; except when specified elsewhere in the Schedule
Buclizine; except for oral use
Butoconazole
Carbuterol
Chlorcyclizine
Chlorpheniramine; except when specified elsewhere in the Schedule
Clemastine; except for oral use
Clemizole
Clobetasone; except when specified elsewhere in the Schedule
Cyclizine; except for oral use
Cyproheptadine; except for oral use
Dexchlorpheniramine; when specified elsewhere in the Schedule
Dibromopropamidine; except for ophthalmic use
Dichlorophen
Dimenhydrinate; except when specified elsewhere in the Schedule
Dimethindene; except for oral use
Dimethothiazine
Diphenhydramine; except when specified elsewhere in the Schedule
Diphenylpyraline; except when specified elsewhere in the Schedule
Doxylamine; except when specified elsewhere in the Schedule
Entecavir
Erlotinib
Ethyl chloride; for inhalation
Flunisolide
Fosamprenavir
Hexoprenaline
Hydrargaphen
Juniperus sabina; at all strengths
Mebhydrolin
Meclozine; except when specified elsewhere in the Schedule
Melia azedarach; at all strengths
Mepyramine; except for dermal use
Mequitazine
Mercury; except when specified elsewhere in the Schedule; except in medicines containing 1 milligram or less per litre or per kilogram
Methdilazine; except for oral use
Muraglitazar
Nesiritide
Nux vomica; except in medicines containing 1 milligram or less per litre or per kilogram of strychnine
Orlistat; except when specified elsewhere in the Schedule
Pegaptanib
Pentaerithrityl tetranitrate
Phenazopyridine
Pheniramine; except when specified elsewhere in the Schedule
Phenyltoloxamine; except for oral use
Posaconazole
Promethazine; except when specified elsewhere in the Schedule
Propamidine; except for ophthalmic use
Solifenacin
Thenyldiamine; except when specified elsewhere in the Schedule
Trimeprazine; except when specified elsewhere in the Schedule
Triprolidine; except when specified elsewhere in the Schedule
Schedule 2
Restricted Medicines
Alclometasone; for dermal use in medicines containing 0.05% or less and in packs containing not more than
30 grams which have received the consent of the Minister or the Director-General to their distribution as restricted medicines and are sold in the manufacturer’s original pack
Azatadine; for oral use
Brompheniramine; for oral use except when specified elsewhere in the Schedule
Buclizine; for oral use
Chlorpheniramine; for oral use except when specified elsewhere in the Schedule
Clemastine; for oral use
Clobetasone; for dermal use in medicines containing 0.05% or less and in packs containing not more than 30 grams which have received the consent of the Minister or
the Director-General to their distribution as restricted medicines and are sold in the manufacturer’s original pack
Cyclizine; for oral use
Cyproheptadine; for oral use
Dexchlorpheniramine; for oral use except when specified elsewhere in the Schedule
Dimenhydrinate; for oral use except when specified elsewhere in the Schedule
Dimethindene; for oral use
Diphenhydramine; for oral use except when specified elsewhere in the Schedule
Diphenylpyraline; for oral use except when specified elsewhere in the Schedule
Doxylamine; for oral use except when specified elsewhere in the Schedule
Methdilazine; for oral use
Orlistat; in medicines containing 120 milligrams or less per dose form for the purpose of weight control
Pheniramine; for oral use except when specified elsewhere in the Schedule
Phenyltoloxamine; for oral use
Promethazine; for oral use except when specified elsewhere in the Schedule
Stramonium; for oral use in liquid form; in solid dose form in medicines containing more than 0.3 milligrams per dose or more than 1.2 milligrams per recommended daily dose
Thenyldiamine; for oral use in solid dose form or in liquid form containing 10 milligrams or less of thenyldiamine per 5 millilitres except when specified elsewhere in the Schedule
Trimeprazine; for oral use in solid dose form or in liquid form containing 10 milligrams or less per 5 millilitres; except when specified elsewhere in the Schedule
Triprolidine; for oral use except when specified elsewhere in the Schedule
Schedule 3
Pharmacy-only Medicines
Aciclovir; for external use for the treatment of herpes labialis except in medicines containing 5% or less and
in tubes containing 10 grams or less
Antazoline; for ophthalmic use
Benzocaine; in mouthwashes containing 10% or less; for external use in medicines other than mouthwashes containing 10% or less and more than 2% except in throat lozenges containing 30 milligrams or less per dose form
Brompheniramine; for oral use when combined with one or more other therapeutically active substances for the treatment of coughs, colds or influenza when at least
one of the other therapeutically active substances is a sympathomimetic decongestant or in a day/night pack containing brompheniramine in the bedtime dose and in preparations for adults or children two years of age or more
Chlorpheniramine; for oral use when combined with one or more other therapeutically active substances for the treatment of coughs, colds or influenza when at least
one of the other therapeutically active substances is a sympathomimetic decongestant or in a day/night pack containing chlorpheniramine in the bedtime dose and in preparations for adults or children two years of age or more
Dexchlorpheniramine; for oral use when combined with one or more other therapeutically active substances for the treatment of coughs, colds or influenza when at least
one of the other therapeutically active substances is a sympathomimetic decongestant or in a day/night pack containing dexchlorpheniramine in the bedtime dose and in preparations for adults or children two years of age or more
Dibrompropamidine; for ophthalmic use
Dimenhydrinate; for oral use in a sealed container of not more than 10 tablets or capsules for the prevention or treatment of motion sickness except when sold at a transport terminal or aboard a ship or plane
Diphenhydramine; for oral use when combined with one or more other therapeutically active substances for the treatment of coughs, colds or influenza when at least
one of the other therapeutically active substances is a sympathomimetic decongestant or in a day/night pack containing diphenhydramine in the bedtime dose and
in preparations for adults or children two years of
age or more; in a sealed container of not more than
10 tablets or capsules of diphenhydramine theoclate for the prevention or treatment of motion sickness except when sold at a transport terminal or aboard a ship or plane
Diphenylpyraline; for oral use when combined with one or more other therapeutically active substances for the treatment of coughs, colds or influenza when at least
one of the other therapeutically active substances is a sympathomimetic decongestant or in a day/night pack containing diphenylpyraline in the bedtime dose and in preparations for adults or children two years of age or more
Doxylamine; for oral use when combined with one or
more other therapeutically active substances for the treatment of coughs, colds or influenza when at least
one of the other therapeutically active substances is a sympathomimetic decongestant or in a day/night pack containing doxylamine in the bedtime dose and in preparations for adults or children two years of age or more
Meclozine; in a sealed container of not more than 12 tablets or capsules for the prevention of travel sickness except when sold at a transport terminal or aboard a ship or plane
Mepyramine; for dermal use
Naphazoline
Pheniramine; for ophthalmic use; for oral use when combined with one or more other therapeutically active substances for the treatment of coughs, colds or influenza when at least one of the other therapeutically active substances is a sympathomimetic decongestant
or in a day/night pack containing pheniramine in the bedtime dose and in preparations for adults or children two years of age or more
Promethazine; for oral use when combined with one or
more other therapeutically active substances for the treatment of coughs, colds or influenza when at least
one of the other therapeutically active substances is a sympathomimetic decongestant or in a day/night pack containing promethazine in the bedtime dose and in preparations for adults or children two years of
age or more; in a sealed container of not more than
10 tablets or capsules for the prevention or treatment of motion sickness except when sold at a transport terminal or aboard a ship or plane
Propamidine; for ophthalmic use
Stramonium; in solid dose form in medicines containing 0.3 milligrams or less per dose and 1.2 milligrams or less per recommended daily dose
Thenyldiamine; for nasal use; for oral use when combined with one or more other therapeutically active substances for the treatment of coughs, colds or influenza when at least one of the other therapeutically active substances is a sympathomimetic decongestant or in a day/night pack containing thenyldiamine in the bedtime dose and in preparations for adults or children two years of age or more
Trimeprazine; for oral use when combined with one or
more other therapeutically active substances for the treatment of coughs, colds or influenza when at least
one of the other therapeutically active substances is a sympathomimetic decongestant or in a day/night pack containing trimeprazine in the bedtime dose and in preparations for adults or children two years of age or more
Triprolidine; for oral use when combined with one or
more other therapeutically active substances for the treatment of coughs, colds or influenza when at least
one of the other therapeutically active substances is a sympathomimetic decongestant or in a day/night pack containing triprolidine in the bedtime dose and in preparations for adults or children two years of age or more
Medicines for General Sale
Please note that the following medicines are no longer classified as prescription medicines, restricted medicines or pharmacy-only medicines. As such, they are now available for general sale.
Aciclovir; for external use for the treatment of herpes labialis in medicines containing 5% or less and in tubes containing 10 grams or less
Acriflavin
Pomegranate
Dated this 30th day of August 2005.
DON MATHESON, Deputy Director-General, Public Health Directorate.