✨ Classification of Medicines




362 NEW ZEALAND GAZETTE, No. 16 17 FEBRUARY 2011

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

Benzocaine; except when specified elsewhere in this notice; except in dermal preparations containing 2% or less of total anaesthetic substances; except in lozenges containing 30 milligrams or less of total anaesthetic substances per dosage unit

Canakinumab

Certolizumab pegol

Clofarabine

Eltrombopag olamine

Fampridine

Flurbiprofen; except in locally acting oromucosal preparations containing 10 milligrams or less per preparation

Omeprazole; except when specified elsewhere in this notice

Schedule 3
Pharmacy-only Medicines

Benzocaine; in preparations for topical use, other than eye drops, containing 10% or less of total anaesthetic substances except in dermal preparations containing 2% or less of total anaesthetic substances; in divided preparations containing 200 milligrams or less of total anaesthetic substances per dosage unit except in lozenges containing 30 milligrams or less of total anaesthetic substances per dosage unit

Brompheniramine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with one or more other therapeutically active ingredients either when in the bed-time dose of a day/night pack containing brompheniramine or when at least one of the other active ingredients is a sympathomimetic decongestant

Chlorpheniramine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with one or more other therapeutically active ingredients either when in the bed-time dose of a day/night pack containing chlorpheniramine or when at least one of the other active ingredients is a sympathomimetic decongestant

Dexchlorpheniramine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with one or more other therapeutically active ingredients either when in the bed-time dose of a day/night pack containing dexchlorpheniramine or when at least one of the other active ingredients is a sympathomimetic decongestant

Diphenhydramine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with one or more other therapeutically active ingredients either when in the bed-time dose of a day/night pack containing diphenhydramine or when at least one of the other active ingredients is a sympathomimetic decongestant

Doxylamine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with one or more other therapeutically active ingredients either when in the bed-time dose of a day/night pack containing doxylamine or when at least one of the other active ingredients is a sympathomimetic decongestant

Flurbiprofen; in locally acting oromucosal preparations containing 10 milligrams or less per preparation

Omeprazole; in divided solid dosage forms for oral use containing 20 milligrams or less, with a maximum daily dose of 20 milligrams in a pack size of up to 14 dosage units, for the short-term symptomatic relief of gastric reflux-like symptoms in sufferers aged 18 years and over, when sold in a pack approved by the Minister or the Director-General for distribution as a pharmacy-only medicine

Pheniramine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with one or more other therapeutically active ingredients either when in the bed-time dose of a day/night pack containing pheniramine or when at least one of the other active ingredients is a sympathomimetic decongestant

Promethazine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with one or more other therapeutically active ingredients either when in the bed-time dose of a day/night pack containing promethazine or when at least one of the other active ingredients is a sympathomimetic decongestant

Trimeprazine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with one or more other therapeutically active ingredients either when in the bed-time dose of a day/night pack containing trimeprazine or when at least one of the other active ingredients is a sympathomimetic decongestant

Triprolidine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with one or more other therapeutically active ingredients either when in the bed-time dose of a day/night pack containing triprolidine or when at least one of the other active ingredients is a sympathomimetic decongestant

Medicines for General Sale

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

Benzocaine; in dermal preparations containing 2% or less of total anaesthetic substances; in lozenges containing 30 milligrams or less of total anaesthetic substances per dosage unit

Nicotine; in preparations for oromucosal or transdermal absorption

Dated this 8th day of February 2011.

BARBARA PHILLIPS, Acting Deputy Director-General,
Population Health Directorate, Ministry of Health.



Next Page →



Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2011, No 16





✨ LLM interpretation of page content

πŸ₯ Classification of Medicines (continued from previous page)

πŸ₯ Health & Social Welfare
8 February 2011
Medicines Act, Classification, Prescription medicines, Pharmacy-only medicines, General sale medicines
  • BARBARA PHILLIPS, Acting Deputy Director-General, Population Health Directorate, Ministry of Health