✨ Medicines Classification




350 NEW ZEALAND GAZETTE, No. 16 15 FEBRUARY 2007

New Zealand Sponsor:
Novo Nordisk Pharmaceuticals Limited

Manufacturers:
Novo Nordisk A/S, Brennum Park, Hillerod, Denmark
Novo Nordisk A/S, Kalundborg, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Novo Nordisk Production S.A.S, Chartres Cedex, France

Product:
NovoRapid

Active Ingredient:
Insulin aspart 100U/mL

Dosage Form:
Solution for injection

New Zealand Sponsor:
Novo Nordisk Pharmaceuticals Limited

Manufacturers:
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Novo Nordisk Pharmaceutical Industries, Inc., Clayton, North Carolina, United States of America

Dated this 9th day of February 2007.

DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Classification of Medicines

Pursuant to section 106(1) of the Medicines Act 1981,
I, Graeme Gillespie, Acting 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 or the concentration of the total active principles 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
Amphotericin
Anagrelide
Azatadine; except when specified elsewhere in this Schedule
Brompheniramine; except when specified elsewhere in this Schedule
Brugmansia spp
Chlorpheniramine; except when specified elsewhere in this Schedule
Dexchlorpheniramine; except when specified elsewhere in this Schedule

Dimenhydrinate; except when specified elsewhere in this Schedule
Diphenhydramine; except when specified elsewhere in this Schedule
Diphenylpyraline; except when specified elsewhere in this Schedule
Doxylamine; except when specified elsewhere in this Schedule
Exenatide
Mepyramine; except when specified elsewhere in this Schedule
Oseltamivir; except when sold by a registered pharmacist between the months of May to September inclusive for the treatment of seasonal influenza to a consumer 12 years of age or more presenting in a pharmacy with early symptoms of influenza
Paracetamol; except when specified elsewhere in this Schedule
Phenyltoloxamine
Promethazine; except when specified elsewhere in this Schedule
Sitagliptin
Sorafenib
Sumatriptan; except when specified elsewhere in this Schedule
Sunitinib
Telbivudine
Thenyldiamine
Trimeprazine; except when specified elsewhere in this Schedule
Triprolidine; except when specified elsewhere in this Schedule
Varenicline

Schedule 2

Restricted Medicines
Azatadine; for oral use in adults and children over 2 years of age
Brompheniramine; for oral use medicines for adults and children over 2 years of age except when specified elsewhere in this Schedule
Chlorpheniramine; for oral use in medicines for adults and children over 2 years of age except when specified elsewhere in this Schedule
Dexchlorpheniramine; for oral use in medicines for adults and children over 2 years of age except when specified elsewhere in this Schedule



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2007, No 16


Gazette.govt.nz PDF NZ Gazette 2007, No 16





✨ LLM interpretation of page content

πŸ₯ Consent to Distribution of NovoRapid

πŸ₯ Health & Social Welfare
9 February 2007
Medicines, Distribution, Consent, NovoRapid
  • DON MATHESON, Deputy Director-General, Public Health

πŸ₯ Classification of Medicines

πŸ₯ Health & Social Welfare
Medicines, Classification, Prescription, Restricted, Pharmacy-only
  • Graeme Gillespie, Acting Deputy Director-General, Public Health Directorate