✨ Medicines Classification and Approval




NEW ZEALAND GAZETTE

No. 39

Manufacturer(s):
Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Schering-Plough Products Inc, Las Piedras, Puerto Rico

New Zealand Sponsor:
Schering-Plough Pty Limited

Product:
Sinus & Nasal Decongestant

Active Ingredient(s):
Pseudoephedrine hydrochloride 60mg

Dosage Form:
Tablet

New Zealand Sponsor:
PSM Healthcare Limited

Manufacturer(s):
PSM Healthcare Limited, Wiri, Auckland

Dated this 7th day of April 2000.

G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).

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Classification of Medicines

Pursuant to section 106 (1) of the Medicines Act 1981, I, G. R. Boyd, Chief Advisor, Safety and Regulation, 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.

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

acetanilides
acetylmethyldimethoxyimidophenylhydrazine
acokanthera
adonis
adrenaline; in medicines containing more than 1%
aldesleukin
ambenonium
amfebutamone
ammi visnaga
amyl nitrite; except when sold from outlets licensed under the Toxic Substances Regulations 1983 to sell sodium cyanide paste for the purpose of vertebrate pest control
ancestim
antithrombin III
apocynum
apovirdine
azelastine; for ophthalmic use
bambuterol
becaplermin
benzoyl metronidazole
bivalirudin
bufexamac; except in suppositories or medicines for dermal use containing 5% or less
bupropion
butyl nitrite
calotropis
camphorated oil
camphotamide
capecitabine
celecoxib
cetirizine; except for oral use
cetrorelix
cholera vaccine
cidofovir
clenbuterol
clioquinol
clorprenaline
convallaria
coronilla
cymarin
cysteamine
dalfopristin
debrisoquine
delavirdine
demecarium
diethazine
dihydralazine
di-iodohydroxyquinoline; except for vaginal use
dipivefrin
diphemanil; except for dermal use
dofetilide
efavirenz
eleriptan
entacapone
eptifibatide
erysimum
ethopropazine
etilefrine
felypressin
fencamfamin
fenpropex
fexofenadine; except for oral use
fluticasone; except when specified elsewhere in the Schedule
fosfestrol
fosphenytoin
galanthus



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2000, No 39


Gazette.govt.nz PDF NZ Gazette 2000, No 39





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
7 April 2000
Medicines Act 1981, New Medicines, Sinus & Nasal Decongestant, Pseudoephedrine hydrochloride
  • G. R. Boyd, Chief Advisor, Safety and Regulation

πŸ₯ Classification of Medicines

πŸ₯ Health & Social Welfare
Medicines Act 1981, Prescription Medicines, Restricted Medicines, Pharmacy-Only Medicines, Classification
  • G. R. Boyd, Chief Advisor, Safety and Regulation