✨ Medicine Consent and Classification
28 MARCH
NEW ZEALAND GAZETTE
789
Product:
NeutraGard (Mint flavour)
Active Ingredient:
Sodium fluoride 1.155%w/w
Dosage Form:
Oral topical gel
New Zealand Sponsor:
Ivoclar Vivadent Limited
Manufacturer:
Pascal Company Inc, Bellevue, Washington, United States of America
Product:
NeutraGard (Tropical Blast flavour)
Active Ingredient:
Sodium fluoride 1.155%w/w
Dosage Form:
Oral topical gel
New Zealand Sponsor:
Ivoclar Vivadent Limited
Manufacturer:
Pascal Company Inc, Bellevue, Washington, United States of America
Product:
Nicabate CQ Clear
Active Ingredient:
Nicotine 14mg/24h
Dosage Form:
Transdermal patch, systemic effect
New Zealand Sponsor:
SmithKline Beecham (NZ) Limited
Manufacturer:
Alza Corporation, Palo Alto, California, United States of America
Product:
Nicabate CQ Clear
Active Ingredient:
Nicotine 21mg/24h
Dosage Form:
Transdermal patch, systemic effect
New Zealand Sponsor:
SmithKline Beecham (NZ) Limited
Manufacturer:
Alza Corporation, Palo Alto, California, United States of America
Product:
Nicabate CQ Clear
Active Ingredient:
Nicotine 7mg/24h
Dosage Form:
Transdermal patch, systemic effect
New Zealand Sponsor:
SmithKline Beecham (NZ) Limited
Manufacturer:
Alza Corporation, Palo Alto, California, United States of America
Dated this 22nd day of March 2002.
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, Public Health Safety and
Regulation, acting under delegated authority, hereby declare
the following:
-
The medicines listed in Schedule 1 to this notice are
classified as prescription medicines. -
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
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 also applies:
(i) in the case of medicines which are injections or eye
preparations, to any concentration of that medicine;
(ii) in the case of medicines which are not injections or
eye preparations, when 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
Agalsidase
Atosiban
Bimatoprost
Dibotermin
Dutasteride
Eflornithine
Escitalopram
Etoricoxib
Factor VIII inhibitor bypassing fraction
Fondaparinux
Imatinib
Levocetirizine; except for oral use
Methyl aminolevulinate
Olopatadine
Parecoxib
Peginterferon
Pimecrolimus
Rasburicase
Rosuvastatin
Tadalafil
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Online Sources for this page:
VUW Te Waharoa —
NZ Gazette 2002, No 30
Gazette.govt.nz —
NZ Gazette 2002, No 30
✨ LLM interpretation of page content
🏥
Consent to the Distribution of New Medicines
(continued from previous page)
🏥 Health & Social Welfare22 March 2002
Medicines, Consent, NeutraGard, Nicabate CQ Clear, Sodium fluoride, Nicotine
- G. R. Boyd, Chief Advisor, Safety and Regulation
🏥 Classification of Medicines
🏥 Health & Social WelfareMedicines, Classification, Prescription medicines, Pharmacy-only medicines
- G. R. Boyd, Chief Advisor, Public Health Safety and Regulation