β¨ Medicines Notices
14 FEBRUARY 2008
NEW ZEALAND GAZETTE, No. 22
503
Schedule
Product:
Mitomycin-C-Kyowa
Active Ingredient:
Mitomycin 10mg
Dosage Form:
Powder for injection
New Zealand Sponsor:
Bristol-Myers Squibb (NZ) Limited
Manufacturer:
Kyowa Hakko Kogyo Co Limited, Chiyoda-Ku, Tokyo, Japan
Note: This consent is valid for two years from the date of publication of this notice.
Product:
Mitomycin-C-Kyowa
Active Ingredient:
Mitomycin 2mg
Dosage Form:
Powder for injection
New Zealand Sponsor:
Bristol-Myers Squibb (NZ) Limited
Manufacturer:
Kyowa Hakko Kogyo Co Limited, Chiyoda-Ku, Tokyo, Japan
Note: This consent is valid for two years from the date of publication of this notice.
Product:
Mitomycin-C-Kyowa
Active Ingredient:
Mitomycin 20mg
Dosage Form:
Powder for injection
New Zealand Sponsor:
Bristol-Myers Squibb (NZ) Limited
Manufacturer:
Kyowa Hakko Kogyo Co Limited, Chiyoda-Ku, Tokyo, Japan
Note: This consent is valid for two years from the date of publication of this notice.
Dated this 8th day of February 2008.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).
go941
Consent to the Distribution of a New Medicine
Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the Schedule hereto:
Schedule
Product:
Metamucil Wild Berry Smooth Psyllium Husk Powder Fibre Supplement
Active Ingredient:
Ispaghula husk 568mg/g
Dosage Form:
Powder for oral solution
New Zealand Sponsor:
Procter & Gamble Distributing New Zealand
Manufacturer:
Procter & Gamble Manufacturing Co, Phoenix, Arizona, United States of America
Dated this 8th day of February 2008.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).
go942
Classification of Medicines
Pursuant to section 106(1) of the Medicines Act 1981,
I, Anthony Hill, Deputy Director-General, Sector Accountability and Funding Directorate, 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 2 to this notice are classified as restricted 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 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
Abatacept
Aliskiren
Amphotericin
Amyl nitrite; except when sold from outlets licensed to sell cyanide paste for the purpose of vertebrate pest control
Anagrelide
Azacitidine
Azatadine; except when specified elsewhere in this Schedule
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Online Sources for this page:
VUW Te Waharoa —
NZ Gazette 2008, No 22
Gazette.govt.nz —
NZ Gazette 2008, No 22
β¨ LLM interpretation of page content
π₯
Renewal of Provisional Consent to the Distribution of a New Medicine
(continued from previous page)
π₯ Health & Social Welfare8 February 2008
Medicines Act 1981, Provisional Consent, New Medicine, Mitomycin-C-Kyowa
- ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate
π₯ Consent to the Distribution of a New Medicine
π₯ Health & Social Welfare8 February 2008
Medicines Act 1981, Consent, New Medicine, Metamucil Wild Berry Smooth Psyllium Husk Powder Fibre Supplement
- ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate
π₯ Classification of Medicines
π₯ Health & Social Welfare8 February 2008
Medicines Act 1981, Classification, Prescription Medicines, Restricted Medicines, Pharmacy-Only Medicines
- ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate