✨ 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:

  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 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 PDF NZ Gazette 2008, No 22


Gazette.govt.nz PDF NZ Gazette 2008, No 22





✨ LLM interpretation of page content

πŸ₯ Renewal of Provisional Consent to the Distribution of a New Medicine (continued from previous page)

πŸ₯ Health & Social Welfare
8 February 2008
Medicines Act 1981, Provisional Consent, New Medicine, Mitomycin-C-Kyowa
  • ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate

πŸ₯ Consent to the Distribution of a New Medicine

πŸ₯ Health & Social Welfare
8 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

πŸ₯ Classification of Medicines

πŸ₯ Health & Social Welfare
8 February 2008
Medicines Act 1981, Classification, Prescription Medicines, Restricted Medicines, Pharmacy-Only Medicines
  • ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate