✨ Medicines Act Notices




11 AUGUST 2005

NEW ZEALAND GAZETTE, No. 123

3011

Medicines Act 1981

Consent to the Distribution of a Changed Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicine which was referred to the Minister of Health under the provisions of section 24 (5) of the Act and is set out in the Schedule hereto:

Schedule

Product:
Poliomyelitis Vaccine (Oral) Sabin Strain

Active Ingredients:
Polio virus type 1 1,000,000CCID50
Polio virus type 2 100,000CCID50
Polio virus type 3 316,227CCID50

Dosage Form:
Oral suspension

New Zealand Sponsor:
GlaxoSmithKline (NZ) Limited

Manufacturer:
GlaxoSmithKline Biologicals SA, Rixensart, Belgium

Dated this 5th day of August 2005.

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

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Renewal of Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23 of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:

Schedule

Product:
Thalidomide Pharmion

Active Ingredient:
Thalidomide 50mg

Dosage Form:
Capsule

New Zealand Sponsor:
Douglas Pharmaceuticals Limited

Manufacturer:
Penn Pharmaceuticals Limited, Tredegar, Gwent, United Kingdom

Note: This consent is given subject to the following conditions:

  • Only members of the Royal Australasian College of Physicians can prescribe Thalidomide.
  • Douglas Pharmaceuticals Limited will manage the risk management programme relating to the distribution and use of thalidomide.

Note: This consent is valid for two years from 18 December 2005.

Dated this 5th day of August 2005.

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

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Consent to the Distribution of New Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:

Schedule

Product:
Jadelle

Active Ingredient:
Levonorgestrel 75mg

Dosage Form:
Subcutaneous implant

New Zealand Sponsor:
Schering (NZ) Limited

Manufacturer:
Schering Oy, Turku 10, Finland

Product:
Nicotinell (Fruit flavoured)

Active Ingredient:
Nicotine 2mg

Dosage Form:
Chewing gum

New Zealand Sponsor:
Novartis New Zealand Limited Pharmaceutical Sector

Manufacturer:
Fertin Pharma A/S, Vejle, Denmark

Product:
Nicotinell (Fruit flavoured)

Active Ingredient:
Nicotine 4mg

Dosage Form:
Chewing gum

New Zealand Sponsor:
Novartis New Zealand Limited Pharmaceutical Sector

Manufacturer:
Fertin Pharma A/S, Vejle, Denmark

Product:
Nicotinell (Liquorice flavoured)

Active Ingredient:
Nicotine 2mg

Dosage Form:
Chewing gum

New Zealand Sponsor:
Novartis New Zealand Limited Pharmaceutical Sector

Manufacturer:
Fertin Pharma A/S, Vejle, Denmark



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2005, No 123


Gazette.govt.nz PDF NZ Gazette 2005, No 123





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of a Changed Medicine

πŸ₯ Health & Social Welfare
5 August 2005
Medicines Act, Poliomyelitis Vaccine, Distribution Consent, Health Regulations
  • DON MATHESON, Deputy Director-General, Public Health

πŸ₯ Renewal of Provisional Consent to the Distribution of a New Medicine

πŸ₯ Health & Social Welfare
5 August 2005
Medicines Act, Thalidomide, Provisional Consent, Health Regulations
  • DON MATHESON, Deputy Director-General, Public Health

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
5 August 2005
Medicines Act, Jadelle, Nicotinell, Distribution Consent, Health Regulations
  • DON MATHESON, Deputy Director-General, Public Health