β¨ 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 —
NZ Gazette 2005, No 123
Gazette.govt.nz —
NZ Gazette 2005, No 123
β¨ LLM interpretation of page content
π₯ Consent to the Distribution of a Changed Medicine
π₯ Health & Social Welfare5 August 2005
Medicines Act, Poliomyelitis Vaccine, Distribution Consent, Health Regulations
- DON MATHESON, Deputy Director-General, Public Health
π₯ Renewal of Provisional Consent to the Distribution of a New Medicine
π₯ Health & Social Welfare5 August 2005
Medicines Act, Thalidomide, Provisional Consent, Health Regulations
- DON MATHESON, Deputy Director-General, Public Health
π₯ Consent to the Distribution of New Medicines
π₯ Health & Social Welfare5 August 2005
Medicines Act, Jadelle, Nicotinell, Distribution Consent, Health Regulations
- DON MATHESON, Deputy Director-General, Public Health