4406 NEW ZEALAND GAZETTE, No. 175 13 OCTOBER 2005

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: Copaxone
Active Ingredient: Glatiramer acetate 20mg
Dosage Form: Solution for injection
New Zealand Sponsor: Aventis Pharma Limited
Manufacturers: Baxter Pharmaceutical Solutions LLC, Bloomington, Indiana, United States of America
Teva Pharmaceutical Industries Limited, Industrial Zone, (Ikapharm) Kfar Saba, Israel

Note: This consent is valid for two years from the date of this publication.

Dated this 10th day of October 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: Iressa
Active Ingredient: Gefitinib 250mg
Dosage Form: Coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca UK Limited, Macclesfield, Cheshire, United Kingdom

Note: This consent is valid for two years from 22 January 2006.

Dated this 10th day of October 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 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: Priorix
Active Ingredients: Measles vaccine, Schwarz strain 1,000CCID50
Mumps virus, live attenuated, RIT 4385 5,012CCID50
Rubella virus, Wistar RA27/3 strain 1,000CCID50
Dosage Form: Lyophilized powder in vial powder for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: GlaxoSmithKline Biologicals SA, Rixensart, Belgium
GlaxoSmithKline Biologicals SA, Genval, Belgium
Sachsisches Serumwerk Dresden, Branch of SKB Pharma GmbH, Dresden, Germany

Dated this 10th day of October 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 a New Related Product

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

Schedule

Product: Neutrogena Oil Free Acne Wash Cream Cleanser
Active Ingredient: Salicylic acid 2%w/w
Dosage Form: Topical cream
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Neutrogena Corporation, Los Angeles, California, United States of America

Dated this 10th day of October 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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