β¨ Medicines Act Notices
3376 NEW ZEALAND GAZETTE, No. 130 29 NOVEMBER 2007
Medicines Act 1981
Consent to the Distribution of Changed Medicines
Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicines which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
Product: 3TC
Active Ingredient: Lamivudine 150mg
Dosage Form: White film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Glaxo Operations UK Limited (t/a Glaxo Wellcome Operations), Ware, Hertfordshire, United Kingdom
Product: Combivir
Active Ingredients: Lamivudine 150mg
Zidovudine 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: Glaxo Operations UK Limited (t/a Glaxo Wellcome Operations), Ware, Hertfordshire, United Kingdom
GlaxoSmithKline Australia Pty Limited, Boronia, Victoria, Australia
Dated this 23rd day of November 2007.
JULIE PATTERSON, Acting Deputy Director-General, Sector Accountability and Funding Directorate (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: Rapamune
Active Ingredient: Sirolimus 1mg
Dosage Form: Tablet
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturers: Wyeth Pharmaceuticals Company, Barrios Pozo Hondos & Jobos, Guayama, Puerto Rico
Wyeth Pharmaceuticals Inc, Rouses Point, New York, United States of America
Note: This consent is valid for two years from 22 November 2007.
Product: Rapamune
Active Ingredient: Sirolimus 2mg
Dosage Form: Coated tablet
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturers: Wyeth Pharmaceuticals Company, Barrios Pozo Hondos & Jobos, Guayama, Puerto Rico
Wyeth Pharmaceuticals Inc, Rouses Point, New York, United States of America
Note: This consent is valid for two years from 12 January 2008.
Dated this 23rd day of November 2007.
JULIE PATTERSON, Acting Deputy Director-General, Sector Accountability and Funding Directorate (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: Ciloxan Eye Ointment
Active Ingredient: Ciprofloxacin hydrochloride 3.5mg/g equivalent to anhydrous ciprofloxacin base 3mg/g
Dosage Form: Eye ointment
New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturer: SA Alcon Couvreur NV, Puurs, Belgium
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Online Sources for this page:
VUW Te Waharoa —
NZ Gazette 2007, No 130
Gazette.govt.nz —
NZ Gazette 2007, No 130
β¨ LLM interpretation of page content
π₯ Consent to the Distribution of Changed Medicines
π₯ Health & Social Welfare23 November 2007
Medicines, Distribution, Consent, Lamivudine, Zidovudine, GlaxoSmithKline
- JULIE PATTERSON, Acting Deputy Director-General, Sector Accountability and Funding Directorate
π₯ Renewal of Provisional Consent to the Distribution of a New Medicine
π₯ Health & Social Welfare23 November 2007
Medicines, Provisional Consent, Renewal, Sirolimus, Rapamune, Wyeth
- JULIE PATTERSON, Acting Deputy Director-General, Sector Accountability and Funding Directorate
π₯ Consent to the Distribution of New Medicines
π₯ Health & Social Welfare23 November 2007
Medicines, Distribution, Consent, Ciprofloxacin, Ciloxan, Pacific Pharmaceuticals
- JULIE PATTERSON, Acting Deputy Director-General, Sector Accountability and Funding Directorate