✨ Medicines and Health Notices
24 JUNE 2010 NEW ZEALAND GAZETTE, No. 70 2029
Medicines Act 1981
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: Biostate
Active Ingredients: Dried factor VIII fraction 500IU
von Willebrand’s factor : Ristocetin cofactor 1000IU
Dosage Form: Powder for injection
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturers: CSL Limited, Broadmeadows, Australia
Product: Biostate
Active Ingredients: Dried factor VIII fraction 1000IU
von Willebrand’s factor : Ristocetin cofactor 2000IU
Dosage Form: Powder for injection
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: CSL Limited, Broadmeadows, Australia
Product: Fentanyl Citrate
Active Ingredient: Fentanyl citrate 78.5μg/mL equivalent to fentanyl 50μg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Max Health Limited
Manufacturer: Macarthys Laboratories Limited t/a Martindale Pharmaceuticals, Essex, United Kingdom
Product: Victoza
Active Ingredient: Liraglutide 6mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Copenhagen, Denmark
Dated this 17th day of June 2010.
STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of 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 Medicine
Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicine set out in the Schedule hereto:
Schedule
Product: Luveris
Active Ingredient: Lutropin alfa, rch 75IU
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Laboratoires Serono SA, Aubonne, Switzerland
Note: This renewed consent is valid for two years from 30 October 2010.
Dated this 17th day of June 2010.
STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health
(pursuant to delegation given by the Minister of Health on 6 July 2001).
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New Zealand Public Health and Disability Act 2000
Appointment to the Northern X Regional Ethics Committee
Pursuant to section 11 of the New Zealand Public Health and Disability Act 2000, I appoint
Brian Fergus
as chair of the Northern X Regional Ethics Committee for a three-year term of office commencing on the date of this notification.
Dated at Wellington this 21st day of June 2010.
HON TONY RYALL, Minister of Health.
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✨ LLM interpretation of page content
🏥 Consent to the Distribution of New Medicines
🏥 Health & Social Welfare17 June 2010
Medicines Act 1981, New medicines, Distribution, Biostate, Fentanyl Citrate, Victoza
- STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health
🏥 Renewal of Provisional Consent to the Distribution of a Medicine
🏥 Health & Social Welfare17 June 2010
Medicines Act 1981, Provisional consent, Renewal, Luveris
- STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health
🏥 Appointment to the Northern X Regional Ethics Committee
🏥 Health & Social Welfare21 June 2010
New Zealand Public Health and Disability Act 2000, Appointment, Northern X Regional Ethics Committee
- Brian Fergus, Appointed chair of the Northern X Regional Ethics Committee
- HON TONY RYALL, Minister of Health
NZ Gazette 2010, No 70