✨ Medicines Act Notices




4300 NEW ZEALAND GAZETTE, No. 164 30 OCTOBER 2008

are authorised tissue banks for the purposes of section 86 of the Human Tissue Act 2008.

Dated at Wellington this 15th day of October 2008.

ANDREW BRIDGMAN, Director-General of Health
(Acting).

go7978


Medicines Act 1981

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
Diluent
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 the date of publication of this notice.

Dated this 23rd day of October 2008.

JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).

go8116

Consent to the Distribution of a New Medicine

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: Apo-Gabapentin
Active Ingredient: Gabapentin 100mg equivalent to 97.09% w/w
Dosage Form: Capsule
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Etobicoke, Ontario, Canada

Product: Arrow-Simva 10
Active Ingredient: Simvastatin 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Micro Labs Limited, Hosur, Tamil Nadur, India

Product: Arrow-Simva 20
Active Ingredient: Simvastatin 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Micro Labs Limited, Hosur, Tamil Nadur, India

Product: Arrow-Simva 40
Active Ingredient: Simvastatin 40mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Micro Labs Limited, Hosur, Tamil Nadur, India

Product: Arrow-Simva 80
Active Ingredient: Simvastatin 80mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Micro Labs Limited, Hosur, Tamil Nadur, India

Product: Galvus
Active Ingredient: Vildagliptin 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland



Next Page →



Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2008, No 164





✨ LLM interpretation of page content

πŸ₯ Authorisation of Tissue Banks

πŸ₯ Health & Social Welfare
15 October 2008
Human Tissue Act 2008, Tissue Banks, Authorisation
  • ANDREW BRIDGMAN, Director-General of Health (Acting)

πŸ₯ Renewal of Provisional Consent for Medicine Distribution

πŸ₯ Health & Social Welfare
23 October 2008
Medicines Act 1981, Provisional Consent, Luveris, Lutropin alfa
  • JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate

πŸ₯ Consent to Distribution of New Medicines

πŸ₯ Health & Social Welfare
23 October 2008
Medicines Act 1981, New Medicines, Apo-Gabapentin, Arrow-Simva, Galvus
  • JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate