✨ Health Notices




394

NEW ZEALAND GAZETTE

No. 20

Health

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: Avelox

Active Ingredient(s): Moxifloxacin hydrochloride 436.8mg equivalent to 400mg moxifloxacin

Dosage Form: Film coated tablet

New Zealand Sponsor: Bayer New Zealand Limited Health Care Division

Manufacturer(s): Bayer AG, Leverkusen, Germany

Product: Crystacide

Active Ingredient(s): Hydrogen peroxide 1%w/w

Dosage Form: Topical cream

New Zealand Sponsor: AFT Pharmaceuticals Limited

Manufacturer(s): Bioglan AB, Malmo, Sweden

Product: Disodium Pamidronate Concentrated Injection

Active Ingredient(s): Pamidronic acid 2.53mg/mL equivalent to 3 mg/ml pamidronate disodium

Dosage Form: Concentrate for injection

New Zealand Sponsor: Baxter Healthcare Limited

Manufacturer(s): David Bull Laboratories Limited, Mulgrave North, Victoria, Australia

Product: Disodium Pamidronate Concentrated Injection

Active Ingredient(s): Pamidronic acid 5.05mg/mL equivalent to 6 mg/ml pamidronate disodium

Dosage Form: Concentrate for injection

New Zealand Sponsor: Baxter Healthcare Limited

Manufacturer(s): David Bull Laboratories Limited, Mulgrave North, Victoria, Australia

Product: Disodium Pamidronate Concentrated Injection

Active Ingredient(s): Pamidronic acid 7.58mg/mL equivalent to 9 mg/ml pamidronate disodium

Dosage Form: Concentrate for injection

New Zealand Sponsor: Baxter Healthcare Limited

Manufacturer(s): David Bull Laboratories Limited, Mulgrave North, Victoria, Australia

Product: Zometa

Active Ingredient(s): Zoledronic acid anhydrous 4mg

Dosage Form: Powder for infusion

New Zealand Sponsor: Novartis New Zealand Limited

Manufacturer(s): Novartis Pharma Stein AG/SA, Stein, Switzerland

Dated this 14th day of February 2001.

G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).

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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: AHF (High Purity) Dried Factor VIII Fraction

Active Ingredient(s): Factor VIII (human) 250IU

Dosage Form: Powder for injection

New Zealand Sponsor: CSL (New Zealand) Limited

Manufacturer(s): CSL Limited, Bioplasma Division, Broadmeadows, Victoria, Australia

Note: This consent is valid for 2 years from 25 February 2001.

Dated this 14th day of February 2001.

G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).

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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2001, No 20


Gazette.govt.nz PDF NZ Gazette 2001, No 20





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
14 February 2001
Medicines, Distribution, Avelox, Crystacide, Disodium Pamidronate, Zometa
  • G. R. Boyd, Chief Advisor, Safety and Regulation

πŸ₯ Renewal of Provisional Consent to the Distribution of a New Medicine

πŸ₯ Health & Social Welfare
14 February 2001
Medicines, Provisional Consent, AHF (High Purity) Dried Factor VIII Fraction
  • G. R. Boyd, Chief Advisor, Safety and Regulation