β¨ 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 —
NZ Gazette 2001, No 20
Gazette.govt.nz —
NZ Gazette 2001, No 20
β¨ LLM interpretation of page content
π₯ Consent to the Distribution of New Medicines
π₯ Health & Social Welfare14 February 2001
Medicines, Distribution, Avelox, Crystacide, Disodium Pamidronate, Zometa
- G. R. Boyd, Chief Advisor, Safety and Regulation
π₯ Renewal of Provisional Consent to the Distribution of a New Medicine
π₯ Health & Social Welfare14 February 2001
Medicines, Provisional Consent, AHF (High Purity) Dried Factor VIII Fraction
- G. R. Boyd, Chief Advisor, Safety and Regulation