β¨ Medicines Notices
8 NOVEMBER
NEW ZEALAND GAZETTE
3783
Product:
CAPD/DPCA 12 Sleep Safe
Active Ingredient(s):
Calcium chloride (dihydrate) 0.147g/L
Glucose monohydrate 25g/L equivalent glucose anhydrous 22.73g/L
Magnesium chloride (hexahydrate) 0.1017g/L
Sodium chloride 5.786g/L
Sodium lactate 3.925g/L
Dosage Form:
Dialysis solution
New Zealand Sponsor:
Fresenius Medical Care New Zealand
Manufacturer(s):
Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Product:
CAPD/DPCA 2 Sleep Safe
Active Ingredient(s):
Calcium chloride (dihydrate) 0.2573g/L
Glucose monohydrate 16.5g/L equivalent glucose anhydrous 15g/L
Magnesium chloride (hexahydrate) 0.1017g/L
Sodium chloride 5.786g/L
Sodium lactate 3.925g/L
Dosage Form:
Dialysis solution
New Zealand Sponsor:
Fresenius Medical Care New Zealand
Manufacturer(s):
Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Product:
CAPD/DPCA 3 Sleep Safe
Active Ingredient(s):
Calcium chloride (dihydrate) 0.2573g/L
Glucose monohydrate 46.75g/L equivalent to glucose anhydrous 42.5g/L
Magnesium chloride (hexahydrate) 0.1017g/L
Sodium chloride 5.786g/L
Sodium lactate 3.925g/L
Dosage Form:
Dialysis solution
New Zealand Sponsor:
Fresenius Medical Care New Zealand
Manufacturer(s):
Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Product:
CAPD/DPCA 4 Sleep Safe
Active Ingredient(s):
Calcium chloride (dihydrate) 0.2573g/L
Glucose monohydrate 25g/L equivalent glucose anhydrous 22.73g/L
Magnesium chloride (hexahydrate) 0.1017g/L
Sodium chloride 5.786g/L
Sodium lactate 3.925g/L
Dosage Form:
Dialysis solution
New Zealand Sponsor:
Fresenius Medical Care New Zealand
Manufacturer(s):
Fresenius Medical Care Deutschland GmbH, St Wendel, Saarland, Germany
Product:
Somatuline LA
Active Ingredient(s):
Lanreotide 30mg
Dosage Form:
Powder for injection
New Zealand Sponsor:
New Zealand Medical & Scientific Ltd
Manufacturer(s):
Pharma Biotech, Signes, France
Dated this 31st day of October 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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Consent to the Distribution of a Changed Medicine
Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicine which was referred to the Minister of Health under the provisions of section 24 (5) of the Act and is set out in the Schedule hereto:
Schedule
Product:
Visudyne
Active Ingredient(s):
Verteporfin 15mg
Dosage Form:
Powder for infusion
New Zealand Sponsor:
Novartis New Zealand Limited
Manufacturer(s):
Parkedale Pharmaceuticals Inc, Rochester, Michigan, United States of America
Dated this 31st day of October 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 153
Gazette.govt.nz —
NZ Gazette 2001, No 153
β¨ LLM interpretation of page content
π₯
Consent to the Distribution of New Medicines
(continued from previous page)
π₯ Health & Social Welfare31 October 2001
Medicines Act 1981, Consent, CAPD/DPCA 12 Sleep Safe, CAPD/DPCA 2 Sleep Safe, CAPD/DPCA 3 Sleep Safe, CAPD/DPCA 4 Sleep Safe, Somatuline LA, Fresenius Medical Care New Zealand
- G. R. Boyd, Chief Advisor, Safety and Regulation
π₯ Consent to the Distribution of a Changed Medicine
π₯ Health & Social Welfare31 October 2001
Medicines Act 1981, Consent, Visudyne, Novartis New Zealand Limited
- G. R. Boyd, Chief Advisor, Safety and Regulation