✨ 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 PDF NZ Gazette 2001, No 153


Gazette.govt.nz PDF NZ Gazette 2001, No 153





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines (continued from previous page)

πŸ₯ Health & Social Welfare
31 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

πŸ₯ Consent to the Distribution of a Changed Medicine

πŸ₯ Health & Social Welfare
31 October 2001
Medicines Act 1981, Consent, Visudyne, Novartis New Zealand Limited
  • G. R. Boyd, Chief Advisor, Safety and Regulation