✨ Medicines Consent Notices




NEW ZEALAND GAZETTE, No. 90 β€” 7 SEPTEMBER 2017

Product:
Dianeal 1mmol/L Calcium Peritoneal Dialysis Solution

Active Ingredients:

  • Calcium chloride dihydrate 0.1455g/L
  • Glucose monohydrate 24.75g/L
  • Magnesium chloride hexahydrate 0.0503g/L
  • Sodium chloride 5.33g/L
  • Sodium lactate 7.4g/L

Dosage Form:
Dialysis solution

New Zealand Sponsor:
Baxter Healthcare Limited

Manufacturer:
Baxter Healthcare Pty Limited, Sydney, Australia

Note: This renewed consent is valid for two years from 12 September 2017.

Product:
Dianeal 1mmol/L Calcium Peritoneal Dialysis Solution

Active Ingredients:

  • Calcium chloride dihydrate 0.1455g/L
  • Glucose monohydrate 42.08g/L
  • Magnesium chloride hexahydrate 0.0503g/L
  • Sodium chloride 5.33g/L
  • Sodium lactate 7.4g/L

Dosage Form:
Dialysis solution

New Zealand Sponsor:
Baxter Healthcare Limited

Manufacturer:
Baxter Healthcare Pty Limited, Sydney, Australia

Note: This renewed consent is valid for two years from 12 September 2017.

Product:
Dianeal PD-4 Peritoneal Dialysis Solution

Active Ingredients:

  • Calcium chloride dihydrate 0.181g/L
  • Glucose monohydrate 5.45g/L
  • Magnesium chloride hexahydrate 0.0503g/L
  • Sodium chloride 5.33g/L
  • Sodium lactate 7.4g/L

Dosage Form:
Dialysis solution

New Zealand Sponsor:
Baxter Healthcare Limited

Manufacturer:
Baxter Healthcare Pty Limited, Sydney, Australia

Note: This renewed consent is valid for two years from 12 September 2017.

Product:
Fentanyl

Active Ingredient:
Fentanyl citrate 15.71mg/L equivalent to fentanyl 10mg/L

Dosage Form:
Solution for infusion

New Zealand Sponsor:
Biomed Limited

Manufacturer:
Biomed Limited, Auckland, New Zealand

Note: This renewed consent is valid for two years from 23 September 2017.

Product:
Fentanyl

Active Ingredient:
Fentanyl citrate 31.42mg/L equivalent to fentanyl 20mg/L

Dosage Form:
Solution for infusion

New Zealand Sponsor:
Biomed Limited

Manufacturer:
Biomed Limited, Auckland, New Zealand

Note: This renewed consent is valid for two years from 23 September 2017.

Dated this 1st day of September 2017.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

2017-go4653

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

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2017, No 90





✨ LLM interpretation of page content

πŸ₯ Renewal of Provisional Consent to the Distribution of Medicines

πŸ₯ Health & Social Welfare
1 September 2017
Medicines, Provisional Consent, Renewal, Dianeal, Fentanyl
  • CHRIS JAMES, Group Manager, Medsafe, Ministry of Health

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
Medicines, Distribution Consent, Schedule