β¨ 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
52
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β¨ LLM interpretation of page content
π₯ Renewal of Provisional Consent to the Distribution of Medicines
π₯ Health & Social Welfare1 September 2017
Medicines, Provisional Consent, Renewal, Dianeal, Fentanyl
- CHRIS JAMES, Group Manager, Medsafe, Ministry of Health
π₯ Consent to the Distribution of New Medicines
π₯ Health & Social WelfareMedicines, Distribution Consent, Schedule
NZ Gazette 2017, No 90