Notice Type
Departmental
Notice Title

Renewal of Provisional Consent to the Distribution of Medicines

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicines set out in the Schedule hereto:

Schedule

Product: Daunorubicin
Active Ingredient: Daunorubicin hydrochloride 2.14mg/mL equivalent to daunorubicin 2mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer (Perth) Pty Limited, Perth, Australia
Note: This renewed consent is valid for two years from 26 September 2019. 
   
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 2019.
   
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 2019.


Dated this 6th day of September 2019.

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