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:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Ketamine
Ketamine hydrochloride 1.153mg/mL equivalent to ketamine 1mg/mL
Solution for infusion
Biomed Limited
Biomed Limited, Auckland, New Zealand

Note: This renewed consent is valid for two years from 5 May 2019.

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Ketamine
Ketamine hydrochloride 11.53mg/mL equivalent to ketamine 10mg/mL
Solution for infusion
Biomed Limited
Biomed Limited, Auckland, New Zealand

Note: This renewed consent is valid for two years from 5 May 2019.

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

RiaSTAP
Fibrinogen 900mg – 1300mg
Powder for injection
CSL Behring (NZ) Limited
CSL Behring GmbH, Marburg, Germany

Note: This renewed consent is valid for two years from 12 May 2019.

Dated this 29th day of April 2019.

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