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

*Product:*	Cyclonex
Active Ingredient:	Cyclophosphamide monohydrate 53.5mg equivalent to cyclophosphamide 50mg
Dosage Form:	Tablet
New Zealand Sponsor:	CARSL Consulting
Manufacturer:	Idifarma Desarrollo Farmaceutico S.L, Noain, Spain

*Product:*	Ketamine
Active Ingredient:	Ketamine hydrochloride 1.153mg/mL equivalent to ketamine 1mg/mL
Dosage Form:	Solution for infusion
New Zealand Sponsor:	Biomed Limited
Manufacturer:	Biomed Limited, Auckland, New Zealand

*Product:*	Ketamine
Active Ingredient:	Ketamine hydrochloride 11.53mg/mL equivalent to ketamine 10mg/mL
Dosage Form:	Solution for infusion
New Zealand Sponsor:	Biomed Limited
Manufacturer:	Biomed Limited, Auckland, New Zealand

*Product:*	Zematop
Active Ingredient:	Tacrolimus monohydrate 1.022mg/g equivalent to tacrolimus 1mg/g
Dosage Form:	Topical ointment
New Zealand Sponsor:	Douglas Pharmaceuticals Limited
Manufacturer:	Intas Pharmaceuticals Limited, Sanand, India

Dated this 6th day of April 2021.

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

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