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:*	Dasatinib Dr.Reddy’s
Active Ingredient:	Dasatinib (S)-propylene glycol solvate 23.2mg equivalent to 20mg dasatinib
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Dr Reddy’s New Zealand Limited
Manufacturer:	Aizant Drug Research Solutions Pvt Limited, Hydrerabad, India

*Product:*	Dasatinib Dr.Reddy’s
Active Ingredient:	Dasatinib (S)-propylene glycol solvate 58mg equivalent to 50mg dasatinib
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Dr Reddy’s New Zealand Limited
Manufacturer:	Aizant Drug Research Solutions Pvt Limited, Hydrerabad, India

*Product:*	Dasatinib Dr.Reddy’s
Active Ingredient:	Dasatinib (S)-propylene glycol solvate 81.2mg equivalent to 70mg dasatinib
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Dr Reddy’s New Zealand Limited
Manufacturer:	Aizant Drug Research Solutions Pvt Limited, Hydrerabad, India

*Product:*	Dasatinib Dr.Reddy’s
Active Ingredient:	Dasatinib (S)-propylene glycol solvate 116mg equivalent to 100mg dasatinib
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Dr Reddy’s New Zealand Limited
Manufacturer:	Aizant Drug Research Solutions Pvt Limited, Hydrerabad, India

*Product:*	Ryeqo 40/1/0.5
Active Ingredients:	Estradiol hemihydrate 1.032mg equivalent to estradiol 1.0mg Norethisterone acetate 0.5mg Relugolix 40mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Pharmbio Pty Limited
Manufacturer:	Patheon Inc, Ontario, Canada

*Product:*	Zoledronic Acid SUN
Active Ingredient:	Zoledronic acid monohydrate 0.0533mg/mL equivalent to zoledronic acid 0.05mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	CARSL Consulting
Manufacturer:	Sun Pharmaceutical Industries Limited, Halol, India

Dated this 20th day of October 2023.

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

Tags

Notice Number

Schedule