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:*	Andembry
Active Ingredient:	Garadacimab 167mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	CSL Behring (NZ) Limited
Manufacturer:	CSL Behring GmbH, Marburg, Germany

*Product:*	Calcitriol Devatis
Active Ingredient:	Calcitriol 0.25mcg
Dosage Form:	Soft gelatin capsule
New Zealand Sponsor:	Devatis Limited
Manufacturer:	Deva Holding AS, Tekirdag, Turkey

*Product:*	Calcitriol Devatis
Active Ingredient:	Calcitriol 0.5mcg
Dosage Form:	Soft gelatin capsule
New Zealand Sponsor:	Devatis Limited
Manufacturer:	Deva Holding AS, Tekirdag, Turkey

*Product:*	Carmustine
Active Ingredient:	Carmustine 100mg
Dosage Form:	Powder for injection with diluent
New Zealand Sponsor:	REX Medical Limited
Manufacturer:	MSN Laboratories Private Limited, Nandigama Village, India

*Product:*	Soolantra
Active Ingredient:	Ivermectin 10mg/g
Dosage Form:	Topical cream
New Zealand Sponsor:	Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer:	Laboratoires Galderma, Alby-sur-Cheran, France

*Product:*	Xolair (75mg/0.5mL) (pre-filled pen)
Active Ingredient:	Omalizumab 150mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturer:	Novartis Pharma Stein AG, Stein, Switzerland

*Product:*	Xolair (150mg/mL) (pre-filled pen)
Active Ingredient:	Omalizumab 150mg/mL
Dosage Form:	Solution for inhalation
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturer:	Novartis Pharma Stein AG, Stein, Switzerland

*Product:*	Xolair (300mg/2mL) (pre-filled pen)
Active Ingredient:	Omalizumab 150mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturer:	Novartis Pharma Stein AG, Stein, Switzerland

*Product:*	Xolair (75mg/0.5mL) (pre-filled syringe, with revised safety device)
Active Ingredient:	Omalizumab 150mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturer:	Novartis Pharma Stein AG, Stein, Switzerland

*Product:*	Xolair (150mg/mL) (pre-filled syringe, with revised safety device)
Active Ingredient:	Omalizumab 150mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturer:	Novartis Pharma Stein AG, Stein, Switzerland

*Product:*	Xolair (300mg/2mL) (pre-filled syringe, with revised safety device)
Active Ingredient:	Omalizumab 150mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturer:	Novartis Pharma Stein AG, Stein, Switzerland

Dated this 10th day of March 2026.

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