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 are set out in the Schedule hereto:

Schedule

*Product:*	Avtozma (80mg/4mL)
Active Ingredient:	Tocilizumab 20mg/mL
Dosage Form:	Concentrate for infusion
New Zealand Sponsor:	Celltrion Healthcare New Zealand Limited
Manufacturer:	Samsung Biologics Co Limited, Incheon, South Korea

*Product:*	Avtozma (pre-filled pen)
Active Ingredient:	Tocilizumab 180mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Celltrion Healthcare New Zealand Limited
Manufacturer:	Celltrion Pharm Inc, Cheongju-si, South Korea

*Product:*	Avtozma (Pre-filled Syringe)
Active Ingredient:	Tocilizumab 180mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Celltrion Healthcare New Zealand Limited
Manufacturer:	Celltrion Pharm Inc, Cheongju-si, South Korea

*Product:*	Avtozma (200mg/10mL)
Active Ingredient:	Tocilizumab 20mg/mL
Dosage Form:	Concentrate for infusion
New Zealand Sponsor:	Celltrion Healthcare New Zealand Limited
Manufacturer:	Baxter Oncology GmbH, Halle-Westfalen, Germany

*Product:*	Avtozma (400mg/20mL)
Active Ingredient:	Tocilizumab 20mg/mL
Dosage Form:	Concentrate for infusion
New Zealand Sponsor:	Celltrion Healthcare New Zealand Limited
Manufacturer:	Baxter Oncology GmbH, Halle-Westfalen, Germany

*Product:*	Difflam Antibacterial
Active Ingredients:	Amylmetacresol 0.6mg Dichlorobenzyl alcohol 1.2mg
Dosage Form:	Lozenge
New Zealand Sponsor:	iNova Pharmaceuticals (New Zealand) Limited
Manufacturer:	Unique Pharmaceuticals Laboratories, Nani Daman, India

*Product:*	Duocaine
Active Ingredients:	Lidocaine 25mg/g Prilocaine 25mg/g
Dosage Form:	Topical cream
New Zealand Sponsor:	Multichem NZ Limited
Manufacturer:	Gracure Pharmaceuticals Limited, Bhiwadi, India

*Product:*	Dycotex
Active Ingredients:	Docusate sodium 50mg Sennoside A+B calcium 8mg equivalent to Sennosides 13.30mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Maple Healthcare Limited
Manufacturer:	Evertogen Life Sciences Limited, Polepally, India

*Product:*	Labixten Syrup
Active Ingredient:	Bilastine 2.5mg/mL
Dosage Form:	Oral solution
New Zealand Sponsor:	A. Menarini New Zealand Pty Limited
Manufacturer:	Berlin-Chemie AG, Berlin, Germany

Dated this 28th day of November 2025.

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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