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:*	Crystacleanse Antiseptic Topical Solution
Active Ingredient:	Povidone-iodine 10%w/v equivalent to 1%w/v available iodine
Dosage Form:	Topical solution
New Zealand Sponsor:	Neo Pharma Limited
Manufacturer:	ICPA Health Products Limited, Ankleshwar, India

*Product:*	Flazaire Allergy
Active Ingredients:	Azelastine hydrochloride 0.989mg/g equivalent to 137mcg per spray Fluticasone propionate 0.361mg/g equivalent to 50mcg per spray
Dosage Form:	Nasal spray suspension
New Zealand Sponsor:	Sandoz New Zealand Limited
Manufacturer:	Teva Czech Industries SRO, Opava, Czech Republic

*Product:*	Maxiclear PSE Sinus & Pain Relief
Active Ingredients:	Paracetamol 500mg Pseudoephedrine hydrochloride 30mg
Dosage Form:	Soft gelatin capsule
New Zealand Sponsor:	Neo Pharma Limited
Manufacturer:	Olive Healthcare, Daman, India

*Product:*	Mekinist
Active Ingredient:	Trametinib dimethyl sulfoxide 5.3mg equivalent to trametinib 4.7mg
Dosage Form:	Powder for oral solution
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturer:	Novartis Pharmaceuticals S.R.L, Targu Mures, Romania

*Product:*	Neo Sinus + Pain Relief
Active Ingredients:	Paracetamol 500mg Pseudoephedrine hydrochloride 30mg
Dosage Form:	Soft gelatin capsule
New Zealand Sponsor:	Neo Pharma Limited
Manufacturer:	Olive Healthcare, Daman, India

*Product:*	Neodine Antiseptic Topical Solution
Active Ingredient:	Povidone-iodine 10%w/v equivalent to 1%w/v available iodine
Dosage Form:	Topical solution
New Zealand Sponsor:	Neo Pharma Limited
Manufacturer:	ICPA Health Products Limited, Ankleshwar, India

*Product:*	Paracetamol (General Sale)
Active Ingredient:	Paracetamol 500mg
Dosage Form:	Tablet
New Zealand Sponsor:	Multichem NZ Limited
Manufacturer:	Anqiu Lu’an Pharmaceutical Co Limited, Anqiu City, China

*Product:*	Paracetamol (Pharmacy Only)
Active Ingredient:	Paracetamol 500mg
Dosage Form:	Tablet
New Zealand Sponsor:	Multichem NZ Limited
Manufacturer:	Anqiu Lu’an Pharmaceutical Co Limited, Anqiu City, China

*Product:*	Tafinlar
Active Ingredient:	Dabrafenib mesilate 11.85mg equivalent to dabrafenib 10mg
Dosage Form:	Dispersible tablet
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturer:	Novartis Pharma Stein AG, Stein. Switzerland

*Product:*	Welireg
Active Ingredient:	Belzutifan 40mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Merck Sharp & Dohme (New Zealand) Limited
Manufacturer:	MSD International GmbH, t/a MSD Ireland (Ballydine), Clonmel, Ireland

Dated this 8th day of December 2025.

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