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:*	Apohealth Melatonin
Active Ingredient:	Melatonin 2mg
Dosage Form:	Modified release tablet
New Zealand Sponsor:	Arrotex Pharmaceuticals (NZ) Limited
Manufacturers:	Oman Pharmaceutical Products Company LLC, Salalah, Oman Gracure Pharmaceuticals Limited, Bhiwadi, India

*Product:*	Melotin
Active Ingredient:	Melatonin 2mg
Dosage Form:	Modified release tablet
New Zealand Sponsor:	Arrotex Pharmaceuticals (NZ) Limited
Manufacturers:	Oman Pharmaceutical Products Company LLC, Salalah, Oman Gracure Pharmaceuticals Limited, Bhiwadi, India

*Product:*	Vigisom
Active Ingredient:	Melatonin 2mg
Dosage Form:	Modified release tablet
New Zealand Sponsor:	Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturers:	Rovi Pharma Industrial Services, S.A., Madrid, Spain SwissCo Services AG, Sisseln, Switzerland Iberfar – Industria Farmaceutica S.A., Barcarena, Portugal

Dated this 11th day of September 2025.

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

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