Notice Title

Consent to the Distribution of New Medicines

Publication Date
17 Apr 2025

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2025-go2095
Title
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File Type and Size
PDF (37 KB)

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: Betadine Sore Throat Lozenges
Active Ingredients: Amylmetacresol 0.6mg
Dichlorobenzyl alcohol 1.2mg
Dosage Form: Lozenge
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturer: Unique Pharmaceuticals Laboratories, Kadaiya, India
   
Product: Demazin Allergy + Hayfever Relief
Active Ingredient: Loratadine 10mg
Dosage Form: Tablet
New Zealand Sponsor: Noumed Pharmaceuticals Limited
Manufacturer: Noumed Life Sciences Limited, Maidenhead, United Kingdom
   
Product: Demazin Hayfever Relief
Active Ingredient: Loratadine 10mg
Dosage Form: Tablet
New Zealand Sponsor: Noumed Pharmaceuticals Limited
Manufacturer: Noumed Life Sciences Limited, Maidenhead, United Kingdom
   
Product: Loratadine (General Sale)
Active Ingredient: Loratadine 10mg
Dosage Form: Tablet
New Zealand Sponsor: Noumed Pharmaceuticals Limited
Manufacturer: Noumed Life Sciences Limited, Maidenhead, United Kingdom
   
Product: Loratadine (Pharmacy Only)
Active Ingredient: Loratadine 10mg
Dosage Form: Tablet
New Zealand Sponsor: Noumed Pharmaceuticals Limited
Manufacturer: Noumed Life Sciences Limited, Maidenhead, United Kingdom
   
Product: Sugammadex Kabi (200mg/2mL)
Active Ingredient: Sugammadex sodium 108.8mg/mL equivalent to sugammadex 100mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Fresenius Kabi New Zealand Limited
Manufacturer: Labesfal Laboratories Almiro SA, Santiago de Besteiros, Portugal
   
Product: Sugammadex Kabi (500mg/5mL)
Active Ingredient: Sugammadex sodium 108.8mg/mL equivalent to sugammadex 100mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Fresenius Kabi New Zealand Limited
Manufacturer: Labesfal Laboratories Almiro SA, Santiago de Besteiros, Portugal


Dated this 14th day of April 2025.

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