Notice Title

Consent to the Distribution of New Medicines

Publication Date
10 Apr 2025

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2025-go1917
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 medicine set out in the Schedule hereto:

Schedule

Product: Bactol 90% Alcohol Surgical Handrub
Active Ingredient: Ethanol 90.8%w/w equivalent to 90%v/v ethanol
Dosage Form: Topical solution
New Zealand Sponsor: Whiteley Corporation (NZ)
Manufacturer: Nowra Chemical Manufacturers Pty Limited T/A Nowchem Pharma, Nowra, Australia
   
Product: Children’s Loraclear (Bubblegum Flavour, General sale)
Active Ingredient: Loratadine 5mg
Dosage Form: Chewable tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: XL Laboratories Pvt. Limited, Bhiwadi, India
   
Product: Children’s Loraclear (Bubblegum Flavour, Pharmacy only)
Active Ingredient: Loratadine 5mg
Dosage Form: Chewable tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: XL Laboratories Pvt. Limited, Bhiwadi, India
   
Product: Children’s Loraclear (Grape Flavour, General sale)
Active Ingredient: Loratadine 5mg
Dosage Form: Chewable tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: XL Laboratories Pvt. Limited, Bhiwadi, India
   
Product: Children’s Loraclear (Grape Flavour, Pharmacy only)
Active Ingredient: Loratadine 5mg
Dosage Form: Chewable tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: XL Laboratories Pvt. Limited, Bhiwadi, India
   
Product: Fenofibrate Viatris
Active Ingredient: Fenofibrate 48mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Viatris Limited
Manufacturers: Fournier Laboratories Ireland Limited, Carrigtwohill, Ireland
Abbott Healthcare Private Limited, District Solan, India
   
Product: Fenofibrate Viatris
Active Ingredient: Fenofibrate 145mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Viatris Limited
Manufacturers: Fournier Laboratories Ireland Limited, Carrigtwohill, Ireland
Abbott Healthcare Private Limited, District Solan, India


Dated this 4th day of April 2025.

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