Notice Title

Renewal of Provisional Consent to the Distribution of Medicines

Publication Date
26 Mar 2026

Tags

Medicines Act Renewal of provisional consent to the distribution of medicines Health

Notice Number

2026-sl1630
Title
View PDF
File Type and Size
PDF (25 KB)

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicines set out in the Schedule hereto:

Schedule

Product: Codral Original Cold & Flu
Active Ingredients: Paracetamol 500mg
Pseudoephedrine hydrochloride 30mg
Dosage Form: Tablet
New Zealand Sponsor: JNTL Consumer Health (New Zealand) Limited
Manufacturer: Kenvue SA (Pty) Limited t/a Kenvue SA, Cape Town, South Africa
Note: This renewed consent is valid for one year from 12 April 2026.
 
Product: Codral Original Day & Night
Component 1:  
Active Ingredients: Paracetamol 500mg
Pseudoephedrine hydrochloride 30mg
Dosage Form: Day tablet Tablet
Component 2:  
Active Ingredients: Paracetamol 500mg
Pseudoephedrine hydrochloride 30mg
Triprolidine hydrochloride monohydrate 1.25mg
Dosage Form: Night tablet Tablet
New Zealand Sponsor: JNTL Consumer Health (New Zealand) Limited
Manufacturer: Kenvue SA (Pty) Limited t/a Kenvue SA, Cape Town, South Africa
Note: This renewed consent is valid for one year from 12 April 2026.
 
Product: Demazin Original Cold + Flu Relief Day + Night
Component 1:  
Active Ingredients: Paracetamol 500mg
Pseudoephedrine hydrochloride 30mg
Dosage Form: Tablet
Component 2:  
Active Ingredients: Chlorphenamine maleate 2mg
Paracetamol 500mg
Pseudoephedrine hydrochloride 30mg
Dosage Form: Tablet
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturer: Probiotec Pharma Pty Limited, Melbourne, Australia
Note: This renewed consent is valid for one year from 12 April 2026.
 
Product: Scopolamine Transdermal System
Active Ingredient: Hyoscine 1.45mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Viatris Limited
Manufacturer: Mylan Technologies Inc., Vermont, United States of America

Note: This consent is given subject to the following condition:

  • The medicine may only be marketed or distributed when no other scopolamine (hyoscine) transdermal patch medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet PHARMAC supply obligations.
Note: This renewed consent is valid for two years from 4 April 2026.
 
Product: Sudafed Sinus and Nasal Decongestant
Active Ingredient: Pseudoephedrine hydrochloride 60mg
Dosage Form: Tablet
New Zealand Sponsor: JNTL Consumer Health (New Zealand) Limited
Manufacturer: Kenvue SA (Pty) Limited t/a Kenvue SA, Cape Town, South Africa
Note: This renewed consent is valid for one year from 12 April 2026.


Dated this 23rd day of March 2026.

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