Notice Type
Departmental
Notice Title

Provisional Consent to the Distribution of New Medicines

Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicines set out in the Schedule hereto:

Schedule

Product: Chemists’ Own Day + Night Cold & Flu Relief
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: Noumed Pharmaceuticals Limited
Manufacturer: Probiotec Pharma Pty Limited, Melbourne, Australia
Note: This consent is given subject to the following condition:
  • An application for consent under section 20 of the Medicines Act 1981 must be submitted by 1 May 2025.
Also Note: This consent is valid for two years from the date of publication of this notice.
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: Johnson & Johnson Pty Limited, Cape Town, South Africa
Note: This consent is given subject to the following condition:
  • An application for consent under section 20 of the Medicines Act 1981 must be submitted by 1 May 2025.
Also Note: This consent is valid for two years from the date of publication of this notice.
Product: Codral Original Day & Night
Component 1:  
Active Ingredients: Paracetamol 500mg
Pseudoephedrine hydrochloride 30mg
Dosage Form: Day Tablet
Component 2:  
Active Ingredients: Paracetamol 500mg
Pseudoephedrine hydrochloride 30mg
Triprolidine hydrochloride monohydrate 1.25mg
Dosage Form: Night Tablet
New Zealand Sponsor: JNTL Consumer Health (New Zealand) Limited
Manufacturer: Johnson & Johnson Pty Limited, Cape Town, South Africa
Note: This consent is given subject to the following condition:
  • An application for consent under section 20 of the Medicines Act 1981 must be submitted by 1 May 2025.
Also Note: This consent is valid for two years from the date of publication of this notice.
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 consent is given subject to the following condition:
  • An application for consent under section 20 of the Medicines Act 1981 must be submitted by 1 May 2025.
Also Note: This consent is valid for two years from the date of publication of this notice.
Product: Noumed Cold & Flu Relief
Active Ingredients: Paracetamol 500mg
Pseudoephedrine hydrochloride 30mg
Dosage Form: Tablet
New Zealand Sponsor: Noumed Pharmaceuticals Limited
Manufacturer: Probiotec Pharma Pty Limited, Melbourne, Australia
Note: This consent is given subject to the following condition:
  • An application for consent under section 20 of the Medicines Act 1981 must be submitted by 1 May 2025.
Also Note: This consent is valid for two years from the date of publication of this notice.
Product: Noumed Day + Night Cold & Flu Relief
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: Noumed Pharmaceuticals Limited
Manufacturer: Probiotec Pharma Pty Limited, Melbourne, Australia
Note: This consent is given subject to the following condition:
  • An application for consent under section 20 of the Medicines Act 1981 must be submitted by 1 May 2025.
Also Note: This consent is valid for two years from the date of publication of this notice.
Product: Noumed Decongestant Tablets
Active Ingredient: Pseudoephedrine hydrochloride 60mg
Dosage Form: Tablet
New Zealand Sponsor: Noumed Pharmaceuticals Limited
Manufacturer: Probiotec Pharma Pty Limited, Melbourne, Australia
Note: This consent is given subject to the following condition:
  • An application for consent under section 20 of the Medicines Act 1981 must be submitted by 1 May 2025.
Also Note: This consent is valid for two years from the date of publication of this notice.
Product: Noumed Night Time Cold & Flu Relief
Active Ingredients: Chlorphenamine maleate 2mg
Paracetamol 500mg
Pseudoephedrine hydrochloride 30mg
Dosage Form: Tablet
New Zealand Sponsor: Noumed Pharmaceuticals Limited
Manufacturer: Probiotec Pharma Pty Limited, Melbourne, Australia
Note: This consent is given subject to the following condition:
  • An application for consent under section 20 of the Medicines Act 1981 must be submitted by 1 May 2025.
Also Note: This consent is valid for two years from the date of publication of this notice.
Product: Nurofen Cold & Flu with Decongestant
Active Ingredients: Ibuprofen 200mg
Pseudoephedrine hydrochloride 30mg
Dosage Form: Tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare International Limited, Nottingham, United Kingdom
Note: This consent is given subject to the following condition:
  • An application for consent under section 20 of the Medicines Act 1981 must be submitted by 1 May 2025.
Also Note: This consent is valid for two years from the date of publication of this notice.
Product: Sudafed Sinus + Pain Relief Day & Night
Component 1:  
Active Ingredients: Paracetamol 500mg
Pseudoephedrine hydrochloride 30mg
Dosage Form: Day Tablet
Component 2:  
Active Ingredients: Paracetamol 500mg
Pseudoephedrine hydrochloride 30mg
Triprolidine hydrochloride monohydrate 1.25mg
Dosage Form: Night Tablet
New Zealand Sponsor: JNTL Consumer Health (New Zealand) Limited
Manufacturer: Johnson & Johnson Pty Limited, Cape Town, South Africa
Note: This consent is given subject to the following condition:
  • An application for consent under section 20 of the Medicines Act 1981 must be submitted by 1 May 2025.
Also Note: This consent is valid for two years from the date of publication of this notice.
Product: Sudafed Sinus and Nasal Decongestant
Active Ingredient: Pseudoephedrine hydrochloride 60mg
Dosage Form: Tablet
New Zealand Sponsor: JNTL Consumer Health (New Zealand) Limited
Manufacturer: Johnson & Johnson Pty Limited, Cape Town, South Africa
Note: This consent is given subject to the following condition:
  • An application for consent under section 20 of the Medicines Act 1981 must be submitted by 1 May 2025.
Also Note: This consent is valid for two years from the date of publication of this notice.


Dated this 11th day of April 2024.

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