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:
| 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:
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| 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:
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| 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:
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| 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:
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| 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:
|
|
| 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:
|
|
| 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:
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| 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:
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| 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:
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| 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:
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| 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:
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| 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).