Gazette.govt.nzPursuant 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: | Codral Plus Mucus Cough + Cold & Flu |
| Component 1: | |
| Active Ingredients: | Paracetamol 500mg Phenylephrine hydrochloride 5mg |
| Dosage Form: | Tablet |
| Component 2: | |
| Active Ingredient: | Guaifenesin 20mg/mL |
| Dosage Form: | Oral solution |
| New Zealand Sponsor: | JNTL Consumer Health (New Zealand) Limited |
| Manufacturers: | Probiotec Pharma Pty Limited, Melbourne, Australia Delpharm Orleans, Orleans Cedex, France |
| Product: | Ibuprofen |
| Active Ingredient: | Ibuprofen 200mg |
| Dosage Form: | Liquid filled capsule |
| New Zealand Sponsor: | Multichem NZ Limited |
| Manufacturer: | Geltec Private Limited, Bangalore, India |
| Product: | INVEGA HAFYERA (700mg) |
| Active Ingredient: | Paliperidone palmitate 312mg/mL equivalent to paliperidone 200mg/mL |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturer: | Janssen Pharmaceutica NV, Beerse, Belgium |
| Product: | INVEGA HAFYERA (1000mg) |
| Active Ingredient: | Paliperidone palmitate 312mg/mL equivalent to paliperidone 200mg/mL |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturer: | Janssen Pharmaceutica NV, Beerse, Belgium |
| Product: | Naproxen Anti-Inflammatory Pain Relief |
| Active Ingredient: | Naproxen sodium 275mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Noumed Pharmaceuticals Limited |
| Manufacturer: | Medreich Limited, Bangalore, India |
Dated this 4th day of September 2023.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).