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: | Amikacin (Medicianz) |
| Active Ingredient: | Amikacin sulfate 333.8mg/mL equivalent to amikacin 250mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | Anfarm Hellas SA, Schimatari, Greece |
| Product: | Amikacin (Medsurge) |
| Active Ingredient: | Amikacin sulfate 333.8mg/mL equivalent to amikacin 250mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | Anfarm Hellas SA, Schimatari, Greece |
| Product: | Amphotericin Liposomal SUN |
| Active Ingredient: | Amphotericin B 50mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | CARSL Consulting |
| Manufacturer: | Sun Pharmaceutical Medicare Limited, Ujeti, India |
| Product: | Chlorhexidine 4% Aqueous Solution |
| Active Ingredient: | Chlorhexidine gluconate 4%w/v |
| Dosage Form: | Topical solution |
| New Zealand Sponsor: | Jaychem Industries Limited |
| Manufacturer: | Jaychem Industries Limited, Auckland, New Zealand |
| Product: | SomniCare |
| Active Ingredient: | Melatonin 2mg |
| Dosage Form: | Modified release tablet |
| New Zealand Sponsor: | AFT Pharmaceuticals Limited |
| Manufacturer: | Recipharm Parets SL, Barcelona, Spain |
Dated this 5th day of June 2024.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on the 11 September 2013).