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: | Allertec Allergy Relief (Pharmacy only) |
| Active Ingredient: | Cetirizine hydrochloride 10mg |
| Dosage Form: | Soft gelatin capsule |
| New Zealand Sponsor: | AdiraMedica Pty Limited. |
| Manufacturer: | Softgel Healthcare Pvt. Limited, Kancheepuram, India |
| Product: | Allertec Hayfever Relief (General sale) |
| Active Ingredient: | Cetirizine hydrochloride 10mg |
| Dosage Form: | Soft gelatin capsule |
| New Zealand Sponsor: | AdiraMedica Pty Limited. |
| Manufacturer: | Softgel Healthcare Pvt. Limited, Kancheepuram, India |
| Product: | ENHERTU |
| Active Ingredient: | Trastuzumab deruxtecan 100mg |
| Dosage Form: | Powder for concentrate for infusion |
| New Zealand Sponsor: | AstraZeneca Limited |
| Manufacturer: | Baxter Oncology GmbH, Halle-Kunsebeck Westfalen, Germany |
| Product: | Mayzent |
| Active Ingredient: | Siponimod fumarate 1.112mg equivalent to siponimod 1mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Novartis Pharma Stein AG, Stein, Switzerland |
| Product: | Uramet |
| Active Ingredient: | Methenamine hippurate 1g |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Aspen Pharma Pty Limited, Melbourne, Australia |
Dated this 4th day of December 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).