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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
| Product: | Beovu (27.6mg/0.23mL) |
| Active Ingredient: | Brolucizumab 120mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Novartis Pharma Stein AG, Stein, Switzerland |
| Product: | Beovu (Pre-filled syringe 19.8mg/0.165mL) |
| Active Ingredient: | Brolucizumab 120mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Alcon Couvreur NV, Puurs, Belgium |
| Product: | Circadin |
| Active Ingredient: | Melatonin 2mg |
| Dosage Form: | Modified release tablet |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | Rovi Pharma Industrial Services S.A., Madrid, Spain SwissCo Services AG, Sisseln, Switzerland Iberfar - Industria Farmaceutica S.A., Barcarena, Portugal |
| Product: | Gardasil 9 |
| Active Ingredients: | Human Papillomavirus (HPV) 11 L1 Protein 40mcg Human Papillomavirus (HPV) 16 L1 Protein 60mcg Human Papillomavirus (HPV) 18 L1 Protein 40mcg Human Papillomavirus (HPV) 31 L1 Protein 20mcg Human Papillomavirus (HPV) 33 L1 Protein 20mcg Human Papillomavirus (HPV) 45 L1 Protein 20mcg Human Papillomavirus (HPV) 52 L1 Protein 20mcg Human Papillomavirus (HPV) 58 L1 Protein 20mcg Human Papillomavirus (HPV) 6 L1 Protein 30mcg |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | Merck Sharp & Dohme (New Zealand) Limited |
| Manufacturers: | MSD International GmbH (Ireland), Carlow, Ireland Merck Sharp & Dohme LLC, Pennsylvania, United States of America |
| Product: | Slenyto |
| Active Ingredient: | Melatonin 1mg |
| Dosage Form: | Modified release tablet |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | SwissCo Services AG, Sisseln, Switzerland Dragenopharm, Apotheker Puschl GmbH & Co. KG, Tittmoning, Germany Iberfar - Industria Farmaceutica S.A., Barcarena, Portugal |
| Product: | Slenyto |
| Active Ingredient: | Melatonin 5mg |
| Dosage Form: | Modified release tablet |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | SwissCo Services AG, Sisseln, Switzerland Dragenopharm, Apotheker Puschl GmbH & Co. KG, Tittmoning, Germany Iberfar - Industria Farmaceutica S.A., Barcarena, Portugal |
| Product: | Vigisom |
| Active Ingredient: | Melatonin 2mg |
| Dosage Form: | Modified release tablet |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | Rovi Pharma Industrial Services, S.A., Madrid, Spain SwissCo Services AG, Sisseln, Switzerland Iberfar - Industria Farmaceutica S.A., Barcarena, Portugal |
Dated this 15th day of May 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).