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: | Byooviz |
| Active Ingredient: | Ranibizumab 10mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Samsung Bioepis NZ Limited |
| Manufacturer: | Patheon Italia S.p.A, Milan, Italy |
| Product: | Nabota |
| Active Ingredient: | Botulinum toxin type A 100Units |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Douglas Pharmaceuticals Limited |
| Manufacturer: | Daewoong Pharmaceutical Co., Limited., Hwaseong-si, South Korea |
| Product: | Ozempic 1.5mL |
| Active Ingredient: | Semaglutide 1.34mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novo Nordisk Pharmaceuticals Limited |
| Manufacturers: | Novo Nordisk A/S, Copenhagen, Denmark Novo Nordisk A/S, Hillerod, Denmark |
| Product: | Ozempic 3mL |
| Active Ingredient: | Semaglutide 1.34mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novo Nordisk Pharmaceuticals Limited |
| Manufacturers: | Novo Nordisk A/S, Copenhagen, Denmark Novo Nordisk A/S, Hillerod, Denmark Novo Nordisk Pharmaceutical Industries, North Carolina, United States of America |
| Product: | Polivy |
| Active Ingredient: | Polatuzumab vedotin 140mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturer: | BSP Pharmaceuticals SpA, Latina, Italy |
| Product: | Renflexis |
| Active Ingredient: | Infliximab 100mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Samsung Bioepis NZ Limited |
| Manufacturer: | Patheon Italia S.p.A, Ferentino, Italy |
| Product: | Vannair 100/6 |
| Active Ingredients: | Budesonide 80mcg Formoterol fumarate 4.5mcg |
| Dosage Form: | Aerosol inhaler, metered dose |
| New Zealand Sponsor: | AstraZeneca Limited |
| Manufacturer: | AstraZeneca Dunkerque Production SCS, Dunkerque, France |
| Product: | Vannair 200/6 |
| Active Ingredients: | Budesonide 160mcg Formoterol fumarate 4.5mcg |
| Dosage Form: | Aerosol inhaler, metered dose |
| New Zealand Sponsor: | AstraZeneca Limited |
| Manufacturer: | AstraZeneca Dunkerque Production SCS, Dunkerque, France |
Dated this 13th day of March 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).