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: | Influvac Tetra |
| Active Ingredients: | Influenza virus A/Hong Kong/2671/2019 (H3N2)-like strain 15mcg Influenza virus A/Victoria/2570/2019 (H1N1) pdm09-like strain 15mcg Influenza virus B/Phuket/3073/2013-like strain 15mcg Influenza virus B/Washington/02/2019-like (B/Victoria lineage) virus 15mcg |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturers: | Abbott Biologicals BV, Olst, Netherlands Abbott Biologicals BV, Weesp, Netherlands |
| Product: | Skyrizi |
| Active Ingredient: | Risankizumab 75mg |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | AbbVie Limited |
| Manufacturers: | Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany AbbVie Biotechnology Limited, Barceloneta, Puerto Rico |
| Product: | Xolair (75mg/0.5mL) |
| Active Ingredient: | Omalizumab 150mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany |
| Product: | Xolair (150mg/mL) |
| Active Ingredient: | Omalizumab 150mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany |
| Product: | Xolair |
| Active Ingredient: | Omalizumab 150mg |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Novartis Pharma Stein AG, Stein, Switzerland |
Dated this 21st day of February 2022.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).