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: | Abevmy |
| Active Ingredient: | Bevacizumab 25mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Biocon Biologics India Limited, Bengaluru, India |
| Product: | Ibuprofen 12 Hour |
| Active Ingredient: | Ibuprofen 300mg |
| Dosage Form: | Modified release tablet |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Strides Pharma Science Limited, Puducherry, India |
| Product: | Melpha |
| Active Ingredient: | Melphalan hydrochloride 11.1946mg/mL equivalent to melphalan 10mg |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Luminaire Group Limited |
| Manufacturer: | Emcure Pharmaceuticals Limited, Pune, India |
| Product: | Nurofen 12 Hour |
| Active Ingredient: | Ibuprofen 300mg |
| Dosage Form: | Modified release tablet |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Strides Pharma Science Limited, Puducherry, India |
| Product: | Skyrizi (Pre-filled pen) |
| Active Ingredient: | Risankizumab 150mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | AbbVie Limited |
| Manufacturer: | AbbVie Biotechnology Limited, Barceloneta, Puerto Rico |
| Product: | Skyrizi (Pre-filled syringe) |
| Active Ingredient: | Risankizumab 150mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | AbbVie Limited |
| Manufacturer: | AbbVie Biotechnology Limited, Barceloneta, Puerto Rico |
| Product: | Trelegy Ellipta 200/62.5/25 |
| Active Ingredients: | Fluticasone furoate 200mcg Umeclidinium bromide 74.2mcg equivalent to umeclidinium 62.5mcg Vilanterol trifenatate 40mcg equivalent to vilanterol 25mcg |
| Dosage Form: | Powder for inhalation |
| New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
| Manufacturer: | Glaxo Operations UK Limited t/a Glaxo Wellcome Operations, Ware, United Kingdom |
| Product: | Tryzan |
| Active Ingredient: | Ramipril 1.25mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Mylan Laboratories Limited, Sinnar, India |
| Product: | Tryzan |
| Active Ingredient: | Ramipril 2.5mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Mylan Laboratories Limited, Sinnar, India |
| Product: | Tryzan |
| Active Ingredient: | Ramipril 5mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Mylan Laboratories Limited, Sinnar, India |
| Product: | Tryzan |
| Active Ingredient: | Ramipril 10mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Mylan Laboratories Limited, Sinnar, India |
Dated this 16th day of May 2022.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).