Consent to the Distribution of New Medicines
Pursuant 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:
| Product: | Labixten meltlets double strength |
| Active Ingredient: | Bilastine 20mg |
| Dosage Form: | Orodispersible tablet |
| New Zealand Sponsor: | A. Menarini New Zealand Pty Limited |
| Manufacturer: | Faes Farma S.A, Leioa, Spain |
| Product: | Trikafta 100/50/75 |
| Component 1: | |
| Active Ingredients: | Elexacaftor 100mg Ivacaftor 75mg Tezacaftor 50mg |
| Dosage Form: | Oral granules |
| Component 2: | |
| Active Ingredient: | Ivacaftor 75mg |
| Dosage Form: | Oral granules |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | Almac Pharma Services Limited, Craigavon, United Kingdom Halo Pharmaceutical Inc, New Jersey, United States of America Pharmaceutical Manufacturing Research Services Inc, Pennsylvania, United States of America Catalent Greenville Inc, North Carolina, United States of America |
| Product: | Trikafta 80/40/60 |
| Component 1: | |
| Active Ingredients: | Elexacaftor 80mg Ivacaftor 60mg Tezacaftor 40mg |
| Dosage Form: | Oral granules |
| Component 2: | |
| Active Ingredient: | Ivacaftor 59.5mg |
| Dosage Form: | Oral granules |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | Almac Pharma Services Limited, Craigavon, United Kingdom Halo Pharmaceutical Inc, New Jersey, United States of America Pharmaceutical Manufacturing Research Services Inc, Pennsylvania, United States of America Catalent Greenville Inc, North Carolina, United States of America |
| Product: | Wegovy |
| Active Ingredient: | Semaglutide 0.68mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novo Nordisk Pharmaceuticals Limited |
| Manufacturers: | Novo Nordisk A/S, Hovedstaden, Denmark Novo Nordisk A/S, Hillerod, Denmark |
| Product: | Wegovy (0.5mg FlexTouch) |
| Active Ingredient: | Semaglutide 1.34mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novo Nordisk Pharmaceuticals Limited |
| Manufacturers: | Novo Nordisk A/S, Hovedstaden, Denmark Novo Nordisk A/S, Hillerod, Denmark |
| Product: | Wegovy (1mg FlexTouch) |
| Active Ingredient: | Semaglutide 1.34mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novo Nordisk Pharmaceuticals Limited |
| Manufacturers: | Novo Nordisk A/S, Hovedstaden, Denmark Novo Nordisk A/S, Hillerod, Denmark |
| Product: | Wegovy |
| Active Ingredient: | Semaglutide 2.27mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novo Nordisk Pharmaceuticals Limited |
| Manufacturers: | Novo Nordisk A/S, Hovedstaden, Denmark Novo Nordisk A/S, Hillerod, Denmark |
| Product: | Wegovy |
| Active Ingredient: | Semaglutide 3.2mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novo Nordisk Pharmaceuticals Limited |
| Manufacturers: | Novo Nordisk A/S, Hovedstaden, Denmark Novo Nordisk A/S, Hillerod, Denmark |
Dated this 14th day of March 2025.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).