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: | Cetrotide |
| Active Ingredient: | Cetrorelix acetate 0.26mg equivalent to cetrorelix 0.25mg |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | Baxter Oncology GmbH, Westfalen, Germany Fareva Pau SAS, Idron, France |
| Product: | Duofilm |
| Active Ingredients: | Lactic acid 16.7%w/w Salicylic acid 16.7%w/w |
| Dosage Form: | Topical solution |
| New Zealand Sponsor: | Nice-Pak Products (NZ) Limited |
| Manufacturers: | Stiefel Laboratories (Ireland) Limited, Sligo, Ireland Delpharm Bladel B.V., Bladel, Netherlands |
| Product: | Eltroxin |
| Active Ingredient: | Levothyroxine sodium pentahydrate 111.26mcg equivalent to levothyroxine sodium 100mcg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Aspen Bad Oldesloe GmbH, Bad Oldesloe, Germany |
| Product: | Rozlytrek |
| Active Ingredient: | Entrectinib 100mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturer: | Mayne Pharma Inc, North Carolina, United States of America |
| Product: | Rozlytrek |
| Active Ingredient: | Entrectinib 200mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturer: | Mayne Pharma Inc, North Carolina, United States of America |
Dated this 19th day of June 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).