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 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:
| Product: | Cinacalcet Devatis 30mg Film-coated Tablet |
| Active Ingredient: | Cinacalcet hydrochloride 33.06mg equivalent to cinacalcet 30mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Devatis Limited |
| Manufacturer: | Deva Holding AS, Tekirdag, Turkey |
| Product: | Cinacalcet Devatis 60mg Film-coated Tablet |
| Active Ingredient: | Cinacalcet hydrochloride 66.12mg equivalent to cinacalcet 60mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Devatis Limited |
| Manufacturer: | Deva Holding AS, Tekirdag, Turkey |
| Product: | Cinacalcet Devatis 90mg Film-coated Tablet |
| Active Ingredient: | Cinacalcet hydrochloride 99.18mg equivalent to cinacalcet 90mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Devatis Limited |
| Manufacturer: | Deva Holding AS, Tekirdag, Turkey |
| Product: | ELOCTATE |
| Active Ingredient: | Efmoroctocog alfa 250IU |
| Dosage Form: | Powder for infusion with diluent |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany Patheon Italia S.p.A, Ferentino, Italy |
| Product: | ELOCTATE |
| Active Ingredient: | Efmoroctocog alfa 500IU |
| Dosage Form: | Powder for infusion with diluent |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany Patheon Italia S.p.A, Ferentino, Italy |
| Product: | ELOCTATE |
| Active Ingredient: | Efmoroctocog alfa 1000IU |
| Dosage Form: | Powder for infusion with diluent |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany Patheon Italia S.p.A, Ferentino, Italy |
| Product: | ELOCTATE |
| Active Ingredient: | Efmoroctocog alfa 2000IU |
| Dosage Form: | Powder for infusion with diluent |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany Patheon Italia S.p.A, Ferentino, Italy |
| Product: | ELOCTATE |
| Active Ingredient: | Efmoroctocog alfa 3000IU |
| Dosage Form: | Powder for infusion with diluent |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany Patheon Italia S.p.A, Ferentino, Italy |
| Product: | ENHERTU |
| Active Ingredient: | Trastuzumab deruxtecan 100mg |
| Dosage Form: | Powder for infusion concentrate |
| New Zealand Sponsor: | AstraZeneca Limited |
| Manufacturer: | Baxter Deutschland GmbH, Halle-Kunsebeck, Germany |
| Product: | Kalydeco |
| Active Ingredient: | Ivacaftor 25mg |
| 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 Catalent Greenville Inc, North Carolina, United States of America |
| Product: | Kalydeco |
| Active Ingredient: | Ivacaftor 50mg |
| 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 Catalent Greenville Inc, North Carolina, United States of America |
| Product: | Kalydeco |
| 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 Catalent Greenville Inc, North Carolina, United States of America |
| Product: | Kalydeco |
| Active Ingredient: | Ivacaftor 150mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | Rottendorf Pharma GmbH, Ennigerloh, Germany Patheon Pharmaceuticals Inc, Ohio, United States of America |
| Product: | Ziextenzo |
| Active Ingredient: | Pegfilgrastim 10mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Sandoz New Zealand Limited |
| Manufacturer: | Novartis Pharmaceutical Manufacturing GmbH, Langkampfen, Austria |
Dated this 20th day of May 2025.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).