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: | Cabometyx |
| Active Ingredient: | Cabozantinib s-malate 25.34mg equivalent to carbonatitic 20mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | Rottendorf Pharma GmbH, Ennigerloh, Germany Patheon Inc, Mississauga, Ontario, Canada |
| Product: | Cabometyx |
| Active Ingredient: | Cabozantinib s-malate 50.69mg equivalent to cabozantinib 40mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | Rottendorf Pharma GmbH, Ennigerloh, Germany Patheon Inc, Mississauga, Ontario, Canada |
| Product: | Cabometyx |
| Active Ingredient: | Cabozantinib s-malate 76.03mg equivalent to cabozantinib 60mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | Rottendorf Pharma GmbH, Ennigerloh, Germany Patheon Inc, Mississauga, Ontario, Canada |
| Product: | HERZUMA |
| Active Ingredient: | Trastuzumab 150mg |
| Dosage Form: | Powder for infusion concentrate |
| New Zealand Sponsor: | Celltrion Healthcare New Zealand Limited |
| Manufacturers: | Celltrion Inc., Incheon, South Korea Gensenta llac Sanayii ve Ticaret A.S., Instanbul, Turkey |
| Product: | HERZUMA |
| Active Ingredient: | Trastuzumab 440mg |
| Dosage Form: | Powder for infusion concentrate |
| Dosage Form: | Diluent |
| New Zealand Sponsor: | Celltrion Healthcare New Zealand Limited |
| Manufacturer: | Celltrion Inc., Incheon, South Korea |
| Product: | Maviret |
| Active Ingredients: | Glecaprevir 100mg Pibrentasvir 40mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | AbbVie Limited |
| Manufacturers: | AbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany Fournier Laboratories Ireland Limited, Carrigtwohill, Ireland |
| Product: | MMR II Vaccine |
| Active Ingredients: | Measles vaccine 1000TCID50 Mumps vaccine 12500TCID50 Rubella vaccine 1000TCID50 |
| Dosage Form: | Suspension for injection |
| Dosage Form: | Diluent |
| New Zealand Sponsor: | Merck Sharp & Dohme (New Zealand) Limited |
| Manufacturers: | Merck Sharp & Dohme LLC, Pennsylvania, United States of America Merck Sharp & Dohme LLC, North Carolina, United States of America |
| Product: | ProQuad |
| Active Ingredients: | Measles vaccine 1000TCID50 Mumps virus, Jeryl-Lynn strain 19952TCID50 Rubella virus, Wistar RA27/3 strain 1000TCID50 Varicella vaccine 9772PFU |
| Dosage Form: | Powder for injection |
| Dosage Form: | Diluent |
| New Zealand Sponsor: | Merck Sharp & Dohme (New Zealand) Limited |
| Manufacturer: | Merck Sharp & Dohme LLC, Pennsylvania, United States of America |
| Product: | Varivax |
| Active Ingredient: | Varicella vaccine 1350PFU |
| Dosage Form: | Suspension for injection |
| Dosage Form: | Diluent |
| New Zealand Sponsor: | Merck Sharp & Dohme (New Zealand) Limited |
| Manufacturers: | Merck Sharp & Dohme LLC, Pennsylvania, United States of America Merck Sharp & Dohme LLC, North Carolina, United States of America |
Dated this 18th day of November 2025.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).