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: | Cerezyme |
| Active Ingredient: | Imiglucerase 400U |
| Dosage Form: | Powder for infusion |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Genzyme Ireland Limited, Waterford, Ireland |
| Product: | Hexaxim |
| Active Ingredients: | Diphtheria toxoid, adsorbed 30Lf U equivalent to not less than 20IU Haemophilus influenzae type b polysaccharide 12mcg Hepatitis B virus surface antigen 10mcg Pertussis filamentous haemagglutinin 25mcg Pertussis toxoid, adsorbed 25mcg Polio virus type 1 40DAgU Polio virus type 2 8DAgU Polio virus type 3 32DAgU Tetanus toxoid, adsorbed 10Lf U equivalent to not less than 40IU |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Sanofi Pasteur SA, Val-De-Reuil Cedex, France |
| Product: | Minirin |
| Active Ingredient: | Desmopressin acetate trihydrate 4mcg/mL equivalent to desmopressin 3.56mcg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pharmaco (NZ) Limited |
| Manufacturers: | Ferring GmbH, Kiel, Germany Rechon Life Science AB, Limhamn, Sweden |
| Product: | Octostim |
| Active Ingredient: | Desmopressin acetate trihydrate 15mcg/mL equivalent to desmopressin 13.4mcg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pharmaco (NZ) Limited |
| Manufacturers: | Ferring GmbH, Kiel, Germany Rechon Life Science AB, Limhamn, Sweden |
| Product: | Parecoxib Juno |
| Active Ingredient: | Parecoxib sodium 42.36mg equivalent to parecoxib 40mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Juno Pharmaceuticals NZ Limited |
| Manufacturers: | Anfarm Hellas SA, Schimatari, Greece Gufic Biosciences Limited, Navsari, India |
| Product: | Trileptal |
| Active Ingredient: | Oxcarbazepine 150mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Novartis Pharma Stein AG, Stein, Switzerland Novartis Farma SpA, Torre Annunziata, Italy |
| Product: | Trileptal |
| Active Ingredient: | Oxcarbazepine 600mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Novartis Pharma Stein AG, Stein, Switzerland Novartis Farma SpA, Torre Annunziata, Italy |
| Product: | Vfend |
| Active Ingredient: | Voriconazole 40mg/mL |
| Dosage Form: | Powder for oral suspension |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Fareva Amboise, Poce Sur Cisse, France |
| Product: | Vfend |
| Active Ingredient: | Voriconazole 50mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturers: | Pfizer Italia SrL, Ascoli Piceno, Italy R-Pharm Germany GmbH, Illertissen, Germany |
| Product: | Vfend |
| Active Ingredient: | Voriconazole 200mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pharmacia & Upjohn Company LLC, Michigan, United States of America |
| Product: | Vfend |
| Active Ingredient: | Voriconazole 200mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturers: | Pfizer Italia SrL, Ascoli Piceno, Italy R-Pharm Germany GmbH, Illertissen, Germany |
Dated this 20th day of September 2024.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).