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: | 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: | Aesica Queenborough Limited, Queenborough, United Kingdom Patheon Pharmaceuticals Inc, Ohio, United States of America |
| Product: | Nimenrix |
| Active Ingredients: | Neisseria meningitidis Group A polysaccharide, tetanus toxoid conjugate 5mcg Neisseria meningitidis Group C polysaccharide, tetanus toxoid conjugate 5mcg Neisseria meningitidis Group W135 polysaccharide, tetanus toxoid conjugate 5mcg Neisseria meningitidis Group Y polysaccharide, tetanus toxoid conjugate 5mcg |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturers: | GlaxoSmithKline Biologicals SA (Wave Nord), Wavre, Belgium Pfizer Manufacturing Belgium NV, Puurs-Sint-Amands, Belgium |
| Product: | Xolair (75mg/0.5mL) |
| Active Ingredient: | Omalizumab 150mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany |
| Product: | Xolair (150mg/1mL) |
| Active Ingredient: | Omalizumab 150mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany |
Dated this 22nd day of March 2024.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).