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 set out in the Schedule hereto:
Schedule
Product: Apo-Celecoxib
Active Ingredient: Celecoxib 100mg
Dosage Form: Capsule
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Celecoxib
Active Ingredient: Celecoxib 200mg
Dosage Form: Capsule
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Imatinib
Active Ingredient: Imatinib mesilate 119.5mg equivalent to Imatinib 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Imatinib
Active Ingredient: Imatinib mesilate 478mg equivalent to Imatinib 400mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Dobutamine-Claris
Active Ingredient: Dobutamine hydrochloride 14.01mg/mL equivalent to Dobutamine 12.5mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Claris Life Sciences Limited, Gujarat, India
Product: Hydralyte Colour Free Lemonade Flavoured Electrolyte Ice Blocks
Active Ingredients: Citric acid monohydrate 4.8mg/mL
Glucose monohydrate 16mg/mL
Potassium citrate monohydrate 2.2mg/mL
Sodium chloride 2.5mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: The Hydration Pharmaceutical Trust, Sydney, Australia
Product: Hydralyte Ready to use Colour Free Lemonade Flavoured Electrolyte Solution
Active Ingredients: Citric acid monohydrate 4.8mg/mL
Glucose monohydrate 16mg/mL
Potassium citrate monohydrate 2.213mg/mL
Sodium chloride 2.528mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: The Hydration Pharmaceutical Trust, Sydney, Australia
Product: Prezista
Active Ingredient: Darunavir ethanolate 867.28mg equivalent to Darunavir 800mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen Ortho LLC, Gurabo, Puerto Rico
Product: Vitekta
Active Ingredient: Elvitegravir 85mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Gilead Sciences (NZ)
Manufacturer: Patheon Inc, Ontario, Canada
Product: Vitekta
Active Ingredient: Elvitegravir 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Gilead Sciences (NZ)
Manufacturer: Patheon Inc, Ontario, Canada
Dated this 3rd day of October 2014.
STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).