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: Atorvastatin Tablets
Active Ingredient: Atorvastatin calcium 10.34mg equivalent to atorvastatin 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Atorvastatin Tablets
Active Ingredient: Atorvastatin calcium 20.68mg equivalent to atorvastatin 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Atorvastatin Tablets
Active Ingredient: Atorvastatin calcium 41.36mg equivalent to atorvastatin 40mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Atorvastatin Tablets
Active Ingredient: Atorvastatin calcium 82.73mg equivalent to atorvastatin 80mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Auro-Quetiapine 25
Active Ingredient: Quetiapine fumarate 28.78mg equivalent to quetiapine 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Hyderabad, India
Product: Auro-Quetiapine 100
Active Ingredient: Quetiapine fumarate 115.122mg equivalent to quetiapine 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Hyderabad, India
Product: Auro-Quetiapine 150
Active Ingredient: Quetiapine fumarate 172.683mg equivalent to quetiapine 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Hyderabad, India
Product: Auro-Quetiapine 200
Active Ingredient: Quetiapine fumarate 230.244mg equivalent to quetiapine 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Hyderabad, India
Product: Auro-Quetiapine 300
Active Ingredient: Quetiapine fumarate 345.366mg equivalent to quetiapine 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Hyderabad, India
Product: Ava 30
Active Ingredients: Ethinylestradiol 0.0306mg
Levonorgestrel 0.15mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Famy Care Limited, Gujarat, India
Product: Daivobet 50/500 gel
Active Ingredients: Betamethasone dipropionate 0.5mg/g
Calcipotriol 50µg/g
Dosage Form: Topical gel
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: LEO Pharma A/S, Ballerup, Denmark
Product: Juvederm ULTRA PLUS XC
Active Ingredients: Hyaluronic acid 24mg/mL
Lidocaine hydrochloride, anhydrous 3mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Allergan New Zealand Limited
Manufacturer: Allergan France, Pringy, France
Product: Juvederm ULTRA XC
Active Ingredients: Hyaluronic acid 24mg/mL
Lidocaine hydrochloride, anhydrous 3mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Allergan New Zealand Limited
Manufacturer: Allergan France, Pringy, France
Product: Juvederm VOLUMA XC
Active Ingredients: Hyaluronic acid 20mg/mL
Lidocaine 3mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Allergan New Zealand Limited
Manufacturer: Allergan France, Pringy, France
Product: Oralcon 30
Active Ingredients: Ethinylestradiol 0.0306mg
Levonorgestrel 0.15mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Famy Care Limited, Gujarat, India
Product: Oralcon 30 ED
Active Ingredients: Ethinylestradiol 0.0306mg
Levonorgestrel 0.15mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Famy Care Limited, Gujarat, India
Product: Quetiapine Pfizer
Active Ingredient: Quetiapine fumarate 28.78mg equivalent to quetiapine 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Hyderabad, India
Product: Quetiapine Pfizer
Active Ingredient: Quetiapine fumarate 115.122mg equivalent to quetiapine 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Hyderabad, India
Product: Quetiapine Pfizer
Active Ingredient: Quetiapine fumarate 172.683mg equivalent to quetiapine 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Hyderabad, India
Product: Quetiapine Pfizer
Active Ingredient: Quetiapine fumarate 230.244mg equivalent to quetiapine 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Hyderabad, India
Product: Quetiapine Pfizer
Active Ingredient: Quetiapine fumarate 345.366mg equivalent to quetiapine 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Hyderabad, India
Dated this 7th day of July 2011.
STEWART JESSAMINE, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).