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: Empliciti
Active Ingredient: Dapagliflozin propanediol 12.3mg equivalent to dapaglifozin 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturers: Bristol-Myers Squibb Manufacturing Company, Humacao, Puerto Rico
Bristol-Myers Squibb Company, Indiana, United States of America
Product: Juvicor
Active Ingredients: Simvastatin 10mg
Sitagliptin phosphate monohydrate 128.5mg equivalent to sitagliptin 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: MSD International GmbH (Ireland), County Tipperary, Ireland
Merck Sharp & Dohme Limited, Northumberland, United Kingdom
Product: Juvicor
Active Ingredients: Simvastatin 20mg
Sitagliptin phosphate monohydrate 128.5mg equivalent to sitagliptin 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: MSD International GmbH (Ireland), County Tipperary, Ireland
Merck Sharp & Dohme Limited, Northumberland, United Kingdom
Product: Juvicor
Active Ingredients: Simvastatin 40mg
Sitagliptin phosphate monohydrate 128.5mg equivalent to sitagliptin 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: MSD International GmbH (Ireland), County Tipperary, Ireland
Merck Sharp & Dohme Limited, Northumberland, United Kingdom
Product: Oxytocin BNM
Active Ingredient: Oxytocin 5IU/mL equivalent to 8.3mcg/ml
Dosage Form: Solution for injection
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturer: Rotexmedica GmbH, Trittau, Germany
Product: Oxytocin BNM
Active Ingredient: Oxytocin 10IU/mL equivalent to 16.6mcg/ml
Dosage Form: Solution for injection
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturer: Rotexmedica GmbH, Trittau, Germany
Dated this 29th day of May 2013.
DR 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).