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: Codalgin
Active Ingredients: Codeine phosphate hemihydrate 8mg
Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Aspen Pharma Pty Limited, Dandenong, Australia
Product: Maximum Strength Mucinex (General Sale)
Active Ingredient: Guaifenesin 1200mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturers: Catalent Pharma Solutions LLC, Kentucky, United States of America
Reckitt Benckiser Healthcare International Limited, Nottinghamshire, United Kingdom
Reckitt Benckiser LLC, Texas, United States of America
Product: Maximum Strength Mucinex (Restricted)
Active Ingredient: Guaifenesin 1200mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturers: Catalent Pharma Solutions LLC, Kentucky, United States of America
Reckitt Benckiser Healthcare International Limited, Nottinghamshire, United Kingdom
Reckitt Benckiser LLC, Texas, United States of America
Product: Menopur
Active Ingredient: Menotrophin 75IU equivalent to 75IU FSH and 75IU LH
Dosage Form: Powder for injection
New Zealand Sponsor: Medconsult Services Limited
Manufacturers: Ferring GmbH, Kiel, Germany
Rentschler Biotechnologie GmbH, Laupheim, Germany
Product: Nitrosol
Active Ingredient: Glyceryl trinitrate 8.32mg/mL
Dosage Form: Oral spray
New Zealand Sponsor: Beximco Pharmaceuticals New Zealand Limited
Manufacturer: Beximco Pharmaceuticals Limited, Gazipur, Bangladesh
Dated this 29th day of September 2011.
DR DON MACKIE, 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).