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: Lodotra
Active Ingredient: Prednisone 1mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Mundipharma New Zealand Limited
Manufacturers: Aenova France S.A.S, Saint Quentin Fallavier Cedex, France
Bayer Pharma AG, Leverkusen, Germany
Product: Lodotra
Active Ingredient: Prednisone 2mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Mundipharma New Zealand Limited
Manufacturers: Aenova France S.A.S, Saint Quentin Fallavier Cedex, France
Bayer Pharma AG, Leverkusen, Germany
Product: Lodotra
Active Ingredient: Prednisone 5mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Mundipharma New Zealand Limited
Manufacturers: Aenova France S.A.S, Saint Quentin Fallavier Cedex, France
Bayer Pharma AG, Leverkusen, Germany
Product: Onglyza
Active Ingredient: Saxagliptin 2.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: Bristol-Myers Squibb Company, Indiana, United States of America
Product: Ranitidine Relief
Active Ingredient: Ranitidine hydrochloride 167.5mg equivalent to Ranitidine 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Adcock Ingram Limited - A Medreich Group Company, Karnataka, India
Product: Ranitidine Relief
Active Ingredient: Ranitidine hydrochloride 335mg equivalent to Ranitidine 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Adcock Ingram Limited - A Medreich Group Company, Karnataka, India
Product: Strepsils Children 6+ Orange
Active Ingredients: Amylmetacresol 0.6mg
Dichlorobenzyl alcohol 1.2mg
Dosage Form: Lozenge
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare International Limited, Nottingham, United Kingdom
Product: Strepsils Children 6+ Sugar Free Strawberry
Active Ingredients: Amylmetacresol 0.6mg
Dichlorobenzyl alcohol 1.2mg
Dosage Form: Lozenge
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare International Limited, Nottingham, United Kingdom
Dated this 13th day of September 2012.
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).