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: Atenolol tablets USP (Mylan)
Active Ingredient: Atenolol 50mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Pharmaceuticals Inc, West Virginia, United States of America
Product: Atenolol tablets USP (Mylan)
Active Ingredient: Atenolol 100mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Pharmaceuticals Inc, West Virginia, United States of America
Product: Dobutamine-hameln 12.5 mg/mL concentrate for solution for infusion
Active Ingredient: Dobutamine hydrochloride 14mg/mL equivalent to dobutamine 12.5mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Max Health Limited
Manufacturer: Hameln Pharmaceuticals GmbH, Hameln, Germany
Product: Herclon
Active Ingredient: Trastuzumab 150mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: Roche Diagnostics GmbH, Mannheim, Germany
F Hoffmann-La Roche Limited, Basel, Switzerland
Product: Herclon
Active Ingredient: Trastuzumab 440mg
Dosage Form: Powder for infusion with diluent
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: F Hoffmann-La Roche Limited, Basel, Switzerland
Genentech Inc, California, United States of America
Product: TOBI Podhaler
Active Ingredient: Tobramycin 28mg
Dosage Form: Powder filled inhalation capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharmaceuticals Corporation, California, United States of America
Dated this 7th day of August 2013.
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).