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: Arrow-Diazepam 2
Active Ingredient: Diazepam 2mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Sigma Pharmaceuticals Australia Pty Limited, Baulkham Hills, NSW, Australia
Product: Arrow-Diazepam 5
Active Ingredient: Diazepam 5mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Sigma Pharmaceuticals Australia Pty Limited, Baulkham Hills, NSW, Australia
Product: Children’s Claratyne
Active Ingredient: Loratadine 1mg/mL
Dosage Form: Syrup
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Schering Corporation (USA), Kenilworth, New Jersey, United States of America
Product: Cold & Flu Relief
Active Ingredients: Paracetamol 500mg
Phenylephrine hydrochloride 5mg equivalent to 4.1mg phenylephrine
Dosage Form: Tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Matrix Laboratories Limited, Sinnar, Nashik, Maharashta, India
Product: Demazin Decongestant Nasal Spray Metered Pump
Active Ingredient: Oxymetazoline hydrochloride 0.5mg/mL
Dosage Form: Nasal spray solution
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Schering-Plough Mexico SA De CV, Xaltocan Xochimilco, Mexico
Product: Demazin Decongestant Nasal Spray
Active Ingredient: Oxymetazoline hydrochloride 0.5mg/mL
Dosage Form: Nasal spray solution
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Schering-Plough Mexico SA De CV, Xaltocan Xochimilco, Mexico
Product: Drixine Decongestant Nasal Spray
Active Ingredient: Oxymetazoline hydrochloride 0.5mg/mL
Dosage Form: Nasal spray solution
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Schering-Plough Mexico SA De CV, Xaltocan Xochimilco, Mexico
Product: Drixine Metered Pump Decongestant Nasal Spray
Active Ingredient: Oxymetazoline hydrochloride 0.5mg/mL
Dosage Form: Nasal spray solution
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Schering-Plough Mexico SA De CV, Xaltocan Xochimilco, Mexico
Product: Duro-Tuss Chesty Forte Cough Liquid
Active Ingredients: Bromhexine hydrochloride 0.8mg/mL
Guaifenesin 20mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturer: Probiotec Pharma Pty Limited, Laverton North, Victoria, Australia
Product: Galvus Met
Active Ingredients: Metformin hydrochloride 1,000mg
Vildagliptin 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Galvus Met
Active Ingredients: Metformin hydrochloride 850mg
Vildagliptin 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: NovoSeven RT
Active Ingredient: Factor VIIa, recombinant human 1mg
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Gentofte, Denmark
Product: NovoSeven RT
Active Ingredient: Factor VIIa, recombinant human 2mg
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Gentofte, Denmark
Product: NovoSeven RT
Active Ingredient: Factor VIIa, recombinant human 5mg
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Gentofte, Denmark
Product: Sinus Relief
Active Ingredient: Phenylephrine hydrochloride 10mg equivalent to 8.2mg phenylephrine
Dosage Form: Tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Matrix Laboratories Limited, Sinnar, Nashik, Maharashta, India
Product: Sinutab PE Phenylephrine Sinus & Pain Relief
Active Ingredients: Paracetamol 500mg
Phenylephrine hydrochloride 5mg equivalent to 4.1mg phenylephrine
Dosage Form: Tablet
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Pfizer Laboratories (Pty) Limited, Retreat, Cape Town, South Africa
Product: Sinutab PE Phenylephrine Sinus, Allergy & Pain Relief
Active Ingredients: Chlorphenamine maleate 2mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg equivalent to 4.1mg phenylephrine
Dosage Form: Tablet
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Pfizer Laboratories (Pty) Limited, 241 Main Road, Retreat, Cape Town, South Africa
Product: Sinutab Sinus & Pain Relief
Active Ingredients: Paracetamol 500mg
Pseudoephedrine hydrochloride 30mg
Dosage Form: Tablet
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer Johnson & Johnson Pty Limited, Retreat, Cape Town, South Africa
Product: Zavesca
Active Ingredient: Miglustat 100mg
Dosage Form: Capsule
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Almac Pharma Services Limited, Craigavon County, Armagh, Ireland
Dated this 8th day of May 2009.
MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).