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: Antiseptic Soothing Cream
Active Ingredients: Bufexamac 50mg/g
Chlorhexidine gluconate 1mg/g
Lidocaine hydrochloride 10mg/g
Dosage Form: Topical cream
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Cipla Limited, Goa, India
Product: Cortimopt
Active Ingredients: Dorzolamide hydrochloride 22.26mg/mL equivalent to Dorzolamide 20 mg/mL
Timolol maleate 6.83mg/mL equivalent to Timolol 5 mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Wintac Limited, Karnataka, India
Product: Jaydess
Active Ingredient: Levonorgestrel 13.5mg
Dosage Form: Intrauterine contraceptive device
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturers: Bayer Oy, Turku, Finland
Sterigenics Belgium SA, Verviers, Belgium
Product: Metformin Mylan
Active Ingredient: Metformin hydrochloride 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturers: Alphapharm Pty Limited, Brisbane, Australia
Mylan Laboratories Limited, Maharashtra State, India
Product: Metformin Mylan
Active Ingredient: Metformin hydrochloride 850mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturers: Alphapharm Pty Limited, Brisbane, Australia
Mylan Laboratories Limited, Maharashtra State, India
Product: Molaxole
Active Ingredients: Macrogol 3350 13.125g
Potassium chloride 46.6mg
Sodium bicarbonate 178.5mg
Sodium chloride 350.7mg
Dosage Form: Powder for oral solution
New Zealand Sponsor: CARSL Consulting
Manufacturer: Recipharm Hoganas AB, Hoganas, Sweden
Product: Pravastatin Actavis
Active Ingredient: Pravastatin sodium 10mg
Dosage Form: Tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Product: Pravastatin Actavis
Active Ingredient: Pravastatin sodium 20mg
Dosage Form: Tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Product: Pravastatin Actavis
Active Ingredient: Pravastatin sodium 40mg
Dosage Form: Tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Dated this 4th day of July 2014.
STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).