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: Hyprosol
Active Ingredient: Hypromellose 0.03g
Dosage Form: Eye drops, solution
New Zealand Sponsor: Beximco Pharmaceuticals New Zealand Limited
Manufacturer: Beximco Pharmaceuticals Limited, Gazipur, Bangladesh
Product: Meropenem Alphapharm
Active Ingredient: Meropenem trihydrate 570.4mg equivalent to Meropenem anhydrous 500mg
Dosage Form: Powder for injection
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: LDP Laboratorios Torlan S.A, Barcelona, Spain
Product: Meropenem Alphapharm
Active Ingredient: Meropenem trihydrate 1140.8mg equivalent to Meropenem anhydrous 1000mg
Dosage Form: Powder for injection
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: LDP Laboratorios Torlan S.A, Barcelona, Spain
Product: Volulyte 6%
Active Ingredients: Hydroxyethyl starch 130/0.4 60g/L
Magnesium chloride hexahydrate 0.3g/L
Potassium chloride 0.3g/L
Sodium acetate trihydrate 4.63g/L
Sodium chloride 6.02g/L
Dosage Form: Solution for infusion
New Zealand Sponsor: Fresenius Kabi New Zealand Limited
Manufacturers: Fresenius Kabi Deutschland GmbH, Friedberg, Germany
Fresenius Kabi France, Louviers, France
Product: Xgeva
Active Ingredient: Denosumab 120mg
Dosage Form: Solution for injection
New Zealand Sponsor: Amgen New Zealand Limited
Manufacturer: Amgen Manufacturing Limited, Juncos, Puerto Rico
Product: Zoely
Active Ingredients: Estradiol hemihydrate 1.55mg equivalent to Estradiol 1.5mg
Nomegestrol acetate 2.5mg
Dosage Form: Active Tablet
Dosage Form: Placebo Tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: NV Organon, Oss, The Netherlands
Organon (Ireland) Limited, County Dublin, Ireland
Dated this 26th day of April 2012.
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).