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: Axiron
Active Ingredient: Testosterone 2%w/v
Dosage Form: Topical solution
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: Orion Corporation, Turku, Finland
Product: HydralyteT Apple Blackcurrant Effervescent Electrolyte Tablets
Active Ingredients: Citric acid 672mg
Glucose 1620mg
Potassium chloride 149mg
Sodium bicarbonate 378mg
Sodium chloride 87.5mg
Dosage Form: Effervescent tablet
New Zealand Sponsor: Hydration Pharmaceuticals Pty Limited
Manufacturer: Alpex Pharma SA, Mezzovico, Switzerland
Product: HydralyteT Orange Effervescent Electrolyte Tablets
Active Ingredients: Citric acid 672mg
Glucose 1620mg
Potassium chloride 149mg
Sodium bicarbonate 378mg
Sodium chloride 87.5mg
Dosage Form: Effervescent tablet
New Zealand Sponsor: Hydration Pharmaceuticals Pty Limited
Manufacturer: Alpex Pharma SA, Mezzovico, Switzerland
Product: Imatinib-AFT
Active Ingredient: Imatinib mesilate 477.88mg equivalent to Imatinib 400mg
Dosage Form: Capsule
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pabianickie Zaklady Farmaceutyczne Polfa SA, Pabianice, Poland
Product: Imatinib-AFT
Active Ingredient: Imatinib mesilate 119.47mg equivalent to Imatinib 100mg
Dosage Form: Capsule
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pabianickie Zaklady Farmaceutyczne Polfa SA, Pabianice, Poland
Product: MeniCare Plus
Active Ingredients: Baquacil 0.0005%w/v
Poloxamer 407 0.5%w/v
Dosage Form: Contact lens solution
New Zealand Sponsor: Corneal Lens Corporation NZ Limited
Manufacturer: Menicon Pharma SAS, Illkirch Graffenstaden, France
Product: Progent
Solution A
Active Ingredient: Sodium hypochlorite 0.406mg/mL
Dosage Form: Contact lens solution
Solution B
Active Ingredient: Potassium bromide 0.615%w/v
Dosage Form: Contact lens solution
New Zealand Sponsor: Corneal Lens Corporation NZ Limited
Manufacturer: Menicon Pharma SAS, Illkirch Graffenstaden, France
Product: Seebri Breezhaler
Active Ingredient: Glycopyrronium bromide 0.063mg equivalent to Glycopyrronium 0.05mg
Dosage Form: Powder filled inhalation capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Pharma Stein AG, Stein, Switzerland
Novartis Pharma Schweizerhalle AG, Schweizerhalle, Switzerland
Dated this 5th day of September 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).