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: Apo-Latanoprost
Active Ingredient: Latanoprost 50µg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Avigra
Active Ingredient: Sildenafil citrate 35.112mg equivalent to sildenafil 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Australia Pty Limited, West Ryde, Australia
Pfizer PGM, Poce Sur Cisse, France
Product: Avigra
Active Ingredient: Sildenafil citrate 70.225mg equivalent to sildenafil 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Australia Pty Limited, West Ryde, Australia
Pfizer PGM, Poce Sur Cisse, France
Product: Avigra
Active Ingredient: Sildenafil citrate 140.45mg equivalent to sildenafil 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Australia Pty Limited, West Ryde, Australia
Pfizer PGM, Poce Sur Cisse, France
Product: Ciclofast
Active Ingredient: Ciclopirox 80mg/g
Dosage Form: Nail lacquer
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturers: Alfa Wasserman SpA, Alanno, Italy
CPL Contract Pharmaceuticals Limited, Ontario, Canada
Product: Ciclopoli
Active Ingredient: Ciclopirox 80mg/g
Dosage Form: Nail lacquer
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturers: Alfa Wasserman SpA, Alanno, Italy
CPL Contract Pharmaceuticals Limited, Ontario, Canada
Product: Dianeal PD-4 Peritoneal Dialysis Solution with 1.5% w/v Glucose
Active Ingredients: Calcium chloride dihydrate 183mg/L
Glucose 15g/L
Magnesium chloride 50.8mg/L
Sodium chloride 5.38g/L
Sodium lactate 4.48g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter Healthcare Pty Limited, Old Toongabbie, Australia
Product: Dianeal PD-4 Peritoneal Dialysis Solution with 2.5% w/v Glucose
Active Ingredients: Calcium chloride dihydrate 183mg/L
Glucose 25g/L
Magnesium chloride 50.8mg/L
Sodium chloride 5.38g/L
Sodium lactate 4.48g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter Healthcare Pty Limited, Old Toongabbie, Australia
Product: Dianeal PD-4 Peritoneal Dialysis Solution with 4.25% w/v Glucose
Active Ingredients: Calcium chloride dihydrate 183mg/L
Glucose 42.5g/L
Magnesium chloride 50.8mg/L
Sodium chloride 5.38g/L
Sodium lactate 4.48g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter Healthcare Pty Limited, Old Toongabbie, Australia
Product: Panzop Relief (Restricted)
Active Ingredient: Pantoprazole sodium sesquihydrate 22.55mg equivalent to pantoprazole 20mg
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Nashik, India
Product: Panzop Relief (Prescription)
Active Ingredient: Pantoprazole sodium sesquihydrate 22.55mg equivalent to pantoprazole 20mg
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Nashik, India
Product: Panzop Relief
Active Ingredient: Pantoprazole sodium sesquihydrate 45.1mg equivalent to pantoprazole 40mg
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Nashik, India
Product: Pramipexole Hydrochloride
Active Ingredient: Pramipexole hydrochloride 0.25mg equivalent to pramipexole 0.18mg
Dosage Form: Tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Bachupally, India
Product: Pramipexole Hydrochloride
Active Ingredient: Pramipexole hydrochloride 0.125mg equivalent to pramipexole 0.088mg
Dosage Form: Tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Bachupally, India
Product: Pramipexole Hydrochloride
Active Ingredient: Pramipexole hydrochloride 0.5mg equivalent to pramipexole 0.35mg
Dosage Form: Tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Bachupally, India
Product: Pramipexole Hydrochloride
Active Ingredient: Pramipexole hydrochloride 1mg equivalent to pramipexole 0.7mg
Dosage Form: Tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Bachupally, India
Product: Revolade
Active Ingredient: Eltrombopag olamine 31.9mg equivalent to eltrombopag 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Glaxo Operations UK Limited (t/a Glaxo Wellcome Operations), Hertfordshire, United Kingdom
Product: Revolade
Active Ingredient: Eltrombopag olamine 63.8mg equivalent to eltrombopag 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Glaxo Operations UK Limited (t/a Glaxo Wellcome Operations), Hertfordshire, United Kingdom
Dated this 17th day of February 2011.
BARBARA PHILLIPS, Acting Deputy Director-General, Population Health Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).