Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the Schedule hereto:
Schedule
Product: Ferriprox
Active Ingredient: Deferiprone 100mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Apotex Inc, Richmond Hill Site, Richmond Hill, Ontario, Canada
Product: Ferriprox
Active Ingredient: Deferiprone 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Apotex Inc, Etobicoke, Ontario, Canada
Product: Gaviscon Dual Action
Active Ingredients: Calcium carbonate 187.5mg
Sodium alginate 250mg
Sodium bicarbonate 106.5mg
Dosage Form: Chewable tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare (UK) Limited, Hull, North Humberside, United Kingdom
Product: Lucrin Depot 1-Month
Active Ingredient: Leuprorelin acetate 3.75mg
Dosage Form: Injection (depot)
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturers: Takeda Pharmaceutical Company Limited, Hikari-city, Yamaguchi, Japan
Takeda Pharmaceutical Company Limited, Yodogawa-ku, Osaka, Japan
Product: Lucrin Depot 3-Month
Active Ingredient: Leuprorelin acetate 11.25mg
Dosage Form: Injection (depot)
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturers: Takeda Pharmaceutical Company Limited, Hikari-city, Yamaguchi, Japan
Takeda Pharmaceutical Company Limited, Yodogawa-ku, Osaka, Japan
Product: Lucrin Depot 6-month
Active Ingredient: Leuprorelin acetate 30mg
Dosage Form: Injection (depot)
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturers: Takeda Pharmaceutical Company Limited, Hikari-city, Yamaguchi, Japan
Takeda Pharmaceutical Company Limited, Osaka Plant, Yodogawa-ku, Osaka, Japan
Product: Meridia
Active Ingredient: Sibutramine hydrochloride monohydrate 10mg
Dosage Form: Capsule
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer: Abbott GmbH & Co. KG, Ludwigshafen, Germany
Product: Meridia
Active Ingredient: Sibutramine hydrochloride monohydrate 15mg
Dosage Form: Capsule
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer: Abbott GmbH & Co. KG, Ludwigshafen, Germany
Product: SOOV IT for Haemorrhoids
Active Ingredients: Hydrocortisone 0.5%w/w
Lidocaine 5%w/w
Dosage Form: Rectal ointment
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ego Pharmaceuticals Pty Limited, Braeside, Victoria, Australia
Product: Synflorix
Active Ingredients: Pneumococcal Polysaccharide type 1 1µg
Pneumococcal Polysaccharide type 14 1µg
Pneumococcal Polysaccharide type 18C 3µg
Pneumococcal Polysaccharide type 19F 3µg
Pneumococcal Polysaccharide type 23F 1µg
Pneumococcal Polysaccharide type 4 3µg
Pneumococcal Polysaccharide type 5 1µg
Pneumococcal Polysaccharide type 6B 1µg
Pneumococcal Polysaccharide type 7F 1µg
Pneumococcal Polysaccharide type 9V 1µg
Dosage Form: Suspension for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: GlaxoSmithKline Biologicals SA, Parc de la Noire Epine, Wavre, Belgium
GlaxoSmithKline Biologicals SA, Rixensart, Belgium
Dated this 15th 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).