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: Macugen 300µg/dose
Active Ingredient: Pegaptanib sodium 3.47mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Gilead Sciences Inc, San Dimas, California, United States of America
Product: m-Amoxiclav
Active Ingredients: Amoxicillin sodium 1g
Potassium clavulanate 200mg
Dosage Form: Powder for injection
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Reig Jofre SA, Calle Jarama s/n, Toledo, Spain
Product: m-Amoxiclav
Active Ingredients: Amoxicillin sodium 500mg
Potassium clavulanate 100mg
Dosage Form: Powder for injection
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Reig Jofre SA, Calle Jarama s/n, Toledo, Spain
Product: Peptisoothe
Active Ingredient: Ranitidine hydrochloride 16.8mg/mL equivalent to ranitidine 15mg/mL
Dosage Form: Syrup
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland
Product: QV Flare Up Cream
Active Ingredients: Benzalkonium chloride 0.1%w/w
Glycerol 10%w/w
Light liquid paraffin 10%w/w
White soft paraffin 5%w/w
Dosage Form: Topical cream
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ego Pharmaceuticals Pty Limited, Braeside, Victoria, Australia
Product: Simdax
Active Ingredient: Levosimendan 2.5mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer: Fermion Oy, Espoo, Finland
Product: Sonaflam
Active Ingredient: Naproxen sodium 275mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Cipla Limited, Manufacturing Division, District Raigad, (Maharashtra), India
Dated this 27th day of April 2007.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).