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: Eligard 6 Month
Active Ingredient: Leuprorelin acetate 45mg/mL
Dosage Forms: Powder for injection
Diluent
New Zealand Sponsor: Mayne Pharma Limited
Manufacturer: QLT USA, Inc, Fort Collins, Colorado, United States of America
Product: Klamycin Hp7 (Combination Product)
Active Ingredient: Clarithromycin 500mg
Dosage Form: Film coated tablet
Manufacturer: Genpharm Inc., Etobicoke, Ontario, Canada
Active Ingredient: Amoxicillin trihydrate 575mg equivalent to amoxycillin 500mg
Dosage Form: Capsule
Manufacturer: Pacific Pharmaceuticals Limited, Mt Wellington, Auckland
Active Ingredient: Omeprazole 20mg
Dosage Form: Modified release capsule
Manufacturer: Laboratorios Dr. Esteve SA, Poligon Industrial, Santa Marti, Martorelles, Barcelona, Spain
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Product: Voltfast
Active Ingredient: Diclofenac potassium 50mg
Dosage Form: Powder for oral solution
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturer: Mipharm SpA, Milano, Italy
Dated this 4th day of August 2006.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).