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: Cialis
Active Ingredient: Tadalafil 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: Eli Lilly and Co, Lilly Indianapolis, Indiana, United States of America
Product: Cialis
Active Ingredient: Tadalafil 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: Eli Lilly and Co, Lilly Indianapolis, Indiana, United States of America
Product: Fortovase
Active Ingredient: Saquinavir 200mg
Dosage Form: Liquid filled soft gelatin capsule
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: R P Scherer & Co. KG., Eberbach/Baden, Germany
Product: Invirase
Active Ingredient: Saquinavir mesilate 228.7mg equivalent to 200mg Saquinavir free base
Dosage Form: Capsule
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: F Hoffmann-La Roche AG, Basel, Switzerland
Hoffmann-La Roche Inc, Nutley, New Jersey, United States of America
Product: Pam's Paracetamol Tablets
Active Ingredient: Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: REX Medical Limited
Manufacturers: Cipla Limited, Patalganga, District Raigad, (Maharashtra), India
Cipla Limited, Kurkumbh Village, Taluka - Daund, District - Pune (Maharashtra), India
Product: Prevenar
Active Ingredients: Diphtheria CRM 197 protein conjugate 20Ág
Pneumococcal Polysaccharide type 14 2Ág/dose
Pneumococcal Polysaccharide type 18C 2Ág/dose
Pneumococcal Polysaccharide type 19F 2Ág/dose
Pneumococcal Polysaccharide type 23F 2Ág/dose
Pneumococcal Polysaccharide type 4 2Ág/dose
Pneumococcal Polysaccharide type 6B 4Ág/dose
Pneumococcal Polysaccharide type 9V 2Ág/dose
Dosage Form: Suspension for injection
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer: Wyeth Lederle Vaccines, Pearl River, New York, United States of America
Dated this 7th day of November 2002.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).