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: Hycamtin
Active Ingredient: Topotecan hydrochloride 0.27mg equivalent to 0.25mg topotecan
Dosage Form: Capsule
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Manufacturing SpA, Parma, Italy
Product: Hycamtin
Active Ingredient: Topotecan hydrochloride 1.09mg equivalent to 1mg topotecan
Dosage Form: Capsule
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Manufacturing SpA, Parma, Italy
Product: Listerine Smooth Mint antiseptic mouthwash
Active Ingredients: Benzoic acid 1.2mg/mL
Cineole 0.922mg/mL
Ethanol 0.225mL/mL
Thymol 0.639mg/mL
Dosage Form: Mouthwash
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: McNeil Manufacturing Pty Limited, Caringbah, Australia
Product: Panadol Rapid
Active Ingredient: Paracetamol 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Dungarvan Limited, Waterford, Ireland
Product: Prevenar 13
Active Ingredients: Diphtheria CRM 197 protein conjugate 32µg
Pneumococcal polysaccharide serotype 6A 2.2µg
Pneumococcal Polysaccharide type 1 2.2µg
Pneumococcal Polysaccharide type 14 2.2µg
Pneumococcal Polysaccharide type 18C 2.2µg
Pneumococcal Polysaccharide type 19A 2.2µg
Pneumococcal Polysaccharide type 19F 2.2µg
Pneumococcal Polysaccharide type 23F 2.2µg
Pneumococcal Polysaccharide type 3 2.2µg
Pneumococcal Polysaccharide type 4 2.2µg
Pneumococcal Polysaccharide type 5 2.2µg
Pneumococcal Polysaccharide type 6B 4.4µg
Pneumococcal Polysaccharide type 7F 2.2µg
Pneumococcal Polysaccharide type 9V 2.2µg
Dosage Form: Suspension for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturers: Wyeth Pharmaceuticals Inc, New York, United States of America
Baxter BioPharma Solutions LLC, Bloomington, United States of America
Product: ReGen
Active Ingredient: Finasteride 1mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Biofarma Pharmaceutical Industry Co. Inc., Istanbul, Turkey
Product: Serdolect
Active Ingredient: Sertindole 4mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: H Lundbeck A/S, Valby, Denmark
Product: Serdolect
Active Ingredient: Sertindole 12mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: H Lundbeck A/S, Valby, Denmark
Product: Serdolect
Active Ingredient: Sertindole 16mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: H Lundbeck A/S, Valby, Denmark
Product: Serdolect
Active Ingredient: Sertindole 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: H Lundbeck A/S, Valby, Denmark
Dated this 18th day of March 2010.
MARK RICHARDS, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health 6 July 2001).