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: Acetadote
Active Ingredient: Acetylcysteine 206mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Bioniche Teoranta, Inverin, Ireland
Product: NuvaRing
Active Ingredients: Ethinylestradiol 2.7mg
Etonogestrel 11.7mg
Dosage Form: Vaginal ring
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: NV Organon, Oss, The Netherlands
Product: Oxaliccord
Active Ingredient: Oxaliplatin 5mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Ahmedabad, India
Product: Pergoveris
Active Ingredients: Follitropin alfa 150IU
Lutropin alfa, rch 75IU
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Merck Serono SA, Aubonne, Switzerland
Product: Pregnosis Early Pregnancy Test
Active Ingredients: Goat anti-hCG polyclonal antibody 0.00132mg
Goat anti-mouse immunoglobulin G polyclonal antibody 0.000352mg
Immunoglobulin G 0.000055mg
Murine anti-beta-hCG monoclonal antibody-colloidal gold conjugate 0.001778mg
Dosage Form: Pregnancy test kit
New Zealand Sponsor: Wilson Foods Limited
Manufacturer: Abon Biopharm (Hangzhou) Co. Limited, Hangzhou, China
Product: Promethazine Winthrop
Active Ingredient: Promethazine hydrochloride 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi Aventis SA, Madrid, Spain
Product: Promethazine Winthrop
Active Ingredient: Promethazine hydrochloride 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi Aventis SA, Madrid, Spain
Product: Stelara
Active Ingredient: Ustekinumab 45mg
Dosage Form: Solution for injection
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Cilag AG, Schaffhausen, Switzerland
Product: Stelara
Active Ingredient: Ustekinumab 90mg
Dosage Form: Solution for injection
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Cilag AG, Schaffhausen, Switzerland
Product: Suvacid Heartburn Relief
Active Ingredient: Pantoprazole sodium sesquihydrate 22.55mg equivalent to 20mg pantoprazole
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Sandoz Ilac Sanayi ve Ticaret Anonim Sirketi, Gebze, Turkey
Product: Ursofalk
Active Ingredient: Ursodeoxycholic acid 250mg
Dosage Form: Capsule
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Losan Pharma GmbH, Neuenburg, Germany
Dated this 22nd day of September 2010.
JANICE WILSON, Deputy Director-General, Population Health Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).