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: Abbapram
Active Ingredient: Citalopram hydrobromide 24.98mg equivalent to 20mg citalopram
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturers: H Lundbeck A/S, Valby, Denmark
Patheon France S.A., Bourgoin-Jallieu, France
Product: Asamax 500
Active Ingredient: Mesalazine 500mg
Dosage Form: Suppository
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: Temmler Italia S.r.l., Carugate (MI), Italy
Product: Durotram XR
Active Ingredient: Tramadol hydrochloride 100mg
Dosage Form: Modified release tablet
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturer: Laboratoires Confab Inc., St Hubert, Quebec, Canada
Product: Durotram XR
Active Ingredient: Tramadol hydrochloride 200mg
Dosage Form: Modified release tablet
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturer: Laboratoires Confab Inc., St Hubert, Quebec, Canada
Product: Durotram XR
Active Ingredient: Tramadol hydrochloride 300mg
Dosage Form: Modified release tablet
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturer: Laboratoires Confab Inc., St Hubert, Quebec, Canada
Product: Kaletra
Active Ingredients: Lopinavir 100mg
Ritonavir 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer: Abbott GmbH & Co. KG, Ludwigshafen, Germany
Product: Norvapine
Active Ingredient: Amlodipine besilate 13.889mg equivalent to 10mg amlodipine
Dosage Form: Tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Australia Pty Limited, New South Wales, Australia
Pfizer Pharmaceuticals Limited, Economic and Technical, Dalian, China
Product: Norvapine
Active Ingredient: Amlodipine besilate 6.944mg equivalent to 5mg amlodipine
Dosage Form: Tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Australia Pty Limited, West Ryde, New South Wales, Australia
Pfizer Pharmaceuticals Limited, Economic and Technical, Dalian, China
Product: Pantocid I.V.
Active Ingredient: Pantoprazole sodium sesquihydrate 45.12mg equivalent to pantroprazole 40.0mg
Dosage Form: Powder for injection
New Zealand Sponsor: PSM Healthcare Limited trading as API Consumer Brands
Manufacturer: Sun Pharmaceutical Industries Limited, Halol, Gujarat, India
Product: Temodal
Active Ingredient: Temozolomide 140mg
Dosage Form: Capsule
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Orion Pharma, Turku, Finland
Product: Temodal
Active Ingredient: Temozolomide 180mg
Dosage Form: Capsule
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Orion Pharma, Turku, Finland
Dated this 26th day of September 2008.
MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).