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: Carbaccord
Active Ingredient: Carboplatin 10mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Ahmedabad, India
Product: Dapsone
Active Ingredient: Dapsone 25mg
Dosage Form: Tablet
New Zealand Sponsor: Link Pharmaceuticals Limited
Manufacturer: Jacobus Pharmaceutical Company Inc, New Jersey, United States of America
Product: Dapsone
Active Ingredient: Dapsone 100mg
Dosage Form: Tablet
New Zealand Sponsor: Link Pharmaceuticals Limited
Manufacturer: Jacobus Pharmaceutical Company Inc, New Jersey, United States of America
Product: Drixine No Drip Formula - Menthol Vapours Pump Mist Nasal Spray
Active Ingredient: Oxymetazoline hydrochloride 0.5mg/mL
Dosage Form: Nasal spray solution
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Contract Pharmaceuticals Limited, Ontario, Canada
Product: Drixine No Drip Formula - Moisturising Pump Mist Nasal Spray
Active Ingredient: Oxymetazoline hydrochloride 0.5mg/mL
Dosage Form: Nasal spray solution
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Contract Pharmaceuticals Limited, Ontario, Canada
Product: Elaprase
Active Ingredient: Idursulfase 2mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturers: CANGENE bioPharma, Maryland, United States of America
Baxter Pharmaceutical Solutions LLC, Indiana, United States of America
Product: Epiccord
Active Ingredient: Epirubicin hydrochloride 2mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Ahmedabad, India
Product: Escitalopram
Active Ingredient: Escitalopram oxalate 25.548mg equivalent to 20mg escitalopram
Dosage Form: Film coated tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Cipla Limited, Maharashtra, India
Product: Escitalopram
Active Ingredient: Escitalopram oxalate 12.774mg equivalent to 10mg escitalopram
Dosage Form: Film coated tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Cipla Limited, Maharashtra, India
Product: Escitalopram
Active Ingredient: Escitalopram oxalate 6.387mg equivalent to 5mg escitalopram
Dosage Form: Film coated tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Cipla Limited, Maharashtra, India
Product: Eyeprost
Active Ingredient: Latanoprost 0.05mg
Dosage Form: Eye drops, solution
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturers: Pharma Stulln GmbH, Stullin, Germany
Jadran Galenski Laboratorij d.d, Rijeka, Croatia
Product: Ibuprofen
Active Ingredient: Ibuprofen 2%
Dosage Form: Oral suspension
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Meditab Specialities Pvt Limited, Maharashtra, India
Product: Nicabate Mini Mint
Active Ingredient: Nicotine 1.5mg
Dosage Form: Lozenge
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Consumer Healthcare LP, South Carolina, United States of America
Product: Nicabate Mini Mint
Active Ingredient: Nicotine 4mg
Dosage Form: Lozenge
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Consumer Healthcare LP, South Carolina, United States of America
Product: Nicorette Freshdrops 2mg Lozenge
Active Ingredient: Nicotine tartrate 6.2mg
Dosage Form: Lozenge
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: McNeil AB, Helsingborg, Sweden
Product: Ondanaccord
Active Ingredient: Ondansetron hydrochloride dihydrate 2mg/mL equivalent to 2mg ondansetron
Dosage Form: Solution for injection
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Ahmedabad, India
Product: Predictor
Active Ingredients: Goat anti-(rabbit IgG) polyclonal antibody 2µg
Murine anti-beta-hCG monoclonal antibody-colloidal gold conjugate 2µg
Murine monoclonal antibody to alpha HCG 2µg
Normal Rabbit IgG-Colloidal Gold Conjugate 0.25µg
Dosage Form: Pregnancy test kit
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Tianjin New Bay Bioresearch Co. Limited, Tianjin, China
Product: Solox Relief
Active Ingredient: Lansoprazole 15mg
Dosage Form: Capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Liconsa SA, Guadalajara, Spain
Dated this 18th day of November 2010.
STEWART JESSAMINE, Acting Deputy Director-General, Population Health Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).