Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

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: Clopidogrel Sandoz
Active Ingredient: Clopidogrel bisulfate 97.875mg equivalent to 75mg clopidogrel
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Sandoz Private Limited, Navi Mumbai, India
Product: DP-Acitretin
Active Ingredient: Acitretin 25mg
Dosage Form: Capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Micro-Sphere S.A, Madonna del Piano, Switzerland
Product: DP-Acitretin
Active Ingredient: Acitretin 10mg
Dosage Form: Capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Micro-Sphere S.A, Madonna del Piano, Switzerland
Product: DP-Omeprazole
Active Ingredient: Omeprazole 10mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Laboratorios Liconsa S.A., Azuqueca de Henares (Guadalajara), Spain
Product: DP-Omeprazole
Active Ingredient: Omeprazole 20mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Laboratorios Liconsa S.A., Azuqueca de Henares (Guadalajara), Spain
Product: DP-Omeprazole
Active Ingredient: Omeprazole 40mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Laboratorios Liconsa S.A., Azuqueca de Henares (Guadalajara), Spain
Product: Duolin HFA
Active Ingredients: Ipratropium bromide monohydrate 0.021mg equivalent to ipratropium bromide anhydrous 0.020mg
Salbutamol sulfate 0.12mg equivalent to salbutamol 0.100mg
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India
Product: Duro-Tuss Chesty Cough Liquid Forte
Active Ingredients: Bromhexine hydrochloride 0.8mg/mL
Guaifenesin 20mg/mL
Dosage Form: Solution
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturer: iNova Pharmaceuticals (Australia) Pty Limited, Thornleigh, Australia
Product: Hayzep
Active Ingredient: Desloratadine 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: McDermott Laboratories t/a Gerard Laboratories, Dublin, Ireland
Product: Mestane
Active Ingredient: Exemestane 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Pharmaceuticals (Fiji) Limited, Nadi, Fiji
Product: Neupro
Active Ingredient: Rotigotine 4.5mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Pharmabroker Sales Limited
Manufacturer: LTS Lohmann Therapie-Systeme AG, Andernach, Germany
Product: Neupro
Active Ingredient: Rotigotine 9mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Pharmabroker Sales Limited
Manufacturer: LTS Lohmann Therapie-Systeme AG, Andernach, Germany
Product: Neupro
Active Ingredient: Rotigotine 13.5mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Pharmabroker Sales Limited
Manufacturer: LTS Lohmann Therapie-Systeme AG, Andernach, Germany
Product: Neupro
Active Ingredient: Rotigotine 18mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Pharmabroker Sales Limited
Manufacturer: LTS Lohmann Therapie-Systeme AG, Andernach, Germany
Product: Sauflon Multi Preservative Free One Step Multifunction Solution
Active Ingredient: Hydrogen peroxide 3.5%w/v
Dosage Form: Contact lens solution
New Zealand Sponsor: Pharmaceutical Marketing New Zealand Limited
Manufacturer: Sauflon Pharmaceuticals Limited, Kent, United Kingdom
Dated this 11th 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).