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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: Aqualax
Active Ingredient: Macrogol 3350 100%
Dosage Form: Powder for oral solution
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: Perrigo Holland Inc, Michigan, United States of America
Product: ClearLax
Active Ingredient: Macrogol 3350 100%
Dosage Form: Powder for oral solution
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: Perrigo Holland Inc, Michigan, United States of America
Product: Colgate Sensitive Pro-Relief Toothpaste
Active Ingredients: Arginine 8%w/w
Sodium monofluorophosphate 1.1%w/w
Dosage Form: Toothpaste
New Zealand Sponsor: Colgate-Palmolive Limited (NZ)
Manufacturer: Colgate-Palmolive Indústria e Comércio LTDA, São Paulo, Brazil
Product: Colgate Sensitive Pro-Relief Toothpaste - Whitening
Active Ingredients: Arginine 8%w/w
Sodium monofluorophosphate 1.1%w/w
Dosage Form: Toothpaste
New Zealand Sponsor: Colgate-Palmolive Limited (NZ)
Manufacturer: Colgate-Palmolive Indústria e Comércio LTDA, São Paulo, Brazil
Product: Docetaxel Actavis®20
Active Ingredient: Docetaxel 20mg
Dosage Form: Concentrate for injection
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: SC Sindan-Pharma SrL, Bucharest, Romania
Product: Docetaxel Actavis®80
Active Ingredient: Docetaxel 80mg
Dosage Form: Concentrate for injection
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: SC Sindan-Pharma SrL, Bucharest, Romania
Product: Docetaxel Actavis®140
Active Ingredient: Docetaxel 140mg
Dosage Form: Concentrate for injection
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: SC Sindan-Pharma SrL, Bucharest, Romania
Product: Hylo-Forte
Active Ingredient: Sodium hyaluronate 2mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Ursapharm Arzneimittel GmbH, Saabrucken, Germany
Product: Hylo-Tear
Active Ingredient: Sodium hyaluronate 1mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Ursapharm Arzneimittel GmbH, Saabrucken, Germany
Product: Kliovance Low
Active Ingredients: Estradiol hemihydrate 0.517mg
Norethisterone acetate 0.1mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, M†løv, Denmark
Product: Loratyne
Active Ingredient: Loratadine 10mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Micro Labs Limited, Tamil Nadu, India
Product: Oncotaxel 20
Active Ingredient: Docetaxel 20mg
Dosage Form: Concentrate for injection
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: SC Sindan-Pharma SrL, Bucharest, Romania
Product: Oncotaxel 80
Active Ingredient: Docetaxel 80mg
Dosage Form: Concentrate for injection
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: SC Sindan-Pharma SrL, Bucharest, Romania
Product: Oncotaxel 140
Active Ingredient: Docetaxel 140mg
Dosage Form: Concentrate for injection
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: SC Sindan-Pharma SrL, Bucharest, Romania
Product: Panadol Tablets with Optizorb Formulation (General Sale)
Active Ingredient: Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: GlaxoSmithKline Dungarvan Limited, Co. Waterford, Ireland
GlaxoSmithKline Australia Pty Limited, Ermington, Australia
Product: Panadol Tablets with Optizorb Formulation (Pharmacy Only)
Active Ingredient: Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: GlaxoSmithKline Dungarvan Limited, Co. Waterford, Ireland
GlaxoSmithKline Australia Pty Limited, Ermington, Australia
Product: RevitaLens OcuTec Multi-Purpose Disinfecting Solution
Active Ingredients: Alexidine dihydrochloride 0.00016%w/w
Polidronium chloride 0.0003%w/w
Dosage Form: Contact lens solution
New Zealand Sponsor: AMO Australia Pty Limited
Manufacturers: AMO (Hangzhou) Co. Limited, Zhejiang, China
AMO Manufacturing Spain S.L., Madrid, Spain
Product: Risedronate Sodium
Active Ingredient: Risedronate sodium 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Risedronate Sodium
Active Ingredient: Risedronate sodium 35mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Tykerb
Active Ingredient: Lapatinib ditosilate 405mg equivalent to Lapatinib free base 250mg
Dosage Form: Tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Glaxo Operations UK Limited (t/a Glaxo Wellcome Operations), Hertfordshire, United Kingdom
Product: Your Pharmacy Clear Laxative
Active Ingredient: Macrogol 3350 100%
Dosage Form: Powder for oral solution
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: Perrigo Holland Inc, Michigan, United States of America
Product: Your Pharmacy Sinus Pain Relief PE
Active Ingredients: Paracetamol 500mg
Phenylephrine hydrochloride 6.1mg equivalent to phenylephrine 5mg
Dosage Form: Capsule
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: Wrafton Laboratories Limited, Devon, United Kingdom
Dated this 9th day of January 2012.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).