Notice Type
Departmental
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 Name and Strength Form Name and Address of Manufacturer Proprietary Name(if any) Acetic acid 3% v/v, 5% v/v in 100 mL Solution, irrigation McGaw Biomed Limited, Point Chevalier, Auckland Acetic Acid Imiquimod 5% w/w in 250 mg Cream, skin 3M Health Care (UK) Limited, Loughborough, Leicestershire, England Aldara Amphotericin B 50 mg Injection, powder for, vial NeXstar Pharmaceuticals Inc., San Dimas, California, United States of America AmBisome Sodium fluoride 0.0442% w/v equivalent to 0.2 mg/mL fluoride in 500 mL Solution, oral Pharmaction Manufacturing Pty Limited, Laverton North, Victoria, Australia Colgate Fluorocare Acidulated Phosphate Fluoride, Daily Fluoride Mouth Rinse (Orange flavour) Sodium fluoride 0.0442% w/v equivalent to 0.2 mg/mL fluoride in 500 mL Solution, oral Pharmaction Manufacutring Pty Limited, Laverton North, Victoria, Australia Colgate Fluorocare Acidulated Phosphate Fluoride, Daily Fluoride Mouth Rinse (Lime flavour) Hydrofluoric acid 0.349% w/w (of a 48% solution) sodium fluoride 2.283% w/w equivalent to 1.2% w/v fluoride in 473 mL Gel, oral, topical Colgate Oral Pharmaceuticals, Dallas, Texas, United States of America Colgate Fluorocare Acidulated Phosphate Fluoride, Professional Fluoride Topical Gel (Fresh Mint flavour) Hydrofluoric acid 0.722% w/v (of a 48% solution) sodium fluoride 2% w/v equivalent to 1.23% w/v fluoride in 250 mL Solution, oral, topical Pharmaction Manufacturing Pty Limited, Laverton North, Victoria, Australia Colgate Fluorocare Acidulated Phosphate Fluoride, Professional Fluoride Solution Sodium fluoride 2.72% w/v equivalent to 1.23% w/v fluoride in 30 mL, 250 mL Gel, oral, topical Pharmaction Manufacturing Pty Limited, Laverton North, Victoria, Australia Colgate Neutrafluor Neutral Sodium Fluoride, Fluoride Topical Gel Chlorhexidine gluconate 0.2% w/v in 30 mL, 250 mL Gel, oral, topical Pharmaction Manufacturing Pty Limited, Laverton North, Victoria, Australia Colgate Periogard Chlorohex Antiseptic Mouth Gel Chlorhexidine gluconate 2% w/v in 30 mL Gel, oral, topical Pharmaction Manufacturing Pty Limited, Laverton North, Victoria, Australia Colgate Periogard Chlorohex Forte Antiseptic Mouth Gel Valsartan 80 mg, 160 mg Capsules Novartis Pharma Stein AG/SA Inc., Stein, Switzerland Diovan Erythromycin 2% w/w, 4% w/w in 30 g Gel, topical Laboratoires Galderma, Alby Sur Cheran, France Eryacne Alanine 16.0 g/L, arginine 11.3 g/L, aspartic acid 3.4 g/L, glutamic acid 5.6 g/L, glycyl-glutamine HO 30.27 g/L, glycyl-tyrosine 2HO 3.45 g/L, histidine 6.8 g/L, isoleucine 5.6 g/L, leucine 7.9 g/L, lysine-acetate 12.7 g/L, methionine 5.6 g/L, phenyalanine 5.85 g/L, proline 6.8 g/L, serine 4.5 g/L, threonine 5.6 g/L, tyrptophan 1.9 g/L, valine 7.3 g/L in 250 mL, 500 mL, 1 L Solution, infusion Pharmacia GmbH., Plattling, Germany Glamin Paracetamol 500 mg Tablet Herron Pharmaceuticals Pty Limited, Tennyson, Queensland, Australia Herron Paracetamol Cadexomer iodine 60% w/w in 5 g, 10 g, 17 g Dressing, medicated Perstorp Pharma, Ideon, Sweden HydroHeal Medicated Cadexomer iodine 50% w/w in 10 g, 20 g, 40 g Ointment, skin Perstorp Pharma, Ideon, Sweden HydroHeal Medicated Dextromethorphan hydrobromide 1 mg/mL in 100 mL, 200 mL Solution, oral PSM Holdings Limited, Wiri, Auckland Medco Tickly Cough Mixture Levonorgestrel 52 mg equivalent to 20 g/24 hours Intrauterine contraceptive device Leiras Oy, Turku, Finland Mirena Mometasone furoate monohydrate 50 g/dose Spray, nasal, metered dose Schering-Plough Laboratories NV., Heist-op-den-Berg, Belgium and Schering-Plough Products Inc., Manati, Puerto Rico Nasonex Orphenadrine citrate 35 mg, paracetamol 450 mg Tablet 3M Pharmaceuticals (Australia) Pty Limited, Thornleigh, New South Wales, Australia Norgesic Codeine phosphate 8 mg, doxylamine succinate 5 mg, paracetamol 500 mg Capsule SmithKline Beecham Pharmaceuticals, Dandenong, Victoria, Australia and SmithKline Beecham (Australia) Pty Limited, Ermington, New South Wales, Australia Panadeine Plus Potassium chloride 2 mmol/mL in 25 mL Solution, oral McGaw Biomed Limited, Point Chevalier, Auckland Potassium Chloride Ropinirole hydrochloride 0.285 mg, 0.57 mg, 1.14 mg, 2.28 mg, 5.7 mg equivalent to 0.25 mg, 0.5 mg, 1 mg, 2 mg, 5 mg ropinirole Tablets, film coated SmithKline Beecham Pharmaceuticals, Magpie Wood, Manor Royal, Crawley, Sussex, England Requip Mometasone furoate monohydrate 50 g/dose Spray, nasal, metered dose Schering-Plough Laboratories NV., Heist-op-den-Berg, Belgium and Schering-Plough Products Inc., Manati, Puerto Rico Rhinax Montelukast sodium 5.2 mg, equivalent to 5 mg montelukast Tablet, chewable Merck Sharp & Dohme Limited, Cramlington, Northumberland, England and Merck Sharp & Dohme (Aust) Pty Limited, South Granville, New South Wales, Australia Singulair Montelukast sodium 10.4 mg, equivalent to 10 mg montelukast Tablet Merck Sharp & Dohme Limited, Cramlington, Northumberland, England and Merck Sharp & Dohme (Aust) Pty Limited, South Granville, New South Wales, Australia Singulair Paclitaxel 6 mg/mL in 5 mL, 16.7 mL, 25 mL Infusion, concentrate for, vial Bristol-Caribbean Inc., Mayaguez, Puerto Rico Taxol Laurdimonium hydrolised animal collagen 0.085 mg/mL, polyxetonium chloride 0.06 mg/mL in 60 mL, 120 mL Solution, contact lens Allergan Pharmaceuticals (Ireland) Limited, Westport, County Mayo, Eire Total Care Disinfecting, Storing and Wetting Solution Mometasone furoate monohydrate 50 g/dose Spray, nasal, metered dose Schering-Plough Laboratories NV., Heist-op-den-Berg, Belgium and Schering-Plough Products Inc., Manati, Puerto Rico Uniclar Orlistat 120 mg Capsule F Hoffman-La Roche Limited, Basle, Switzerland Xenical Dated this 24th day of March 1998. G. R. BOYD, Chief Advisor, Regulation and Safety, pursuant to delegation given by the Minister of Health on the 20th day of February 1997.
Publication Date
2 Apr 1998

Notice Number

1998-go2091

Page Number

1101