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 inNew 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) Amoxicillin trihydrate 25 mg, clavulanic potassium 6.25 mg per mL in 100 mL Oral suspension Lek Pharmaceutical and Chemical Company, Ljubljana, Slovenia Amoxyclav Amoxicillin trihydrate 50 mg, clavulanic potassium 12.5 mg per mL in 100 mL Oral suspension Lek Pharmaceutical and Chemical Company, Ljubljana, Slovenia Amoxyclav Forte Sulphamethoxazole 400 mg, trimethoprim 80 mg Tablet Apotex Inc., Weston, Ontario, Canada Apo-Sulfatrim Sulphamethoxazole 800 mg, trimethoprim 160 mg Tablet Apotex Inc., Weston, Ontario, Canada Apo-Sulfatrim DS BCG vaccine (Danish strain 1331) 0.75 mg/1 mL and diluent Powder for injection, vial Statens Serum Institut, Copehagen S, Denmark BCG-Vaccine SSI Bovine serum albumin 0.6 mcg, goat anti-mouse polyclonal antibody 4.9 mcg, murine monoclonal antibody to Alpha hCG 0.9 mcg, murine monoclonal antibody to Beta hCG 1.8 mcg Pregnancy test kit Syntron Bioresearch Inc., Carlsbad, California, United States of America Crystal Clear Cefuroxime sodium 1577.7 mg (equivalent to 1500 mg cefuroxime in 100 mL) Powder for infusion, bottle Eli Lilly Italia SpA., Sesto Fiorentino, Florence, Italy Keroxime Cefuroxime sodium 262.9 mg (equivalent to 250 mg cefuroxime in 10 mL), 788.8 mg (equivalent to cefuroxime 750 mg in 10 mL), 1577.7 mg (equivalent to 1500 mg cefuroxime in 20 mL) Powder for injection, vial Eli Lilly Italia SpA., Sesto Fiorentino, Florence, Italy Keroxime Chlorhexidine gluconate 20% w/v Solution, topical Johnson & Johnson Medical Pty Limited, North Ryde, New South Wales, Australia Microshield 20 20% Chlorhexidine Concentrate Chlorhexidine gluconate 5% w/v Solution, topical Johnson & Johnson Medical Pty Limited, North Ryde, New South Wales, Australia Microshield 5 5% Chlorhexidine Concentrate Varicella virus, live attenuated not less than 1000 PFU per 0.5 mL dose and diluent Injection, vial; diluent, ampoule and syringe SmithKline Beecham Biologicals, Rixensart, Belguim Valrilrix Dated this 9th day of September 1996. HUGH BABER, Assistant General Manager, Health Regulation and Protection, pursuant to delegation given by the Minister of Health on the 18th day of January 1996.
Publication Date
12 Sep 1996

Notice Number

1996-go5875

Page Number

2930