Notice Type
Departmental
Consent to the Distribution of Changed Medicines Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicines which were referred to the Minister of Health under the provisions of section 24 (5) of the act and are set out in the Schedule hereto: Schedule Product: Ciproxin. Active Ingredient(s): Ciprofloxacin lactate 2 mg/mL. Dosage Form: Solution for injection. NZ Sponsor: Bayer New Zealand Limited Health Care Division. Manufacturer(s): Bayer AG, Leverkusen, Germany. Product: Ciproxin. Active Ingredient(s): Ciprofloxacin hydrochloride 116.44 mg/mL equivalent to 100 mg/mL ciprofloxacin. Dosage Form: Oral suspension. NZ Sponsor: Bayer New Zealand Limited Health Care Division. Manufacturer(s): Bayer SpA, Garbagnate, Milanese, Italy. Product: Ciproxin. Active Ingredient(s): Ciprofloxacin hydrochloride 58.22 mg/mL equivalent to 50 mg/mL ciprofloxacin. Dosage Form: Oral suspension. NZ Sponsor: Bayer New Zealand Limited Health Care Division. Manufacturer(s): Bayer SpA, Garbagnate, Milanese, Italy. Product: Ciproxin. Active Ingredient(s): Ciprofloxacin hydrochloride 100 mg. Dosage Form: Tablet. NZ Sponsor: Bayer New Zealand Limited Health Care Division. Manufacturer(s): Bayer AG, Leverkusen, Germany. Product: Ciproxin. Active Ingredient(s): Ciprofloxacin hydrochloride 250 mg. Dosage Form: Tablet. NZ Sponsor: Bayer New Zealand Limited Health Care Division. Manufacturer(s): Bayer AG, Leverkusen, Germany. Product: Ciproxin. Active Ingredient(s): Ciprofloxacin hydrochloride 500 mg. Dosage Form: Tablet. NZ Sponsor: Bayer New Zealand Limited Health Care Division. Manufacturer(s): Bayer AG, Leverkusen, Germany. Product: Ciproxin. Active Ingredient(s): Ciprofloxacin hydrochloride 750 mg. Dosage Form: Tablet. NZ Sponsor: Bayer New Zealand Limited Health Care Division. Manufacturer(s): Bayer AG, Leverkusen, Germany. Product: Esmeron. Active Ingredient(s): Rocuronium bromide 10 mg/mL. Dosage Form: Solution for injection. NZ Sponsor: Pharmaco (NZ) Limited. Manufacturer(s): Organon International BV, Oss, The Netherlands. Organon Laboratories Limited, Newhouse, Motherwell, Lanarkshire, Scotland. Organon SA, Usine Saint-Charles, Eragny-sur-Epte, Serifontaine, France. Product: Kliovance. Active Ingredient(s): Norethisterone acetate 0.5 mg. Oestradiol hemihydrate 1.03 mg equivalent to 1 mg oestradiol. Dosage Form: Film coated tablet. NZ Sponsor: Novo Nordisk Pharmaceuticals Limited. Manufacturer(s): Novo Nordisk A/S, Maaloev, Denmark. Product: Valtrex. Active Ingredient(s): Valaciclovir hydrochloride 1,112 mg equivalent to 1,000 mg valaciclovir. Dosage Form: Film coated tablet. NZ Sponsor: Glaxo Wellcome New Zealand Limited. Manufacturer(s): Glaxo Wellcome Operations, Temple Hill, Dartford, Kent, United Kingdom. Product: Valtrex. Active Ingredient(s): Valaciclovir hydrochloride 278 mg equivalent to 250 mg valacilovir. Dosage Form: Film coated tablet. NZ Sponsor: Glaxo Wellcome New Zealand Limited. Manufacturer(s): Glaxo Wellcome Operations, Ware, Hertfordshire, United Kingdom. Glaxo Wellcome Operations, Temple Hill, Dartford, Kent, United Kingdom. Product: Valtrex. Active Ingredient(s): Valaciclovir hydrochloride 556 mg equivalent to 500 mg valaciclovir. Dosage Form: Film coated tablet. NZ Sponsor: Glaxo Wellcome New Zealand Limited. Manufacturer(s): Glaxo Wellcome Operations, Ware, Hertfordshire, United Kingdom. Glaxo Wellcome Operations, Temple Hill, Dartford, Kent, United Kingdom. Product: Zoladex implant. Active Ingredient(s): Goserelin acetate 11.34 mg equivalent to 10.8 mg goserelin. Dosage Form: Subcutaneous implant. NZ Sponsor: AstraZeneca Limited. Manufacturer(s): Zeneca Pharmaceuticals, Macclesfield, Cheshire, England. Dated this 18th day of August 1999. G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).
Publication Date
26 Aug 1999

Notice Number

1999-go6112

Page Number

2426