Notice Type
Departmental
Consent to the Distribution of a New Medicine Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the Schedule hereto: Schedule Product: Ciproxin HC Otic Drops. Active Ingredient(s): Ciprofloxacin hydrochloride 2.33 mg equivalent to 0.2% ciprofloxacin. Hydrocortisone 10 mg equivalent to 1% hydrocortisone. Dosage Form: Ear drops. NZ Sponsor: Bayer New Zealand Limited Health Care Division. Manufacturer(s): Bayer Corporation, Myerstown, Pennsylvania, United States of America. Product: Infanrix-Hib vaccine (Combination Product). Active Ingredient(s): Tetanus toxoid 40IU. Diphtheria toxoid (adsorbed) 30 IU. Detoxified pertussis toxin 25 g. Pertussis filamentous haemagglutinin 25 g. Pertactin 8 g. Dosage Form: Suspension for injection. Manufacturer(s): SmithKline Beecham Biologicals SA, Rixensart, Belgium. Active Ingredient(s): Haemophilus influenzae vaccine (tetanus toxoid conjugate) 10 g. Dosage Form: Powder for injection. Manufacturer(s): SmithKline Beecham Biologicals SA, Rixensart, Belgium. NZ Sponsor: SmithKline Beecham (NZ) Limited. Product: Lactulose Syrup. Active Ingredient(s): Lactulose 667 mg/mL. Dosage Form: Oral solution. NZ Sponsor: Technilab Inc. Manufacturer(s): Technilab Inc, Lapointe, Mirabel, Quebec, Canada. Product: Naprosyn. Active Ingredient(s): Naproxen 25 mg/mL. Dosage Form: Oral suspension. NZ Sponsor: Roche Products (New Zealand) Limited. Manufacturer(s): Roche Products Limited, Stepfield, Witham, Essex, United Kingdom. Product: Priorix. Active Ingredient(s): Rubella virus (Wistar RA27/3 strain) 1,000 CCID50. Measles vaccine (Schwarz strain) 1,000 CCID50. Mumps virus, live attenuated (RIT 4385) 5,012 CCID50. Dosage Form: Powder for injection. NZ Sponsor: SmithKline Beecham (NZ) Limited. Manufacturer(s): Sachsisches Serumwerk Dresden, Branch of SKB Pharma GmbH, Dresden, Germany. SmithKline Beecham Biologicals SA, Rixensart, Belgium. SmithKline Beecham Biologicals SA, Genval, Belgium. 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-go6108

Page Number

2425