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: Azmacort 225
Active Ingredient(s): Triamcinolone acetonide 225µg/dose
Dosage Form: Suspension for inhalation
New Zealand Sponsor: Aventis Pharma Limited
Manufacturer(s): Rhone-Poulenc Rorer Puerto Rico Inc, Manati, Puerto Rico
Product: Azmacort 75
Active Ingredient(s): Triamcinolone acetonide 75µg/dose
Dosage Form: Solution for inhalation
New Zealand Sponsor: Aventis Pharma Limited
Manufacturer(s): Rhone-Poulenc Rorer Puerto Rico Inc, Manati, Puerto Rico
Product: Hiberix
Active Ingredient(s): Haemophilus influenzae vaccine (tetanus toxoid conjugate) 10µg/dose
Dosage Form: Powder for injection
New Zealand Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer(s): SmithKline Beecham Biologicals SA, Rixensart, Belgium
Product: Infanrix-IPV-Hib (Combination Product)
Active Ingredient(s): Polio virus type 1 80DAgU/mL
Detoxified pertussis toxin 50µg/mL
Pertussis 69kDa outer membrane protein 16µg/mL
Diphtheria toxoid (adsorbed) 60IU/mL
Polio virus type 2 16DAgU/mL
Polio virus type 3 64DAgU/mL
Adsorbed tetanus vaccine 80IU/mL
Pertussis filamentous haemagglutinin 50µg/mL
Dosage Form: Suspension for injection
Manufacturer(s): SmithKline Beecham Biologicals SA, Rixensart, Belgium
Active Ingredient(s): Haemophilus influenzae vaccine (tetanus toxoid conjugate) 20µg/mL
Dosage Form: Powder for injection
Manufacturer(s): SmithKline Beecham Biologicals SA, Rixensart, Belgium
New Zealand Sponsor: SmithKline Beecham (NZ) Limited
Product: Linotar Gel 3
Active Ingredient(s): Coal tar, prepared 3%w/w
Dosage Form: Topical emulsion
New Zealand Sponsor: Linotar New Zealand Pty Limited
Manufacturer(s): Divpharm Manufacturing and Packaging Co, Longdale, Johannesburg, South Africa
Product: Ospamox
Active Ingredient(s): Amoxycillin (trihydrate) 117.1mg/mL equivalent 100mg/mL amoxicillin
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Biochemie GmbH, Kundl, Austria
Product: Ospamox
Active Ingredient(s): Amoxycillin (trihydrate) 30.14mg/mL equivalent 25mg/mL amoxycillin
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Biochemie GmbH, Kundl, Austria
Product: Ospamox
Active Ingredient(s): Amoxycillin (trihydrate) 58.54mg/mL equivalent to 50mg/mL amoxycillin,
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Biochemie GmbH, Kundl, Austria
Product: Paracetamol Junior Suspension
Active Ingredient(s): Paracetamol 24mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Unichem Limited
Manufacturer(s): PSM Healthcare Ltd, Wiri, Auckland
Product: Propofol
Active Ingredient(s): Propofol 10mg/mL
Dosage Form: Emulsion for injection
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer(s): Abbott Laboratories, Chemical & Agricultural Products Division, North Chicago, Illinois, United States of America
Dated this 7th day of June 2000.
G. R. BOYD, Chief Advisor, Safety and Regulation, pursuant to delegation given by the Minister of Health on the 20th day of February 1997.