Medicines Consent Notices




15 JUNE NEW ZEALAND GAZETTE 1439

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:
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
Haemophilus influenzae vaccine (tetanus toxoid conjugate) 20µg/mL
Dosage Form:
Suspension 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):
Dipharm Manufacturing and Packaging Co, Longdale, Johannesburg, South Africa

Product:
Ospamox
Active Ingredient(s):
Amoxycillin (trihydrate) 117.1mg/mL equivalent 100mg/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) 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



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2000, No 65


Gazette.govt.nz PDF NZ Gazette 2000, No 65





✨ LLM interpretation of page content

🏥 Consent to the Distribution of a New Medicine (continued from previous page)

🏥 Health & Social Welfare
15 June 2000
Medicine, Distribution, Azmacort, Hiberix, Infanrix-IPV+Hib, Linotar Gel, Ospamox, Paracetamol Junior Suspension
  • Minister of Health