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: Alpha-Amoxi
Active Ingredient(s): Amoxycillin (trihydrate) 297.95mg equivalent to 250mg amoxycillin
Dosage Form: Capsule
NZ Sponsor: Apotex (NZ) Limited
Manufacturer(s): Ranbaxy Laboratories Limited, Dewas, Madhya Pradesh, India
Product: Alpha-Amoxi
Active Ingredient(s): Amoxycillin (trihydrate) 595.9mg equivalent to 500mg amoxycillin
Dosage Form: Capsule
NZ Sponsor: Apotex (NZ) Limited
Manufacturer(s): Ranbaxy Laboratories Limited, Dewas, Madhya Pradesh, India
Product: Orochol Berna
Active Ingredient(s): Recombinant live V. cholerae CVD 103-HgR 600MCFU
Dosage Form: Powder
NZ Sponsor: Pharmabroker Sales Limited
Manufacturer(s): Swiss Serum & Vaccine Institute, Thorishaus, Switzerland
Product: Rheumon
Active Ingredient(s): Etofenamate 50mg/g
Dosage Form: Topical gel
NZ Sponsor: Bayer New Zealand Limited Health Care Division
Manufacturer(s): Troponwerke GmbH & Co KG, Cologne, Germany
Product: Tramal SR 100
Active Ingredient(s): Tramadol hydrochloride 100mg
Dosage Form: Modified release tablet
NZ Sponsor: CSL (New Zealand ) Limited
Manufacturer(s): Grunenthal GmbH, Stolberg, Germany
Product: Tramal SR 150
Active Ingredient(s): Tramadol hydrochloride 150mg
Dosage Form: Modified release tablet
NZ Sponsor: CSL (New Zealand ) Limited
Manufacturer(s): Grunenthal GmbH, Stolberg, Germany
Product: Tramal SR 200
Active Ingredient(s): Tramadol hydrochloride 200mg
Dosage Form: Modified release tablet
NZ Sponsor: CSL (New Zealand ) Limited
Manufacturer(s): Grunenthal GmbH, Stolberg, Germany
Product: Tritanrix-HB+Hib (Combination Product)
Active Ingredient(s): Diphtheria toxoid (adsorbed) 60IU/mL
Tetanus toxoid 120IU/mL
Bordetella Pertussis (inactivated) 4IU/mL
Hepatitis B vaccine (rDNA) 20µg/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
NZ Sponsor: SmithKline Beecham (NZ) Limited
Dated this 24th day of February 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).