2 MARCH NEW ZEALAND GAZETTE 423

Dosage Form: Topical gel
NZ Sponsor: Bayer New Zealand Limited Health Care Division
Manufacturer(s): Trononwerke 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).
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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: Hycamtin
Active Ingredient(s): Topotecan hydrochloride 4.49mg/dose equivalent to 4mg topotecan
Dosage Form: Powder for infusion
NZ Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer(s): SmithKline Beecham Pharmaceuticals, Anti-infective manufacturing operations, Conshohocken, Pennsylvania, United States of America

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).
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Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23 of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the schedule hereto:

Schedule

Product: Viramune
Active Ingredient(s): Nevirapine hemihydrate 10.35mg/mL
Dosage Form: Oral suspension
NZ Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer(s): Roxane Laboratories Inc, Columbus, Ohio, United States of America