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 medicines set out in the Schedule hereto:
Schedule
Product: BayHep B
Active Ingredient: Hepatitis B immunoglobulin, human 217IU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Bayer New Zealand Limited Pharmaceutical Division
Manufacturer: Bayer Corporation, Clayton, North Carolina, United States of America
Note: This consent is valid for two years from 13 December 2003.
Product: Rapamune
Active Ingredient: Sirolimus 1mg
Dosage Form: Tablet
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer: Wyeth Pharmaceuticals Inc, Rouses Point, New York, United States of America
Note: This consent is valid for two years from 22 November 2003.
Product: Zerit
Active Ingredient: Stavudine 15mg
Dosage Form: Capsule
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturer: Bristol-Myers Squibb Company, Evansville, Indiana, United States of America
Note: This consent is valid for two years from 22 November 2003.
Product: Zerit
Active Ingredient: Stavudine 20mg
Dosage Form: Capsule
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturer: Bristol-Myers Squibb Company, Evansville, Indiana, United States of America
Note: This consent is valid for two years from 22 November 2003.
Product: Zerit
Active Ingredient: Stavudine 30mg
Dosage Form: Capsule
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturer: Bristol-Myers Squibb Company, Evansville, Indiana, United States of America
Note: This consent is valid for two years from 22 November 2003.
Product: Zerit
Active Ingredient: Stavudine 40mg
Dosage Form: Capsule
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturer: Bristol-Myers Squibb Company, Evansville, Indiana, United States of America
Note: This consent is valid for two years from 22 November 2003.
Product: Zerit
Active Ingredient: Stavudine 1mg/mL
Dosage Form: Powder for oral solution
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturer: Bristol-Myers Squibb Company, Evansville, Indiana, United States of America
Note: This consent is valid for two years from 22 November 2003.
Dated this 27th day of November 2003.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on the
6th day of July 2001).