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: Maxipime
Active Ingredient(s): Cefepime hydrochloride (monohydrate) 1.202g equivalent to 1.0g cefepime
Dosage Form: Powder for injection
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer(s): Bristol-Myers Squibb Barceloneta Inc, Barceloneta, Puerto Rico
Bristol-Myers Squibb SpA, Sermoneta, Latina, Italy
Product: Maxipime
Active Ingredient(s): Cefepime hydrochloride (monohydrate) 2.404g equivalent to 2.0g cefepime
Dosage Form: Powder for injection
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer(s): Bristol-Myers Squibb Barceloneta Inc, Barceloneta, Puerto Rico
Bristol-Myers Squibb SpA, Sermoneta, Latina, Italy
Product: Maxipime
Active Ingredient(s): Cefepime hydrochloride (monohydrate) 601mg equivalent to 500mg cefepime
Dosage Form: Powder for injection
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer(s): Bristol-Myers Squibb Barceloneta Inc, Barceloneta, Puerto Rico
Bristol-Myers Squibb SpA, Sermoneta, Latina, Italy
Product: Temodal
Active Ingredient(s): Temozolomide 100mg
Dosage Form: Capsule
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer(s): Integrated Therapeutics Group Inc Subsidiary Schering-Plough Corporation, Iowa City, Iowa, United States of America
Note: This product has provisional consent.
Product: Temodal
Active Ingredient(s): Temozolomide 20mg
Dosage Form: Capsule
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer(s): Integrated Therapeutics Group Inc Subsidiary Schering-Plough Corporation, Iowa City, Iowa, United States of America
Note: This product has provisional consent.
Product: Temodal
Active Ingredient(s): Temozolomide 250mg
Dosage Form: Capsule
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer(s): Integrated Therapeutics Group Inc Subsidiary Schering-Plough Corporation, Iowa City, Iowa, United States of America
Note: This product has provisional consent.
Product: Temodal
Active Ingredient(s): Temozolomide 5mg
Dosage Form: Capsule
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer(s): Integrated Therapeutics Group Inc Subsidiary Schering-Plough Corporation, Iowa City, Iowa, United States of America
Note: This product has provisional consent.
Product: Temoxol
Active Ingredient(s): Temozolomide 100mg
Dosage Form: Capsule
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer(s): Integrated Therapeutics Group Inc Subsidiary Schering-Plough Corporation, Iowa City, Iowa, United States of America
Note: This product has provisional consent.
Product: Temoxol
Active Ingredient(s): Temozolomide 20mg
Dosage Form: Capsule
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer(s): Integrated Therapeutics Group Inc Subsidiary Schering-Plough Corporation, Iowa City, Iowa, United States of America
Note: This product has provisional consent.
Product: Temoxol
Active Ingredient(s): Temozolomide 250mg
Dosage Form: Capsule
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer(s): Integrated Therapeutics Group Inc Subsidiary Schering-Plough Corporation, Iowa City, Iowa, United States of America
Note: This product has provisional consent.
Product: Temoxol
Active Ingredient(s): Temozolomide 5mg
Dosage Form: Capsule
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer(s): Integrated Therapeutics Group Inc Subsidiary Schering-Plough Corporation, Iowa City, Iowa, United States of America
Note: This product has provisional consent.
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.