Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new 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: Pegatron Combination Therapy (Combination Product)
PEG-Intron dose:
Active Ingredient: Peginterferon alfa-2b 50mcg
Dosage Form: Powder for injection with diluent
Rebetol dose:
Active Ingredient: Ribavirin 200mg
Dosage Form: Capsule
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Schering-Plough Products Inc, Las Piedras, Puerto Rico
MSD International GmbH (Singapore Branch), Singapore
Product: Pegatron Combination Therapy (Combination Product)
PEG-Intron dose:
Active Ingredient: Peginterferon alfa-2b 80mcg
Dosage Form: Powder for injection with diluent
Rebetol dose:
Active Ingredient: Ribavirin 200mg
Dosage Form: Capsule
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Schering-Plough Products Inc, Las Piedras, Puerto Rico
MSD International GmbH (Singapore Branch), Singapore
Product: Pegatron Combination Therapy (Combination Product)
PEG-Intron dose:
Active Ingredient: Peginterferon alfa-2b 100mcg
Dosage Form: Powder for injection with diluent
Rebetol dose:
Active Ingredient: Ribavirin 200mg
Dosage Form: Capsule
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Schering-Plough Products Inc, Las Piedras, Puerto Rico
MSD International GmbH (Singapore Branch), Singapore
Product: Pegatron Combination Therapy (Combination Product)
PEG-Intron dose:
Active Ingredient: Peginterferon alfa-2b 120mcg
Dosage Form: Powder for injection with diluent
Rebetol dose:
Active Ingredient: Ribavirin 200mg
Dosage Form: Capsule
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Schering-Plough Products Inc, Las Piedras, Puerto Rico
MSD International GmbH (Singapore Branch), Singapore
Product: Pegatron Combination Therapy (Combination Product)
PEG-Intron dose:
Active Ingredient: Peginterferon alfa-2b 150mcg
Dosage Form: Powder for injection with diluent
Rebetol dose:
Active Ingredient: Ribavirin 200mg
Dosage Form: Capsule
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Schering-Plough Products Inc, Las Piedras, Puerto Rico
MSD International GmbH (Singapore Branch), Singapore
Product: Tarceva
Active Ingredient: Erlotinib hydrochloride 27.32mg equivalent to erlotinib 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: F Hoffmann-La Roche Limited, Basel, Switzerland
Roche SpA, Milan, Italy
Kremers Urban Pharmaceuticals Inc, Indiana, United States of America
Product: Tarceva
Active Ingredient: Erlotinib hydrochloride 109.29mg equivalent to erlotinib 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: F Hoffmann-La Roche Limited, Basel, Switzerland
Roche SpA, Milan, Italy
Kremers Urban Pharmaceuticals Inc, Indiana, United States of America
Product: Tarceva
Active Ingredient: Erlotinib hydrochloride 163.93mg equivalent to erlotinib 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: F Hoffmann-La Roche Limited, Basel, Switzerland
Roche SpA, Milan, Italy
Kremers Urban Pharmaceuticals Inc, Indiana, United States of America
Dated this 7th day of February 2013.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).