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: Glivec
Active Ingredient: Imatinib mesilate 119.5mg equivalent to 100mg imatinib base
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Glivec
Active Ingredient: Imatinib mesilate 59.75mg equivalent to 50mg imatinib base
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Glivec
Active Ingredient: Imatinib mesilate 119.5mg equivalent to imatinib base 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Glivec
Active Ingredient: Imatinib mesilate 478mg equivalent to imatinib base 400mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Lexapro
Active Ingredient: Escitalopram oxalate 12.77mg equivalent to Escitalopram 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturers: H Lundbeck A/S, Ottiliavej 9, Valby, Denmark
Patheon France S.A., Bourgoin-Jallieu, France
Product: Lexapro
Active Ingredient: Escitalopram oxalate 19.16mg equivalent to Escitalopram 15mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: H Lundbeck A/S, Valby, Denmark
Product: Lexapro
Active Ingredient: Escitalopram oxalate 25.54mg equivalent to Escitalopram 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: H Lundbeck A/S, Valby, Denmark
Product: Lexapro
Active Ingredient: Escitalopram oxalate 6.39mg equivalent to Escitalopram 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: H Lundbeck A/S, Valby, Denmark
Dated this 6th day of October 2006.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).