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: Quetapel
Active Ingredient: Quetiapine fumarate 28.78mg equivalent to Quetiapine 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturers: Merck SL, Barcelona, Spain
Mylan Laboratories Limited, Maharashtra State, India
Product: Quetapel
Active Ingredient: Quetiapine fumarate 115.13mg equivalent to Quetiapine 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturers: Merck SL, Barcelona, Spain
Mylan Laboratories Limited, Maharashtra State, India
Product: Quetapel
Active Ingredient: Quetiapine fumarate 172.69mg equivalent to Quetiapine 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturers: Merck SL, Barcelona, Spain
Mylan Laboratories Limited, Maharashtra State, India
Product: Quetapel
Active Ingredient: Quetiapine fumarate 230.26mg equivalent to Quetiapine 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturers: Merck SL, Barcelona, Spain
Mylan Laboratories Limited, Maharashtra State, India
Product: Quetapel
Active Ingredient: Quetiapine fumarate 345.39mg equivalent to Quetiapine 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturers: Merck SL, Barcelona, Spain
Mylan Laboratories Limited, Maharashtra State, India
Dated this 17th day of July 2014.
STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).