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 set out in the Schedule hereto:
Schedule
Product: Apo-Quetiapine
Active Ingredient: Quetiapine fumarate 28.8mg equivalent to Quetiapine 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Quetiapine
Active Ingredient: Quetiapine fumarate 115.1mg equivalent to Quetiapine 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Quetiapine
Active Ingredient: Quetiapine fumarate 172.6mg equivalent to Quetiapine 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Quetiapine
Active Ingredient: Quetiapine fumarate 230.1mg equivalent to Quetiapine 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Quetiapine
Active Ingredient: Quetiapine fumarate 345.2mg equivalent to Quetiapine 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Phosex
Active Ingredient: Calcium acetate 1025mg equivalent to Elemental calcium 250mg
Dosage Form: Tablet
New Zealand Sponsor: Max Health Limited
Manufacturer: Enzymatic Therapy Inc, Wisconsin, United States of America
Product: Venlafaxine XR
Active Ingredient: Venlafaxine hydrochloride 84.869mg equivalent to Venlafaxine 75mg
Dosage Form: Modified release capsule
New Zealand Sponsor: PSM Healthcare Limited trading as API Consumer Brands
Manufacturer: Wockhardt Limited, Maharashatra State, India
Product: Venlafaxine XR
Active Ingredient: Venlafaxine hydrochloride 169.738mg equivalent to Venlafaxine 150mg
Dosage Form: Modified release capsule
New Zealand Sponsor: PSM Healthcare Limited trading as API Consumer Brands
Manufacturer: Wockhardt Limited, Maharashatra State, India
Dated this 16th day of February 2012.
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).