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-Cilazapril
Active Ingredient: Cilazapril monohydrate 5.213mg equivalent to 5mg cilazapril
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Cilazapril
Active Ingredient: Cilazapril monohydrate 2.606mg equivalent to 2.5mg cilazapril
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Clarithromycin
Active Ingredient: Clarithromycin 250mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Clarithromycin
Active Ingredient: Clarithromycin 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Arrow-Isotretinoin 10
Active Ingredient: Isotretinoin 10mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: GAP S.A., Athens, Greece
Product: Arrow-Isotretinoin 20
Active Ingredient: Isotretinoin 20mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: GAP S.A., Athens, Greece
Product: Arrow-Isotretinoin 5
Active Ingredient: Isotretinoin 5mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: GAP S.A., Athens, Greece
Product: Bicalaccord
Active Ingredient: Bicalutamide 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Product: Invega Sustenna
Active Ingredient: Paliperidone palmitate 39mg equivalent to 25mg paliperidone base
Dosage Form: Suspension for injection
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen Pharmaceutica NV, Beerse, Belgium
Product: Invega Sustenna
Active Ingredient: Paliperidone palmitate 78mg equivalent to 50mg paliperidone base
Dosage Form: Suspension for injection
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen Pharmaceutica NV, Beerse, Belgium
Product: Invega Sustenna
Active Ingredient: Paliperidone palmitate 117mg equivalent to 75mg paliperidone base
Dosage Form: Suspension for injection
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen Pharmaceutica NV, Beerse, Belgium
Product: Invega Sustenna
Active Ingredient: Paliperidone palmitate 156mg equivalent to 100mg paliperidone base
Dosage Form: Suspension for injection
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen Pharmaceutica NV, Beerse, Belgium
Product: Invega Sustenna
Active Ingredient: Paliperidone palmitate 234mg equivalent to 150mg paliperidone base
Dosage Form: Suspension for injection
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen Pharmaceutica NV, Beerse, Belgium
Product: Paracetamol
Active Ingredient: Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Adcock Ingram Limited - A Medreich Group Company, Bangalore, India
Product: Prezista
Active Ingredient: Darunavir 400mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen Ortho LLC, Gurabo, Puerto Rico
Product: Prezista
Active Ingredient: Darunavir 600mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen Ortho LLC, Gurabo, Puerto Rico
Product: Univent
Active Ingredient: Ipratropium bromide monohydrate 250µg/mL
Dosage Form: Solution for inhalation
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Goa, India
Dated this 5th day of March 2010.
MARK RICHARDS, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).