Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the schedule hereto:
Schedule
Product: Accolate
Active Ingredient(s): Zafirlukast 20mg
Dosage Form: Tablet
NZ Sponsor: AstraZeneca Limited
Manufacturer(s): Zeneca Pharmaceuticals, Macclesfield, Cheshire, United Kingdom
Product: Accolate
Active Ingredient(s): Zafirlukast 40mg
Dosage Form: Tablet
NZ Sponsor: AstraZeneca Limited
Manufacturer(s): Zeneca Pharmaceuticals, Macclesfield, Cheshire, United Kingdom
Product: Apo-Acyclovir
Active Ingredient(s): Aciclovir 200mg
Dosage Form: Tablet
NZ Sponsor: Apotex (NZ) Limited
Manufacturer(s): Apotex Inc, Weston, Ontario, Canada
Product: Apo-Acyclovir
Active Ingredient(s): Aciclovir 400mg
Dosage Form: Tablet
NZ Sponsor: Apotex (NZ) Limited
Manufacturer(s): Apotex Inc, Weston, Ontario, Canada
Product: Apo-Acyclovir
Active Ingredient(s): Aciclovir 800mg
Dosage Form: Tablet
NZ Sponsor: Apotex (NZ) Limited
Manufacturer(s): Apotex Inc, Weston, Ontario, Canada
Product: Asmanex Twisthaler
Active Ingredient(s): Mometasone furoate 200µg/dose
Dosage Form: Powder for inhalation
NZ Sponsor: Schering-Plough Pty Limited
Manufacturer(s): Schering-Plough Limited, Singapore
Product: Asmanex Twisthaler
Active Ingredient(s): Mometasone furoate 400µg/dose
Dosage Form: Powder for inhalation
NZ Sponsor: Schering-Plough Pty Limited
Manufacturer(s): Schering-Plough Limited, Singapore
Product: Clomhexal
Active Ingredient(s): Clomiphene citrate 50mg
Dosage Form: Tablet
NZ Sponsor: Hexal New Zealand Limited
Manufacturer(s): Heumann Pharma GmbH (Manufacturing Facility), Plant II, Feucht, Germany
Salutas Pharma GmbH, Barleben, Germany
Product: Zolaten
Active Ingredient(s): Aciclovir 5%w/w
Dosage Form: Topical cream
NZ Sponsor: Pharmaco (NZ) Limited
Manufacturer(s): Chefaro International BV, Rotterdam, The Netherlands
Dated this 12th day of January 2000.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).