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-Fluticasone
Active Ingredient: Fluticasone propionate 0.5g/kg
Dosage Form: Nasal spray solution
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Richmond Hill, Ontario, Canada
Product: Enlafax XR
Active Ingredient: Venlafaxine hydrochloride 169.71mg equivalent to venlafaxine 150mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturer: Pharmathen SA, Pallini, Attikis, Greece
Product: Enlafax XR
Active Ingredient: Venlafaxine hydrochloride 42.43mg equivalent to venlafaxine 37.5mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturer: Pharmathen SA, Pallini, Attikis, Greece
Product: Enlafax XR
Active Ingredient: Venlafaxine hydrochloride 84.86mg equivalent to venlafaxine 75mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturer: Pharmathen SA, Pallini, Attikis, Greece
Product: Fluoxetine
Active Ingredient: Fluoxetine hydrochloride 22.36mg equivalent to 20mg Fluoxetine
Dosage Form: Capsule
New Zealand Sponsor: Affordable Healthcare Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Generics, Bachupally, Andhra Pradesh, India
Dated this 9th day of March 2009.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).