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: Calcitriol
Active Ingredient: Calcitriol 0.25µg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Norton Healthcare Limited (NZ Branch Office)
Manufacturer: R P Scherer & Co. KG., Eberbach/Baden, Germany
Product: Calcitriol
Active Ingredient: Calcitriol 0.5µg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Norton Healthcare Limited (NZ Branch Office)
Manufacturer: R P Scherer & Co. KG., Eberbach/Baden, Germany
Product: Ginet 63
Active Ingredients: Cyproterone acetate 2mg
Ethinylestradiol 0.035mg
Dosage Form: Film coated tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Manufacturing Division, District Raigad, (Maharashtra), India
Product: Ginet 84
Active Ingredients: Cyproterone acetate 2mg
Ethinylestradiol 0.035mg
Dosage Form: Film coated tablet
New Zealand Sponsor: REX Medical Limited
Manufacturers: Cipla Limited, Manufacturing Division, District Raigad, (Maharashtra), India
Product: Risperidone
Active Ingredient: Risperidone 1mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Affordable Healthcare Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Generics, Bachupally, Andhra Pradesh, India
Product: Risperidone
Active Ingredient: Risperidone 2mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Affordable Healthcare Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Generics, Bachupally, Andhra Pradesh, India
Product: Risperidone
Active Ingredient: Risperidone 3mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Affordable Healthcare Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Generics, Bachupally, Andhra Pradesh, India
Product: Risperidone
Active Ingredient: Risperidone 4mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Affordable Healthcare Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Generics, Bachupally, Andhra Pradesh, India
Product: Sprycel
Active Ingredient: Dasatinib 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Bristol-Myers Squibb Company, Mt Vernon, Indiana, United States of America
Product: Sprycel
Active Ingredient: Dasatinib 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Bristol-Myers Squibb Company, Mt Vernon, Indiana, United States of America
Product: Sprycel
Active Ingredient: Dasatinib 70mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Bristol-Myers Squibb Company, Mt Vernon, Indiana, United States of America
Product: Water for Injections Freeflex
Active Ingredient: Water for injection 100%
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmatel Fresenius Kabi NZ Limited c/- Fresenius Medical Care Australia NZ Pty Limited
Manufacturer: Fresenius Kabi Norge AS, Berg-i-Ostfold, Halden, Norway
Dated this 1st day of May 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).