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: DP Fusidic Acid Cream
Active Ingredients: Fusidic acid 20.35mg/g
Dosage Form: Topical cream
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Basic Pharma Manufacturing BV, Geleen, The Netherlands
Product: First Response 7 Day Pregnancy Planning Kit
Active Ingredients: Antibody to HCG hormone 0.06mcg
Goat anti-mouse immunoglobulin G polyclonal antibody 0.4mcg
Murine monoclonal antibody to HCG 0.3mcg
Dosage Form: Pregnancy test kit
New Zealand Sponsor: Pharmabroker Sales Limited
Manufacturer: Scantibodies Laboratory Inc., California, United States of America
Product: Hexaxim
Active Ingredients: Diphtheria toxoid, adsorbed 30Lf U equivalent to not less than 20IU
Haemophilus influenzae type b polysaccharide 12mcg
Hepatitis B virus surface antigen 10mcg
Pertussis filamentous haemagglutinin 25mcg
Pertussis toxoid, adsorbed 25mcg
Polio virus type 1 40DAgU
Polio virus type 2 8DAgU
Polio virus type 3 32DAgU
Tetanus toxoid, adsorbed 10Lf U equivalent to not less than 40IU
Dosage Form: Suspension for injection
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi Pasteur SA, Marcy L'Etoile, France
Product: Riodine Povidone-Iodine Antiseptic Solution
Active Ingredient: Povidone-iodine 100mg/mL equivalent to Iodine 1.0% w/v
Dosage Form: Topical solution
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: Orion Laboratories Pty Limited, Perth, Australia
Product: Stribild
Active Ingredients: Cobicistat 150mg
Elvitegravir 150mg
Emtricitabine 200mg
Tenofovir disoproxil fumarate 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Gilead Sciences (NZ)
Manufacturer: Patheon Inc, Ontario, Canada
Dated this 28th day of February 2014.
STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).