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-Escitalopram
Active Ingredient: Escitalopram oxalate 6.38mg equivalent to escitalopram 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Escitalopram
Active Ingredient: Escitalopram oxalate 12.77mg equivalent to escitalopram 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Escitalopram
Active Ingredient: Escitalopram oxalate 19.16mg equivalent to escitalopram 15mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Escitalopram
Active Ingredient: Escitalopram oxalate 25.54mg equivalent to escitalopram 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: APO-Imiquimod
Active Ingredient: Imiquimod 12.5mg
Dosage Form: Topical cream
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Zyg Pharma Pvt. Limited, Andhra Pradesh, India
Product: Auro-Cefazolin 0.5g
Active Ingredient: Cefazolin sodium 524mg equivalent to cefazolin 500mg
Dosage Form: Powder for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Andhra Pradesh, India
Product: Auro-Cefazolin 1g
Active Ingredient: Cefazolin sodium 1048mg equivalent to cefazolin 1000mg
Dosage Form: Powder for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Andhra Pradesh, India
Product: Auro-Cefazolin 2g
Active Ingredient: Cefazolin sodium 2096mg equivalent to cefazolin 2000mg
Dosage Form: Powder for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Andhra Pradesh, India
Product: Cefazolin Pfizer
Active Ingredient: Cefazolin sodium 524mg equivalent to cefazolin 500mg
Dosage Form: Powder for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Andhra Pradesh, India
Product: Cefazolin Pfizer
Active Ingredient: Cefazolin sodium 1048mg equivalent to cefazolin 1000mg
Dosage Form: Powder for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Andhra Pradesh, India
Product: Cefazolin Pfizer
Active Ingredient: Cefazolin sodium 2096mg equivalent to cefazolin 2000mg
Dosage Form: Powder for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Andhra Pradesh, India
Product: Deep Heat Arthritis Relief
Active Ingredients: Menthol 8%w/w
Methyl salicylate 30%w/w
Dosage Form: Topical cream
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Mentholatum Australasia Pty Limited, Scoresby, Australia
Product: Instillagel
Active Ingredients: Chlorhexidine gluconate 0.52mg/mL
Lidocaine hydrochloride, anhydrous 19.6mg/mL
Dosage Form: Topical gel
New Zealand Sponsor: MD Solutions NZ Limited
Manufacturer: Klosterfrau Berlin GmbH, Berlin, Germany
Product: Losartan HCTad
Active Ingredients: Hydrochlorothiazide 12.5mg
Losartan potassium 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturer: KRKA d d Novo mesto, Novo mesto, Slovenia
Dated this 15th day of September 2011.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).