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-Mirtazapine
Active Ingredient: Mirtazapine 15mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: APO-Mirtazapine
Active Ingredient: Mirtazapine 30mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: APO-Mirtazapine
Active Ingredient: Mirtazapine 45mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: AS-Gemcitabine
Active Ingredient: Gemcitabine hydrochloride 227.705mg equivalent to gemcitabine 200mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Saltarelo Holdings Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India
Product: AS-Gemcitabine
Active Ingredient: Gemcitabine hydrochloride 1138.53mg equivalent to gemcitabine 1000mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Saltarelo Holdings Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India
Product: AS-Gemcitabine
Active Ingredient: Gemcitabine hydrochloride 2227.05mg equivalent to gemcitabine 2000mg
Dosage Form: Powder for injection
New Zealand Sponsor: Saltarelo Holdings Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India
Product: Brinavess
Active Ingredient: Vernakalant hydrochloride 20mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Hameln Pharmaceuticals GmbH, Hameln, Germany
Product: DBL® Cefepime Powder for Injection
Active Ingredient: Cefepime dihydrochloride monohydrate 1g
Dosage Form: Powder for injection
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Hospira Healthcare India Pvt. Limited, Kancheepuram District, India
Product: DBL® Cefepime Powder for Injection
Active Ingredient: Cefepime dihydrochloride monohydrate 2g
Dosage Form: Powder for injection
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Hospira Healthcare India Pvt. Limited, Kancheepuram District, India
Product: Gemcitabine-PF
Active Ingredient: Gemcitabine hydrochloride 227.705mg equivalent to gemcitabine 200mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Saltarelo Holdings Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India
Product: Gemcitabine-PF
Active Ingredient: Gemcitabine hydrochloride 1138.53mg equivalent to gemcitabine 1000mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Saltarelo Holdings Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India
Product: Gemcitabine-PF
Active Ingredient: Gemcitabine hydrochloride 2227.05mg equivalent to gemcitabine 2000mg
Dosage Form: Powder for injection
New Zealand Sponsor: Saltarelo Holdings Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India
Product: GN-Gemcitabine
Active Ingredient: Gemcitabine hydrochloride 227.705mg equivalent to gemcitabine 200mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Saltarelo Holdings Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India
Product: GN-Gemcitabine
Active Ingredient: Gemcitabine hydrochloride 1138.53mg equivalent to gemcitabine 1000mg
Dosage Form: Powder for injection
New Zealand Sponsor: Saltarelo Holdings Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India
Product: GN-Gemcitabine
Active Ingredient: Gemcitabine hydrochloride 2227.05mg equivalent to gemcitabine 2000mg
Dosage Form: Powder for injection
New Zealand Sponsor: Saltarelo Holdings Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India
Product: Ibuprofen
Active Ingredient: Ibuprofen 200mg
Dosage Form: Coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Marksans Pharma Limited, Goa, India
Product: Octreotide MaxRx Injection
Active Ingredient: Octreotide acetate 0.056mg/mL equivalent to octreotide 50mcg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Max Health Limited
Manufacturer: GP-Pharm SA, Barcelona, Spain
Product: Octreotide MaxRx Injection
Active Ingredient: Octreotide acetate 0.112mg/mL equivalent to octreotide 100mcg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Max Health Limited
Manufacturer: GP-Pharm SA, Barcelona, Spain
Product: Octreotide MaxRx Injection
Active Ingredient: Octreotide acetate 0.56mg/mL equivalent to octreotide 500mcg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Max Health Limited
Manufacturer: GP-Pharm SA, Barcelona, Spain
Product: Omnaris
Active Ingredient: Ciclesonide 50µg
Dosage Form: Nasal spray solution
New Zealand Sponsor: Research Associates Limited
Manufacturer: Nycomed GmbH, Singen, Germany
Dated this 10th day of November 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).