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: Desmopressin PH&T
Active Ingredient: Desmopressin acetate 0.6mg equivalent to desmopressin 0.089mg/mL
Dosage Form: Nasal spray solution
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: MIPHARM S.p.A, Milano, Italy
Product: m-cefazolin
Active Ingredient: Cephazolin sodium 2.096g equivalent to cefazolin 2g
Dosage Form: Powder for injection
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Laboratorio Reig Jofre SA, Sant Adria de Besos, Barcelona, Spain
Product: m-Cefazolin
Active Ingredient: Cephazolin sodium 1.048g equivalent cefazolin 1g
Dosage Form: Powder for injection
New Zealand Sponsor: Multichem NZ Limited
Manufacturers: Laboratorio Reig Jofre SA, Sant Adria de Besos, Barcelona, Spain
Laboratorio Reig Jofre SA, Sant Joan Despi, Barcelona, Spain
Product: m-cefazolin
Active Ingredient: Cephazolin sodium 524mg equivalent to cefazolin 500mg
Dosage Form: Powder for injection
New Zealand Sponsor: Multichem NZ Limited
Manufacturers: Laboratorio Reig Jofre SA, Sant Adria de Besos, Barcelona, Spain
Laboratorio Reig Jofre SA, Sant Joan Despi, Barcelona, Spain
Product: m-Fluconazole
Active Ingredient: Fluconazole 100mg
Dosage Form: Capsule
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Pharmathen SA, Pallini, Attikis, Greece
Product: m-Fluconazole
Active Ingredient: Fluconazole 150mg
Dosage Form: Capsule
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Pharmathen SA, Pallini, Attikis, Greece
Product: m-Fluconazole
Active Ingredient: Fluconazole 200mg
Dosage Form: Capsule
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Pharmathen SA, Pallini, Attikis, Greece
Product: m-Fluconazole
Active Ingredient: Fluconazole 50mg
Dosage Form: Capsule
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Pharmathen SA, Pallini, Attikis, Greece
Product: Mylanta Double Strength
Active Ingredients: Aluminium hydroxide 400mg
Magnesium hydroxide 400mg
Simeticone 40mg
Dosage Form: Tablet
New Zealand Sponsor: Pfizer Consumer Healthcare Div. of Pfizer New Zealand Limited
Manufacturer: Pfizer Laboratories (Pty) Limited, Retreat, Cape Town, South Africa
Product: Mylanta Original
Active Ingredients: Aluminium hydroxide 200mg
Magnesium hydroxide 200mg
Simeticone 20mg
Dosage Form: Tablet
New Zealand Sponsor: Pfizer Consumer Healthcare Div. of Pfizer New Zealand Limited
Manufacturer: Pfizer Laboratories (Pty) Limited, Retreat, Cape Town, South Africa
Product: Rubifen SR
Active Ingredient: Methylphenidate hydrochloride 20mg
Dosage Form: Modified release tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Laboratorios Rubio SA, Castellbisbal, Barcelona, Spain
Product: Total Care One
Active Ingredients: Trometamol 12mg/mL
Tyloxapol 0.25mg/mL
Dosage Form: Contact lens solution
New Zealand Sponsor: Advanced Medical Optics Australia Pty Limited
Manufacturer: Advanced Medical Optics (Hangzhou) Co Limited, Hangzhou, Zhejiang, China
Product: Tramal Oral Drops
Active Ingredien: Tramadol hydrochloride 100mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: CSL New Zealand Limited
Manufacturer: Grunenthal GmbH, Stolberg, Germany
Dated this 26th day of September 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).