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: Bepanthen First Aid
Active Ingredient: Chlorhexidine hydrochloride 5.5mg/g
Dosage Form: Topical cream
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: GP Grenzach Producktions GmbH, Grenzach-Wyhlen, Germany
Product: DBL® Ceftazidime
Active Ingredient: Ceftazidime pentahydrate 1.164g equivalent to 1g Ceftazidime
Dosage Form: Powder for injection
New Zealand Sponsor: Mayne Pharma (NZ) Limited
Manufacturers: Anfarm Hellas SA, Schimatari, Greece
Facta Farmaceutica SpA, Nucleo Industriale S. Teramo, Italy
Product: DBL® Ceftazidime
Active Ingredient: Ceftazidime pentahydrate 2.328g equivalent to Ceftazidime 2g
Dosage Form: Powder for injection
New Zealand Sponsor: Mayne Pharma (NZ) Limited
Manufacturers: Anfarm Hellas SA, Schimatari, Greece
Facta Farmaceutica SpA, Nucleo Industriale S. Teramo, Italy
Product: Efexor-XR
Active Ingredient: Venlafaxine hydrochloride 42.43mg equivalent to 37.5mg venlafaxine
Dosage Form: Modified release capsule
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturers: Wyeth Medica Ireland, Little Connell, Newbridge, County Kildare, Ireland
Wyeth Pharmaceuticals Company, Barrios Pozo Hondos & Jobos, Guayama, Puerto Rico
Product: Fluticasone Nasal Spray
Active Ingredient: Fluticasone propionate 0.05%w/w
Dosage Form: Nasal spray suspension
New Zealand Sponsor: SFY Limited
Manufacturers: Cipla Limited, Verna Industrial Area,, Salcette, Goa, India
Product: Physioneal 35
Active Ingredients: Calcium chloride dihydrate 0.257g/L
Glucose monohydrate 15g/L equivalent to 13.6g/l glucose anhydrate
Magnesium chloride hexahydrate 0.051g/L
Sodium bicarbonate 2.1g/mL
Sodium chloride 5.67g/mL
Sodium lactate 1.12g/mL
Dosage Form: Dialysis solution
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter Healthcare SA, Castlebar, County Mayo, Ireland
Product: Physioneal 35
Active Ingredients: Calcium chloride dihydrate 0.257g/L
Glucose monohydrate 25g/L equivalent to 22.7g/L anhydrous glucose
Magnesium chloride hexahydrate 0.051g/L
Sodium bicarbonate 2.1g/L
Sodium chloride 5.67g/L
Sodium lactate 1.12g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter Healthcare SA, Castlebar, County Mayo, Ireland
Product: Physioneal 35
Active Ingredients: Calcium chloride dihydrate 0.257g/L
Glucose monohydrate 42.5g/L equivalent to 38.6g/L anhydrous glucose
Magnesium chloride hexahydrate 0.051g/L
Sodium bicarbonate 2.1g/L
Sodium chloride 5.67g/L
Sodium lactate 1.12g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter Healthcare SA, Castlebar, County Mayo, Ireland
Product: Physioneal 40
Active Ingredients: Calcium chloride dihydrate 0.184g/L
Glucose monohydrate 15g/L equivalent to 13.6g/L anhydrous glucose
Magnesium chloride hexahydrate 0.051g/L
Sodium bicarbonate 2.1g/L
Sodium chloride 5.38g/L
Sodium lactate 1.68g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter Healthcare SA, Castlebar, County Mayo, Ireland
Product: Physioneal 40
Active Ingredients: Calcium chloride dihydrate 0.184g/L
Glucose monohydrate 25g/L equivalent to 22.7g/L anhydrous glucose
Magnesium chloride hexahydrate 0.051g/L
Sodium bicarbonate 2.1g/L
Sodium chloride 5.38g/L
Sodium lactate 1.68g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter Healthcare SA, Castlebar, County Mayo, Ireland
Product: Physioneal 40
Active Ingredients: Calcium chloride dihydrate 0.184g/L
Glucose monohydrate 42.5g/L equivalent to 38.6g/L anhydrous glucose
Magnesium chloride hexahydrate 0.051g/L
Sodium bicarbonate 2.1g/L
Sodium chloride 5.38g/L
Sodium lactate 1.68g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter Healthcare SA, Castlebar, County Mayo, Ireland
Dated this 22nd day of February 2007.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).