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: Fleet Enema
Active Ingredients: Dibasic sodium phosphate, anhydrous 10%w/v
Phosphoric acid 6.58%w/v
Dosage Form: Enema
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: CB Fleet & Co Inc, Lynchburg, Virginia, United States of America
Product: NovoMix 50 Flexpen
Active Ingredient: Insulin aspart 100IU/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Product: NovoMix 50 Penfill
Active Ingredient: Insulin aspart 100IU/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Product: NovoMix 70 Flexpen
Active Ingredient: Insulin aspart 100IU/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Product: NovoMix 70 Penfill
Active Ingredient: Insulin aspart 100IU/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Product: Tamsulosin-Rex
Active Ingredient: Tamsulosin hydrochloride 0.4mg
Dosage Form: Modified release capsule
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Manufacturing & Research Div., Virgonagar, Old Madras Road, Bangalore, India
Product: Tisseel Duo 500
Active Ingredients: Aprotinin 3,000kIU
Factor XIII 10 – 50U in Total Protein Solution
Fibrinogen 70 – 100mg/mL in Total Protein Solution
Plasma protein fraction as Plasma fibronectin 2 – 9mg/mL in Total Protein solution
Plasminogen 40 – 120µg/mL in Total Protein solution
Dosage Form: Syringe 1 Topical solution
Active Ingredients: Calcium chloride dihydrate 40µmol/mL
Thrombin 500IU/mL
Dosage Form: Syringe 2 Topical solution
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter AG, Vienna, Austria
Dated this 29th day of February 2008.
JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).