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: Arrow - Cabergoline
Active Ingredient: Cabergoline 0.5mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Laboratories Limited, Croydon, Victoria, Australia
Product: Beclazone 100 CFC-Free Inhaler
Active Ingredient: Beclometasone dipropionate 100µg
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: Norton Healthcare Limited (NZ Branch Office)
Manufacturer: Norton (Waterford) Limited, t/a Ivax Pharmaceuticals Ireland, Waterford, Ireland
Product: Beclazone 250 CFC-Free Inhaler
Active Ingredient: Beclometasone dipropionate 250µg
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: Norton Healthcare Limited (NZ Branch Office)
Manufacturer: Norton (Waterford) Limited, t/a Ivax Pharmaceuticals Ireland, Waterford, Ireland
Product: Beclazone 50 CFC-Free Inhaler
Active Ingredient: Beclometasone dipropionate 50µg
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: Norton Healthcare Limited (NZ Branch Office)
Manufacturer: Norton (Waterford) Limited, t/a Ivax Pharmaceuticals Ireland, Waterford, Ireland
Product: Cialis
Active Ingredient: Tadalafil 2.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: Lilly del Caribe, Inc., Carolina, Puerto Rico
Product: Cialis
Active Ingredient: Tadalafil 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: Lilly del Caribe, Inc., Carolina, Puerto Rico
Product: Colgate Total 12 Advanced Fresh
Active Ingredients: Sodium fluoride 0.22%w/w
Triclosan 0.3%w/w
Dosage Form: Toothpaste
New Zealand Sponsor: Colgate-Palmolive Limited
Manufacturer: Colgate-Palmolive (Thailand) Limited, Amphur Muang, Chonburi, Thailand
Product: Colgate Total 12 Mint Stripe
Active Ingredients: Sodium fluoride 0.22%w/w
Triclosan 0.3%w/w
Dosage Form: Toothpaste
New Zealand Sponsor: Colgate-Palmolive Limited
Manufacturer: Colgate-Palmolive (Thailand) Limited, Amphur Muang, Chonburi, Thailand
Product: Colgate Total 12 Whitening
Active Ingredients: Sodium fluoride 0.22%w/w
Triclosan 0.3%w/w
Dosage Form: Toothpaste
New Zealand Sponsor: Colgate-Palmolive Limited
Manufacturer: Colgate-Palmolive (Thailand) Limited, Amphur Muang, Chonburi, Thailand
Product: Colgate Total 12
Active Ingredients: Sodium fluoride 0.22%w/w
Triclosan 0.3%w/w
Dosage Form: Toothpaste
New Zealand Sponsor: Colgate-Palmolive Limited
Manufacturer: Colgate-Palmolive (Thailand) Limited, Amphur Muang, Chonbur, Thailand
Product: Fexofenadine
Active Ingredient: Fexofenadine hydrochloride 30mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Affordable Healthcare Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Generics, Bachepelli, Andhra Pradesh, India
Product: Ibuprofen
Active Ingredient: Ibuprofen 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: IPCA Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India
Product: Ibuprofen
Active Ingredient: Ibuprofen 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Manufacturing Division, District Raigad, (Maharashtra), India
Product: Lemsip Max Cold & Flu + Chesty Cough (Lemon & Menthol flavour)
Active Ingredients: Guaifenesin 200mg
Paracetamol 1,000mg
Phenylephrine hydrochloride 12.2mg equivalent to 10mg phenylephrine
Dosage Form: Powder for oral solution
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare (UK) Limited, Hull, North Humberside, United Kingdom
Product: Lemsip Max Cold & Flu + Chesty Cough (Wild Berry and Hot Orange flavour)
Active Ingredients: Guaifenesin 200mg
Paracetamol 1,000mg
Phenylephrine hydrochloride 12.2mg equivalent to 10mg phenylephrine
Dosage Form: Powder for oral solution
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare (UK) Limited, Hull, North Humberside, United Kingdom
Product: Micolette
Active Ingredients: Sodium citrate, anhydrous 90mg/mL
Sodium lauryl sulfoacetate 9mg/mL
Sorbitol 624mg/mL
Dosage Form: Enema
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland
Product: Omeprazole Infusion 40 mg
Active Ingredient: Omeprazole 40mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Affordable Healthcare Limited
Manufacturer: Sofarimex Industria Quimica e Farmaceutica Lda, Agualva, Cacem, Portugal
Product: Tredaptive
Active Ingredients: Laropiprant 20mg
Nicotinic acid 1,000mg
Dosage Form: Tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: MSD Technology Singapore PTE Limited, Singapore
Product: Yaz
Active Ingredients: Drospirenone 3mg
Ethinylestradiol betadex clathrate equivalent to ethinylestradiol 0.02mg
Dosage Form: Tablet
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Schering GmbH und Co Produktions KG, Weimar, Germany
Dated this 22nd day of August 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).