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-Amlodipine
Active Ingredient: Amlodipine besilate 14mg equivalent to 10mg amlodipine
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, 50 Steinway Boulevard, Etobicoke, Ontario, Canada
Product: Apo-Amlodipine
Active Ingredient: Amlodipine besilate 7mg equivalent to 5mg amlodipine
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, 50 Steinway Boulevard, Etobicoke, Ontario, Canada
Product: Asthalin
Active Ingredient: Salbutamol sulphate 1.2mg/mL equivalent to salbutamol 1mg/mL
Dosage Form: Solution for inhalation
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Ltd, Plot No S-103, S-104 and L-139 to L-146, Verna Industrial Area, Salcette, Goa, India
Product: Asthalin
Active Ingredient: Salbutamol sulphate 2.4mg/mL equivalent to salbutamol 2mg/mL
Dosage Form: Solution for inhalation
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Ltd, Plot No S-103, S-104 and L-139 to L-146, Verna Industrial Area, Salcette, Goa, India
Product: Canesten Fluconazole Capsule & Clotrimazole Cream Duo (Combination Product)
Active Ingredient: Fluconazole 150mg
Dosage Form: Capsule
Manufacturer: Genpharm Inc., 37 Advance Road, Etobicoke, Ontario, Canada
Active Ingredient: Clotrimazole 10mg/g
Dosage Form: Topical cream
Manufacturer: Kern Pharma SL, Poligono Industrial Colon II, c/- Venus 72, Terrassa, Barcelona, Spain
New Zealand Sponsor: Bayer New Zealand Limited
Product: Fluconazole - Rex
Active Ingredient: Fluconazole 150mg
Dosage Form: Capsule
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Ltd, Manufacturing Division, Plot No. D-7, MIDC Industrial Area, Kurkumbh Village, Taluka - Daund, District - Pune, Maharashtra State, India
Product: Fluconazole - Rex
Active Ingredient: Fluconazole 200mg
Dosage Form: Capsule
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Ltd, Manufacturing Division, Plot No. D-7, MIDC Industrial Area, Kurkumbh Village, Taluka - Daund, District - Pune, Maharashtra State, India
Product: Fluconazole - Rex
Active Ingredient: Fluconazole 50mg
Dosage Form: Capsule
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Ltd, Manufacturing Division, Plot No. D-7, MIDC Industrial Area, Kurkumbh Village, Taluka - Daund, District - Pune, Maharashtra State, India
Product: Nurofen For Children Meltlets
Active Ingredient: Ibuprofen 100mg
Dosage Form: Tablet-orally disintregating
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturers: Ethypharm Industries, Zone Indust. de Saint-Arnault, 28170 Chateuneuf-en-Thymerais, France
Reckitt Benckiser Healthcare International Limited, Nottingham Site, Thane Road, Nottingham, Nottinghamshire, United Kingdom
Product: Nurofen Meltlets Lemon
Active Ingredient: Ibuprofen 200mg
Dosage Form: Tablet-orally disintregating
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturers: Ethypharm Industries, Zone Indust. de Saint-Arnault, 28170 Chateuneuf-en-Thymerais, France
Reckitt Benckiser Healthcare International Limited, Nottingham Site, Thane Road, Nottingham, Nottinghamshire, United Kingdom
Product: Nurofen Meltlets Mint
Active Ingredient: Ibuprofen 200mg
Dosage Form: Tablet-orally disintregating
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturers: Ethypharm Industries, Zone Indust. de Saint-Arnault, 28170 Chateuneuf-en-Thymerais, France
Reckitt Benckiser Healthcare International Limited, Nottingham Site, Thane Road, Nottingham, Nottinghamshire, United Kingdom
Product: Pentasa
Active Ingredient: Mesalazine 2g
Dosage Form: Modified release granules
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturers: Ferring A/S (Denmark), Indertoften 10, DK-2720, Vanlose, Denmark
Ferring International Centre SA, Chemin de la Vergognausaz, CH-1162 St-Prex, Switzerland
Inpac AB, Aldermansgatan 2, S-22100 Lund, Sweden
QPharma AB, Agneslundsvagen 27, Malmo, Sweden
Product: Rotarix
Active Ingredient: Rotavirus vaccine 1,000,000CCID50
Dosage Form: Powder for oral suspension
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Biologicals SA, Rue de l’Institut 89, Rixensart, Belgium
Product: Topicaine
Active Ingredients: Adrenaline acid tartrate 0.18%w/v
Lignocaine hydrochloride monohydrate 4%w/v
Tetracaine hydrochloride 0.5%w/v
Dosage Form: Topical solution
New Zealand Sponsor: Biomed Limited
Manufacturer: Biomed Limited, 52 Carrington Road, Pt Chevalier, Auckland
Dated this 14th day of December 2006.
MARK JACOBS, Acting Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health
on 6 July 2001).