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: Calcitriol-AFT
Active Ingredient: Calcitriol 0.25µg
Dosage Form: Liquid filled capsule
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Swiss Caps AG, Kirchberg, Switzerland
Product: Calcitriol-AFT
Active Ingredient: Calcitriol 0.5µg
Dosage Form: Liquid filled capsule
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Swiss Caps AG, Kirchberg, Switzerland
Product: Lamisil Jock Itch DermGel
Active Ingredient: Terbinafine 1%w/w
Dosage Form: Topical gel
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited
Manufacturers: Novartis Consumer Health SA, Prangins, Nyon, Switzerland
Novartis Pharma Produktions GmbH, Wehr, Germany
Product: Lemsip Max Cold & Flu Capsules
Active Ingredients: Paracetamol 500mg
Phenylephrine hydrochloride 6.1mg
Dosage Form: Combination capsule
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturers: Perrigo UK Limited, Wrafton, Braunton, United Kingdom
Reckitt Benckiser Healthcare (UK) Limited, Hull, North Humberside, United Kingdom
Product: LoraZene
Active Ingredient: Loratadine 10mg
Dosage Form: Tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Sigma Laboratories, Sinnar, Nashik, Maharashta, India
Product: Methotrexate Ebewe
Active Ingredient: Methotrexate 100mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: InterPharma Pty Limited
Manufacturer: EBEWE Pharma GmbH Nfg KG, Unterach am Attersee, Austria
Product: m-Isoflurane
Active Ingredient: Isoflurane 100%
Dosage Form: Solution for inhalation
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Halocarbon Laboratories, North Augusta, United States of America
Product: NicabateCQ Soft Gum
Active Ingredient: Nicotine polacrilex 11.78mg equivalent to nicotine 2mg
Dosage Form: Chewing gum
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Fertin Pharma A/S, Vejle, Denmark
Product: NicabateCQ Soft Gum
Active Ingredient: Nicotine polacrilex 23.56mg equivalent to nicotine 4mg
Dosage Form: Chewing gum
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Fertin Pharma A/S, Vejle, Denmark
Product: Nicorette Freshmint Gum
Active Ingredient: Nicotine 2mg
Dosage Form: Chewing gum
New Zealand Sponsor: Pfizer Consumer Healthcare Div. of Pfizer New Zealand Limited
Manufacturer: Pfizer Health AB, Helsingborg, Sweden
Product: Nicorette Freshmint Gum
Active Ingredient: Nicotine 4mg
Dosage Form: Chewing gum
New Zealand Sponsor: Pfizer Consumer Healthcare Div. of Pfizer New Zealand Limited
Manufacturer: Pfizer Health AB, Helsingborg, Sweden
Product: Nicotrol Freshmint Gum
Active Ingredient: Nicotine 2mg
Dosage Form: Chewing gum
New Zealand Sponsor: Pfizer Consumer Healthcare Div. of Pfizer New Zealand Limited
Manufacturer: Pfizer Health AB, Helsingborg, Sweden
Product: Nicotrol Freshmint Gum
Active Ingredient: Nicotine 4mg
Dosage Form: Chewing gum
New Zealand Sponsor: Pfizer Consumer Healthcare Div. of Pfizer New Zealand Limited
Manufacturer: Pfizer Health AB, Helsingborg, Sweden
Product: Paracetamol
Active Ingredient: Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: REX Medical Limited
Manufacturers: Cipla Ltd, Manufacturing Division Plot D-22, Kurkumbh Village, Takula-Daund, District-Pune, Maharashtra State, India
Cipla Ltd, Manufacturing Division Plot D-7, Kurkumbh Village, Takula-Daund, District-Pune, Maharashtra State, India
Product: SimvaRex
Active Ingredient: Simvastatin 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Manufacturing Division, Kurkumbh Village, Taluka - Daund, District - Pune, Maharashtra State, India
Product: Simvastatin - Rex
Active Ingredient: Simvastatin 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Manufacturing Division, Kurkumbh Village, Taluka - Daund, District - Pune, Maharashtra State, India
Product: Simvastatin - Rex
Active Ingredient: Simvastatin 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Manufacturing Division, Kurkumbh Village, Taluka - Daund, District - Pune, Maharashtra State, India
Product: Simvastatin - Rex
Active Ingredient: Simvastatin 40mg
Dosage Form: Film coated tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Manufacturing Division, Kurkumbh Village, Taluka - Daund, District - Pune, Maharashtra State, India
Product: Vistil Forte
Active Ingredient: Polyvinyl alcohol 3%w/v
Dosage Form: Eye drops, solution
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Tubilux Pharma SpA, Pomezia, Rome, Italy
Dated this 5th day of January 2006.
CYNTHIA MALING, Acting-Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on the 6th day of July 2001).