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: Allerid C
Active Ingredient: Cetirizine hydrochloride 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Cipla Limited, Patalganga Industrial Area, District Raigad, (Maharashtra), India
Product: Duro-Tuss Chesty Forte Oral Liquid
Active Ingredients: Bromhexine hydrochloride 0.8mg/mL
Guaiphenesin 20mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: 3M New Zealand Limited
Manufacturer: Soul Pattinson Manufacturing Pty Limited, Kingsgrove, New South Wales, Australia
Product: Duro-Tuss Junior Chesty Oral Liquid
Active Ingredients: Bromhexine hydrochloride 0.8mg/mL
Guaiphenesin 20mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: 3M New Zealand Limited
Manufacturer: Soul Pattinson Manufacturing Pty Limited, Kingsgrove, New South Wales, Australia
Product: Gynol II Vaginal Contraceptive Jelly
Active Ingredient: Nonoxinol 9 20mg/g
Dosage Form: Vaginal gel
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer: Cilag AG, Schaffhausen, Switzerland
Product: Meningitec
Active Ingredients: Diphtheria CRM 197 protein conjugate 15Ág/dose
Meningococcal oligosaccharide - Group C 10Ág/dose
Dosage Form: Suspension for injection
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer: Berna Biotech AG, Berne, Switzerland
Product: Metamucil Orange Flavour Original Texture
Active Ingredient: Ispaghula husk 31.28%w/w
Dosage Form: Powder for oral solution
New Zealand Sponsor: Procter & Gamble Distributing New Zealand
Manufacturer: Procter & Gamble Pharmaceuticals, Phoenix, Arizona, United States of America
Product: Micozole
Active Ingredient: Miconazole nitrate 20mg/g
Dosage Form: Topical cream
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Taro Pharmaceuticals Inc., Bramelea, Ontario, Canada
Product: Nicotrol Mint
Active Ingredient: Nicotine 2mg
Dosage Form: Chewing gum
New Zealand Sponsor: Pharmacia Limited Company trading as Pharmacia
Manufacturers: Pharmacia AB, Helsingborg, Sweden
Scan-Gum Aps, Esbjerg, Denmark
Product: Nicotrol Mint
Active Ingredient: Nicotine 4mg
Dosage Form: Chewing gum
New Zealand Sponsor: Pharmacia Limited Company trading as Pharmacia
Manufacturers: Pharmacia AB, Helsingborg, Sweden
Scan-Gum Aps, Esbjerg, Denmark
Product: Nicotrol
Active Ingredient: Nicotine 2mg
Dosage Form: Chewing gum
New Zealand Sponsor: Pharmacia Limited Company trading as Pharmacia
Manufacturers: Pharmacia AB, Helsingborg, Sweden
Scan-Gum Aps, Esbjerg, Denmark
Product: Nicotrol
Active Ingredient: Nicotine 4mg
Dosage Form: Chewing gum
New Zealand Sponsor: Pharmacia Limited Company trading as Pharmacia
Manufacturers: Pharmacia AB, Helsingborg, Sweden
Scan-Gum Aps, Esbjerg, Denmark
Product: Parasidose
Active Ingredient: Phenothrin 0.5%w/w
Dosage Form: Shampoo
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Laboratoires Gilbert, Herouville-Saint-Clair Cedex, France
Product: Zetop
Active Ingredient: Cetirizine hydrochloride 10mg
Dosage Form: Tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Cadila Pharmaceuticals Limited, Dholka, District Ahmedabad, Gujarat State, India
Dated this 27th day of March 2003.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).