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: Acnederm Medicated Lotion
Active Ingredient(s): Azelaic acid 20%w/w
Dosage Form: Lotion
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Ego Pharmaceuticals Pty Limited, Braeside, Victoria, Australia
Product: Benadryl Dry Cough & Nasal Congestion
Active Ingredient(s): Dextromethorphan hydrobromide 2mg/mL
Pseudoephedrine hydrochloride 6mg/mL
Dosage Form: Syrup
New Zealand Sponsor: Warner Lambert Consumer Group Div. of Pfizer Laboratories Limited
Manufacturer(s): Parke Davis Pty Limited, Caringbah, Sydney, New South Wales, Australia
Product: Cellufresh
Active Ingredient(s): Carmellose sodium 5mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Allergan New Zealand Limited
Manufacturer(s): Allergan Optical, Allergan Inc., Waco, Texas, United States of America
Product: Diflucan
Active Ingredient(s): Fluconazole 10mg/mL
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Pfizer Laboratories Limited
Manufacturer(s): Pfizer S.A., de Poce-sur-cisse, Amboise Cedex, France
Product: Diflucan
Active Ingredient(s): Fluconazole 40mg/mL
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Pfizer Laboratories Limited
Manufacturer(s): Pfizer S.A., de Poce-sur-cisse, Amboise Cedex, France
Product: E-Lyte
Active Ingredient(s): Citric acid (anhydrous) 384mg
Glucose (anhydrous) 1,620mg
Potassium chloride 186mg
Sodium bicarbonate 336mg
Sodium chloride 117mg
Dosage Form: Effervescent tablet
New Zealand Sponsor: Regional Health Limited
Manufacturer(s): E-Pharma Trento SpA, Ravina di Trento 38040, Italy
Product: Fungo
Active Ingredient(s): Miconazole nitrate 2%w/w
Dosage Form: Vaginal cream
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Ego Pharmaceuticals Pty Limited, Braeside, Victoria, Australia
Product: Glytrin
Active Ingredient(s): Glyceryl trinitrate 400µg/dose
Dosage Form: Sublingual spray
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer(s): Pharmasol Limited, Andover, Hampshire, United Kingdom
Note: This medicine is not interchangeable with any other glyceryl trinitrate spray.
Product: Micanol
Active Ingredient(s): Dithranol 1%w/w
Dosage Form: Topical cream
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer(s): Bioglan AB, Malmo, Sweden
Product: Oratane
Active Ingredient(s): Isotretinoin 10mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): SCA-Lohnherstellungs AG, Kirchberg, Switzerland
Note: Not to be marketed as substitutable for any other isotretinoin product as if the two products were bioequivalent.
Product: Propofol
Active Ingredient(s): Propofol 20mg/mL
Dosage Form: Emulsion for injection
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer(s): Abbott Laboratories Inc., Specialty Products Division, North Chicago, Illinois, United States of America
Abbott Laboratories SA, Madrid, Spain
Product: Puff (Cotton Candy)
Active Ingredient(s): Hydrofluoric acid 9.5mg/g
Sodium fluoride 18.5mg/g equivalent to 1.23%w/w fluoride ion
Dosage Form: Foam
New Zealand Sponsor: Ivoclar Vivadent Limited
Manufacturer(s): Pascal Company Inc, Bellevue, Washington, United States of America
Product: Puff (Peppy Mint)
Active Ingredient(s): Hydrofluoric acid 9.5mg/g
Sodium fluoride 18.5mg/g equivalent to 1.23%w/w fluoride ion
Dosage Form: Foam
New Zealand Sponsor: Ivoclar Vivadent Limited
Manufacturer(s): Pascal Company Inc, Bellevue, Washington, United States of America
Product: Puff (Tropical Blast)
Active Ingredient(s): Hydrofluoric acid 9.5mg/g
Sodium fluoride 18.5mg/g equivalent to 1.23%w/w fluoride ion
Dosage Form: Foam
New Zealand Sponsor: Ivoclar Vivadent Limited
Manufacturer(s): Pascal Company Inc, Bellevue, Washington, United States of America
Product: Puff (Verry Berry)
Active Ingredient(s): Hydrofluoric acid 9.5mg/g
Sodium fluoride 18.5mg/g equivalent to 1.23%w/w fluoride ion
Dosage Form: Foam
New Zealand Sponsor: Ivoclar Vivadent Limited
Manufacturer(s): Pascal Company Inc, Bellevue, Washington, United States of America
Product: Refresh Tears Plus
Active Ingredient(s): Carmellose sodium 5mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Allergan New Zealand Limited
Manufacturer(s): Allergan America, Hormigueros, Puerto Rico
Product: Reminyl
Active Ingredient(s): Galantamine hydrobromide 5.124mg/mL equivalent to 4mg/mL galantamine base
Dosage Form: Oral solution
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Janssen Pharmaceutica NV, Beerse, Belgium
Janssen-Cilag SpA, Borgo San Michele, Latina, Italy
Product: Reminyl
Active Ingredient(s): Galantamine hydrobromide 15.38mg equivalent to 12mg galantamine base
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Janssen Pharmaceutica NV, Beerse, Belgium
Janssen-Cilag SpA, Borgo San Michele, Latina, Italy
Product: Reminyl
Active Ingredient(s): Galantamine hydrobromide 5.127mg equivalent to 4mg galantamine base
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Janssen Pharmaceutica NV, Beerse, Belgium
Janssen-Cilag SpA, Borgo San Michele, Latina, Italy
Product: Reminyl
Active Ingredient(s): Galantamine hydrobromide 10.254mg equivalent to 8mg galantamine base
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Janssen Pharmaceutica NV, Beerse, Belgium
Janssen-Cilag SpA, Borgo San Michele, Latina, Italy
Product: Shield Gold
Active Ingredient(s): Nonoxinol 9 25mg
Dosage Form: Condom with spermicide
New Zealand Sponsor: Medisafe Limited
Manufacturer(s): Pleasure Latex Products Sdn. Bhn, Jeram, Selangor Darul Ehsan, Malaysia
Product: Trizivir
Active Ingredient(s): Abacavir sulphate 351mg equivalent to 300mg abacavir
Lamivudine 150mg
Zidovudine 300mg
Dosage Form: Tablet
New Zealand Sponsor: Glaxo Wellcome New Zealand Limited
Manufacturer(s): Glaxo Wellcome Operations, Ware, Hertfordshire, United Kingdom
Product: Ziagen
Active Ingredient(s): Abacavir sulphate 23.4mg/mL equivalent to 20mg/ml abacavir base.
Dosage Form: Oral solution
New Zealand Sponsor: Glaxo Wellcome New Zealand Limited
Manufacturer(s): Glaxo Wellcome Operations, Speke, Liverpool, United Kingdom
Product: Ziagen
Active Ingredient(s): Abacavir sulphate 351mg equivalent to 300mg abacavir per tablet
Dosage Form: Film coated tablet
New Zealand Sponsor: Glaxo Wellcome New Zealand Limited
Manufacturer(s): Glaxo Wellcome Operations, Ware, Hertfordshire, United Kingdom
Dated this 16th day of May 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).