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: Aricept-D
Active Ingredient: Donepezil hydrochloride 10mg
Dosage Form: Orally disintegrating tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Eisai Co Limited, Misato-machi, Kodama-gun, Saitama-ken, Japan
Product: Aricept-D
Active Ingredient: Donepezil hydrochloride 5mg
Dosage Form: Orally disintegrating tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Eisai Co Limited, Misato-machi, Kodama-gun, Saitama-ken, Japan
Product: Arrow - Gabapentin
Active Ingredient: Gabapentin 100mg
Dosage Form: Capsule
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturers: Cobalt Pharmaceuticals Inc., Mississauga, Ontario, Canada
Rivopharm SA, Manno, Switzerland
Product: Arrow - Gabapentin
Active Ingredient: Gabapentin 300mg
Dosage Form: Capsule
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturers: Cobalt Pharmaceuticals Inc., Mississauga, Ontario, Canada
Rivopharm SA, Manno, Switzerland
Product: Arrow - Gabapentin
Active Ingredient: Gabapentin 400mg
Dosage Form: Capsule
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturers: Cobalt Pharmaceuticals Inc., Mississauga, Ontario, Canada
Rivopharm SA, Manno, Switzerland
Product: Colgate NeutraFluor Gel - Fresh Mint
Active Ingredient: Sodium fluoride 1.1%w/w equivalent to fluoride ion 5000ppm
Dosage Form: Oral gel
New Zealand Sponsor: Colgate-Palmolive Limited
Manufacturer: Colgate Oral Pharmaceuticals, Dallas, Texas, United States of America
Product: Colgate NeutraFluor Gel - Very Berry
Active Ingredient: Sodium fluoride 1.1%w/w equivalent to fluoride ion 5000ppm
Dosage Form: Oral gel
New Zealand Sponsor: Colgate-Palmolive Limited
Manufacturer: Colgate Oral Pharmaceuticals, Dallas, Texas, United States of America
Product: Gliclazide
Active Ingredient: Gliclazide 80mg
Dosage Form: Tablet
New Zealand Sponsor: Bristol Pharma (New Zealand) Pty Limited
Manufacturer: IPCA Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India
Product: Glycinorm
Active Ingredient: Gliclazide 80mg
Dosage Form: Tablet
New Zealand Sponsor: Bristol Pharma (New Zealand) Pty Limited
Manufacturer: IPCA Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India
Product: Medical Oxygen
Active Ingredient: Oxygen 99.5%
Dosage Form: Gas
New Zealand Sponsor: Gas Matters Limited
Manufacturer: Air Liquide New Zealand Limited, Penrose, Auckland
Product: Navelbine
Active Ingredient: Vinorelbine tartrate 27.7mg equivalent to vinorelbine 20mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Pierre Fabre Medicament Australia Pty Limited
Manufacturer: R P Scherer & Co. KG., Eberbach/Baden, Germany
Product: Navelbine
Active Ingredient: Vinorelbine tartrate 41.55mg equivalent to vinorelbine 30mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Pierre Fabre Medicament Australia Pty Limited
Manufacturer: R P Scherer & Co. KG., Eberbach/Baden, Germany
Product: Navelbine
Active Ingredient: Vinorelbine tartrate 55.4mg equivalent to vinorelbine 40mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Pierre Fabre Medicament Australia Pty Limited
Manufacturer: R P Scherer & Co. KG., Eberbach/Baden, Germany
Product: Navelbine
Active Ingredient: Vinorelbine tartrate 110.8mg equivalent to vinorelbine 80mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Pierre Fabre Medicament Australia Pty Limited
Manufacturer: R P Scherer & Co. KG., Eberbach/Baden, Germany
Product: Omegaven
Active Ingredients: Egg lecithin 1.2%w/v
Fish oil - highly refined. 10%w/v
Glycerol 2.5%w/v
Dosage Form: Emulsion for infusion
New Zealand Sponsor: Pharmatel Fresenius Kabi NZ Limited
Manufacturers: Fresenius Kabi Austria GmbH, Graz, Austria
Fresenius Kabi Deutschland GmbH, Friedberg, Germany
Product: Ondansetron
Active Ingredient: Ondansetron hydrochloride dihydrate 4.5mg equivalent to Ondansetron 4mg
Dosage Form: Solution for injection
New Zealand Sponsor: Mayne Pharma (NZ) Limited
Manufacturers: Mayne Pharma (Puerto Rico) Inc, Ramey Branch, Aguadilla, Puerto Rico
Mayne Pharma Limited, Mulgrave North, Victoria, Australia
Product: Ondansetron
Active Ingredient: Ondansetron hydrochloride dihydrate 9mg equivalent to Ondansetron 8mg
Dosage Form: Solution for injection
New Zealand Sponsor: Mayne Pharma (NZ) Limited
Manufacturers: Mayne Pharma (Puerto Rico) Inc, Ramey Branch, Aguadilla, Puerto Rico
Mayne Pharma Limited, Mulgrave North, Victoria, Australia
Product: Oxaliplatin Dakota
Active Ingredient: Oxaliplatin 100mg
Dosage Form: Powder for infusion
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturers: Ben Venue Laboratories Inc, Bedford, Ohio, United States of America
Laboratoires Thissen SA, Braine-L’Alleud, Belgium
Product: Oxaliplatin Dakota
Active Ingredient: Oxaliplatin 50mg
Dosage Form: Powder for infusion
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturers: Ben Venue Laboratories Inc, Bedford, Ohio, United States of America
Laboratoires Thissen SA, Braine-L’Alleud, Belgium
Product: Oxaliplatin Winthrop
Active Ingredient: Oxaliplatin 100mg
Dosage Form: Powder for infusion
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturers: Ben Venue Laboratories Inc, Bedford, Ohio, United States of America
Laboratoires Thissen SA, Braine-L’Alleud, Belgium
Product: Oxaliplatin Winthrop
Active Ingredient: Oxaliplatin 50mg
Dosage Form: Powder for infusion
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturers: Ben Venue Laboratories Inc, Bedford, Ohio, United States of America
Laboratoires Thissen SA, Braine-L’Alleud, Belgium
Product: Tramal SR 50
Active Ingredient: Tramadol hydrochloride 50mg
Dosage Form: Modified release tablet
New Zealand Sponsor: CSL New Zealand Limited
Manufacturers: Farmaceutici Formenti Italy, Origgio (VA), Italy
Grunenthal GmbH, Stolberg, Germany
Product: Vinorelbine Pierre Fabre
Active Ingredient: Vinorelbine tartrate 27.7mg equivalent to vinorelbine 20mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Pierre Fabre Medicament Australia Pty Limited
Manufacturer: R P Scherer & Co. KG., Eberbach/Baden, Germany
Product: Vinorelbine Pierre Fabre
Active Ingredient: Vinorelbine tartrate 41.55mg equivalent to vinorelbine 30mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Pierre Fabre Medicament Australia Pty Limited
Manufacturer: R P Scherer & Co. KG., Eberbach/Baden, Germany
Product: Vinorelbine Pierre Fabre
Active Ingredient: Vinorelbine tartrate 55.4mg equivalent to vinorelbine 40mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Pierre Fabre Medicament Australia Pty Limited
Manufacturer: R P Scherer & Co. KG., Eberbach/Baden, Germany
Product: Vinorelbine Pierre Fabre
Active Ingredient: Vinorelbine tartrate 110.8mg equivalent to vinorelbine 80mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Pierre Fabre Medicament Australia Pty Limited
Manufacturer: R P Scherer & Co. KG., Eberbach/Baden, Germany
Product: Winthrop Oxaliplatin
Active Ingredient: Oxaliplatin 100mg
Dosage Form: Powder for infusion
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturers: Ben Venue Laboratories Inc, Bedford, Ohio, United States of America
Laboratoires Thissen SA, Braine-L’Alleud, Belgium
Product: Winthrop Oxaliplatin
Active Ingredient: Oxaliplatin 50mg
Dosage Form: Powder for infusion
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturers: Ben Venue Laboratories Inc, Bedford, Ohio, United States of America
Laboratoires Thissen SA, Braine-L’Alleud, Belgium
Dated this 26th day of October 2006.
KAREN MITCHELL, Acting Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).