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: Arrow - Quetiapine 100
Active Ingredient: Quetiapine fumarate 115.12mg equivalent to 100mg quetiapine
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Laboratories Limited, Croydon, Australia
Product: Arrow - Quetiapine 150
Active Ingredient: Quetiapine fumarate 172.68mg equivalent to 150mg quetiapine
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Laboratories Limited, Croydon, Australia
Product: Arrow - Quetiapine 200
Active Ingredient: Quetiapine fumarate 230.24mg equivalent to 200mg quetiapine
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Laboratories Limited, Croydon, Australia
Product: Arrow - Quetiapine 25
Active Ingredient: Quetiapine fumarate 28.78mg equivalent to 25mg quetiapine
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Laboratories Limited, Croydon, Australia
Product: Arrow - Quetiapine 300
Active Ingredient: Quetiapine fumarate 345.36mg equivalent to 300mg quetiapine
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Laboratories Limited, Croydon, Australia
Product: Benadryl Mucus Relief Double Action
Active Ingredients: Bromhexine hydrochloride 0.6mg/mL
Guaifenesin 20mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Probiotec Pharma Pty Limited, Laverton North, Australia
Product: Cisplatin
Active Ingredient: Cisplatin 1mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India
Product: Dr Reddy’s Omeprazole
Active Ingredient: Omeprazole 10mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Bachupally, India
Product: Itcozol
Active Ingredient: Itraconazole 100mg
Dosage Form: Capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Laboratorios Liconsa S.A., Miralcampo, Spain
Product: Omeflux
Active Ingredient: Omeprazole 10mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Bachupally, India
Product: Requip Modutab
Active Ingredient: Ropinirole hydrochloride 2.28mg equivalent to 2.0mg ropinirole
Dosage Form: Modified release tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: SmithKline Beecham Pharmaceuticals Limited, Crawley, United Kingdom
Product: Requip Modutab
Active Ingredient: Ropinirole hydrochloride 3.42mg equivalent to 3mg ropinirole
Dosage Form: Modified release tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: SmithKline Beecham Pharmaceuticals Limited, Crawley, United Kingdom
Product: Requip Modutab
Active Ingredient: Ropinirole hydrochloride 4.56mg equivalent to 4mg ropinirole
Dosage Form: Modified release tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: SmithKline Beecham Pharmaceuticals Limited, Crawley, United Kingdom
Product: Requip Modutab
Active Ingredient: Ropinirole hydrochloride 9.12mg equivalent to ropinirole 8mg
Dosage Form: Tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: SmithKline Beecham Pharmaceuticals Limited, Crawley, United Kingdom
Product: Rimane
Active Ingredient: Rivastigmine tartrate 2.4mg equivalent to 1.5mg rivastigmine
Dosage Form: Capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Pharmaceuticals (Fiji) Limited, Nadi, Fiji
Product: Rimane
Active Ingredient: Rivastigmine tartrate 4.8mg equivalent to 3mg rivastigmine
Dosage Form: Capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Pharmaceuticals (Fiji) Limited, Nadi, Fiji
Product: Rimane
Active Ingredient: Rivastigmine tartrate 7.2mg equivalent to 4.5mg rivastigmine
Dosage Form: Capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Pharmaceuticals (Fiji) Limited, Nadi, Fiji
Product: Rimane
Active Ingredient: Rivastigmine tartrate 9.6mg equivalent to 6mg rivastigmine
Dosage Form: Capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Pharmaceuticals (Fiji) Limited, Nadi, Fiji
Product: Stalevo
Active Ingredients: Carbidopa monohydrate 20.25mg equivalent to 18.75mg carbidopa
Entacapone 200mg
Levodopa 75mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Orion Corporation, Espoo, Finland
Product: Stalevo
Active Ingredients: Carbidopa monohydrate 33.8mg equivalent to 31.25mg carbidopa
Entacapone 200mg
Levodopa 125mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Orion Corporation, Espoo, Finland
Product: Vicks Sinex Nasal Spray
Active Ingredient: Oxymetazoline hydrochloride 0.05%w/v
Dosage Form: Nasal spray solution
New Zealand Sponsor: Procter & Gamble Distributing New Zealand Limited
Manufacturer: Procter & Gamble GmbH, Gross Gerau, Germany
Product: Vicks Sinex ExtraFresh nasal spray
Active Ingredient: Oxymetazoline hydrochloride 0.05%w/v
Dosage Form: Nasal spray solution
New Zealand Sponsor: Procter & Gamble Distributing New Zealand Limited
Manufacturer: Procter & Gamble GmbH, Gross Gerau, Germany
Dated this 24th day of June 2010.
STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).