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Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

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: Advil
Active Ingredient: Ibuprofen 200mg
Dosage Form: Liquid filled capsule
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer: Cardinal Health Australia 401 Pty Limited, Braeside, Victoria, Australia
Product: Antinaus
Active Ingredient: Prochlorperazine maleate 5mg
Dosage Form: Tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Pacific Pharmaceuticals Limited, Mt Wellington, Auckland
Product: Dexi-Tuss Cough Linctus Junior Dry
Active Ingredient: Dextromethorphan hydrobromide 2mg/mL
Dosage Form: Linctus
New Zealand Sponsor: 3M New Zealand Limited
Manufacturer: 3M Pharmaceuticals Pty Limited, Thornleigh, New South Wales, Australia
Product: Dexi-Tuss Cough Liquid Dry
Active Ingredient: Dextromethorphan hydrobromide 2mg/mL
Dosage Form: Linctus
New Zealand Sponsor: 3M New Zealand Limited
Manufacturer: 3M Pharmaceuticals Pty Limited, Thornleigh, New South Wales, Australia
Product: Ibucare (General Sale)
Active Ingredient: Ibuprofen 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: PSM Healthcare Limited
Manufacturer: Apotex Inc, Weston, Ontario, Canada
Product: Ibucare (Pharmacy Only)
Active Ingredient: Ibuprofen 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: PSM Healthcare Limited
Manufacturer: Apotex Inc, Weston, Ontario, Canada
Product: Ibuprofen
Active Ingredient: Ibuprofen 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: IPCA Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India
Product: i-Profen
Active Ingredient: Ibuprofen 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: IPCA Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India
Product: M-Ranitidine
Active Ingredient: Ranitidine hydrochloride 168mg equivalent to ranitidine 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Wockhardt Limited, Chikalthana, Aurangabad, Maharashatra State, India
Product: M-Ranitidine
Active Ingredient: Ranitidine hydrochloride 336mg equivalent to ranitidine 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Wockhardt Limited, Chikalthana, Aurangabad, Maharashatra State, India
Product: Nurofen Plus
Active Ingredients: Codeine phosphate hemihydrate 12.8mg
Ibuprofen 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Boots Healthcare New Zealand Limited
Manufacturer: Boots Contract Manufacturing Limited, Beeston, Nottingham, England
Product: Panafen Plus
Active Ingredients: Codeine phosphate, anhydrous 12.8mg
Ibuprofen 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Dungarvan Limited, Knockbrack, Dungarvan, Co. Waterford, Ireland
Product: Paracetamol
Active Ingredient: Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: IPCA Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India
Product: Repreve
Active Ingredient: Ropinirole hydrochloride 0.285mg equivalent to ropinirole 0.25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: SmithKline Beecham Plc, Magpie Wood, Manor Royal, Crawley, Sussex, United Kingdom
Product: Repreve
Active Ingredient: Ropinirole hydrochloride 0.57mg equivalent to ropinirole 0.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: SmithKline Beecham Plc, Magpie Wood, Manor Royal, Crawley, Sussex, United Kingdom
Product: Repreve
Active Ingredient: Ropinirole hydrochloride 1.14mg equivalent to ropinirole 1mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: SmithKline Beecham Plc, Magpie Wood, Manor Royal, Crawley, Sussex, United Kingdom
Product: Repreve
Active Ingredient: Ropinirole hydrochloride 2.28mg equivalent to ropinirole 2mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: SmithKline Beecham Plc, Magpie Wood, Manor Royal, Crawley, Sussex, United Kingdom
Product: Strattera
Active Ingredient: Atomoxetine hydrochloride 11.43mg equivalent to 10mg atomoxetine free base
Dosage Form: Capsule
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: Lilly del Caribe, Inc., Carolina, Puerto Rico
Product: Strattera
Active Ingredient: Atomoxetine hydrochloride 20.57mg equivalent to 18mg atomoxetine free base
Dosage Form: Capsule
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: Lilly del Caribe, Inc., Carolina, Puerto Rico
Product: Strattera
Active Ingredient: Atomoxetine hydrochloride 28.57mg equivalent to 25mg atomoxetine free base
Dosage Form: Capsule
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: Lilly del Caribe, Inc., Carolina, Puerto Rico
Product: Strattera
Active Ingredient: Atomoxetine hydrochloride 45.71mg equivalent to 40mg atomoxetine free base
Dosage Form: Capsule
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: Lilly del Caribe, Inc., Carolina, Puerto Rico
Product: Strattera
Active Ingredient: Atomoxetine hydrochloride 5.71mg equivalent to 5mg atomoxetine free base
Dosage Form: Capsule
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: Lilly del Caribe, Inc., Carolina, Puerto Rico
Product: Strattera
Active Ingredient: Atomoxetine hydrochloride 68.56mg equivalent to 60mg atomoxetine free base
Dosage Form: Capsule
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: Lilly del Caribe, Inc., Carolina, Puerto Rico
Product: Suboxone
Active Ingredients: Buprenorphine hydrochloride 2.16mg equivalent to 2mg buprenorphine
Naloxone hydrochloride dihydrate 0.61mg equivalent to 0.5mg naloxone
Dosage Form: Sublingual tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare (UK) Limited, Hull, North Humberside, United Kingdom
Product: Suboxone
Active Ingredients: Buprenorphine hydrochloride 8.64mg equivalent to 8mg buprenorphine
Naloxone hydrochloride dihydrate 2.44mg equivalent to 2mg naloxone
Dosage Form: Sublingual tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare (UK) Limited, Hull, North Humberside, United Kingdom
Product: Vfend
Active Ingredient: Voriconazole 40mg/mL
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer PGM, Poca Sur Cisse, France
Dated this 6th day of January 2005.
BARRY BORMAN, acting as Deputy Director-General, Public Health, for the period 5 January 2005 to 24 January 2005 (pursuant to delegation given by the Minister of Health on 6 July 2001).