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: Alphagan P
Active Ingredient: Brimonidine tartrate 1.5mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Allergan New Zealand Limited
Manufacturer: Allergan Sales LLC, Waco, Texas, United States of America
Product: Arrow – Loratadine
Active Ingredient: Loratadine 10mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: CTS Chemical Industries Limited, Kiryat Malachi, Israel
Product: Arrow – Paroxetine
Active Ingredient: Paroxetine hydrochloride 22.22mg equivalent to 20mg paroxetine
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Cobalt Pharmaceuticals Inc., Mississauga, Ontario, Canada
Product: Berocca Performance (original flavour)
Active Ingredients: Ascorbic acid 500mg
Biotin 0.15mg
Calcium carbonate 243.98mg equivalent to calcium 97.69mg
Calcium pantothenate 25mg
Cyanocobalamin 0.01mg
Folic acid 0.4mg
Heavy magnesium carbonate 194.82mg equivalent to magnesium 49mg
Magnesium sulphate dihydrate 328.2mg equivalent to magnesium 51mg
Monophosphothiamine 18.54mg equivalent to thiamine hydrochloride anhydrous 15mg
Nicotinamide 50mg
Pyridoxine hydrochloride 10mg
Riboflavin sodium phosphate 20.51mg equivalent to riboflavin 15mg
Zinc citrate 32.04mg
Dosage Form: Effervescent tablet
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturers: Bayer Sante Familiale, Gaillard, France
Roche Products Pty Limited, Dee Why, New South Wales, Australia
Product: Berocca Performance (tropical flavour)
Active Ingredients: Ascorbic acid 500mg
Biotin 0.15mg
Calcium carbonate 243.98mg equivalent to calcium 97.69mg
Calcium pantothenate 25mg
Cyanocobalamin 0.01mg
Folic acid 0.4mg
Heavy magnesium carbonate 194.82mg equivalent to magnesium 49mg
Magnesium sulphate dihydrate 328.2mg equivalent to magnesium 51mg
Monophosphothiamine 18.54mg equivalent to thiamine hydrochloride anhydrous 15mg
Nicotinamide 50mg
Pyridoxine hydrochloride 10mg
Riboflavin sodium phosphate 20.51mg equivalent to riboflavine 15mg
Zinc citrate 32.04mg
Dosage Form: Effervescent tablet
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturers: Bayer Sante Familiale, Gaillard, France
Roche Products Pty Limited, Dee Why, New South Wales, Australia
Product: Ciprofloxacin
Active Ingredient: Ciprofloxacin hydrochloride 291mg equivalent to ciprofloxacin 250mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bristol Pharma (New Zealand) Pty Limited
Manufacturer: IPCA Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India
Product: Ciprofloxacin
Active Ingredient: Ciprofloxacin hydrochloride 582mg equivalent to ciprofloxacin 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bristol Pharma (New Zealand) Pty Limited
Manufacturer: IPCA Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India
Product: Ciprofloxacin
Active Ingredient: Ciprofloxacin hydrochloride 873mg equivalent to ciprofloxacin 750mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bristol Pharma (New Zealand) Pty Limited
Manufacturer: IPCA Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India
Product: Enidin P
Active Ingredient: Brimonidine tartrate 1.5mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Allergan New Zealand Limited
Manufacturer: Allergan Sales LLC, Waco, Texas, United States of America
Product: Maxiclear Hayfever & Sinus Relief
Active Ingredients: Loratadine 2.5mg
Phenylephrine hydrochloride 10mg
Dosage Form: Tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Matrix Laboratories Limited, Sinnar, Nashik, Maharashta, India
Product: Maxiclear Sinus Relief
Active Ingredient: Phenylephrine hydrochloride 10mg
Dosage Form: Tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Matrix Laboratories Limited, Sinnar, Nashik, Maharashta, India
Product: Nicotinell Classic
Active Ingredient: Nicotine 2mg
Dosage Form: Chewing gum
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited
Manufacturer: Fertin Pharma A/S, Vejle, Denmark
Product: Nicotinell Classic
Active Ingredient: Nicotine 4mg
Dosage Form: Chewing gum
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited
Manufacturer: Fertin Pharma A/S, Vejle, Denmark
Product: Procip
Active Ingredient: Ciprofloxacin hydrochloride 291mg equivalent to ciprofloxacin 250mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bristol Pharma (New Zealand) Pty Limited
Manufacturer: IPCA Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India
Product: Procip
Active Ingredient: Ciprofloxacin hydrochloride 582mg equivalent to ciprofloxacin 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bristol Pharma (New Zealand) Pty Limited
Manufacturer: IPCA Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India
Product: Procip
Active Ingredient: Ciprofloxacin hydrochloride 873mg equivalent to ciprofloxacin 750mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bristol Pharma (New Zealand) Pty Limited
Manufacturer: IPCA Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India
Dated this 23rd day of November 2006.
BARRY BORMAN, Acting Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).