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: A-Loperamide capsules
Active Ingredient: Loperamide hydrochloride 2mg
Dosage Form: Capsule
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Silvassa, India
Product: Ceftriaxone-AFT
Active Ingredient: Ceftriaxone sodium 539.65mg equivalent to ceftriaxone 500mg
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Eczabasi-Zentiva Saglik Urunleri Sanayi ve Ticaret Anonium Sirketi, Kirklareli, Turkey
Product: Ceftriaxone-AFT
Active Ingredient: Ceftriaxone sodium 1.0793g equivalent to ceftriaxone 1g
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Eczabasi-Zentiva Saglik Urunleri Sanayi ve Ticaret Anonium Sirketi, Kirklareli, Turkey
Product: Ceftriaxone-AFT
Active Ingredient: Ceftriaxone sodium 2.1586g equivalent to ceftriaxone 2g
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Eczabasi-Zentiva Saglik Urunleri Sanayi ve Ticaret Anonium Sirketi, Kirklareli, Turkey
Product: Hemosol B0
Electrolyte Solution
Active Ingredients: Calcium chloride dihydrate 5.145g
Lactic acid 5.4g equivalent to lactic acid solution 90% w/w 6g
Magnesium chloride hexahydrate 2.033g
Dosage Form: Dialysis solution
Buffer Solution
Active Ingredients: Sodium bicarbonate 3.09g
Sodium chloride 6.45g
Dosage Form: Dialysis solution
New Zealand Sponsor: Gambro Pty Limited (NZ)
Manufacturer: Gambro Dasco SpA, Sondalo, Italy
Product: Humira
Active Ingredient: Adalimumab 20mg
Dosage Form: Solution for injection
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: I-Loperamide capsules
Active Ingredient: Loperamide hydrochloride 2mg
Dosage Form: Capsule
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Silvassa, India
Product: Loperamide capsules
Active Ingredient: Loperamide hydrochloride 2mg
Dosage Form: Capsule
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Silvassa, India
Product: Maxiclear Cold & Nasal Relief
Active Ingredients: Loratadine 2.5mg
Phenylephrine hydrochloride 10mg equivalent to phenylephrine 8.2mg
Dosage Form: Tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Sigma Laboratories Limited, Goa, India
Product: Prismasol 2 mmol/L Potassium
Electrolyte Solution
Active Ingredients: Calcium chloride dihydrate 5.145g
Glucose, anhydrous 22g equivalent to glucose monohydrate 24.200g
Lactic acid 5.4g equivalent to lactic acid solution 90% w/w 6g
Magnesium chloride hexahydrate 2.033g
Dosage Form: Dialysis solution
Buffer Solution
Active Ingredients: Potassium chloride 0.157g
Sodium bicarbonate 3.09g
Sodium chloride 6.45g
Dosage Form: Dialysis solution
New Zealand Sponsor: Gambro Pty Limited (NZ)
Manufacturer: Gambro Dasco SpA, Sondalo, Italy
Product: Prismasol 4 mmol/L Potassium
Electrolyte Solution
Active Ingredients: Calcium chloride dihydrate 5.145g
Glucose, anhydrous 22g equivalent to glucose monohydrate 24.200g
Lactic acid 5.4g equivalent to lactic acid solution 90% w/w 6g
Magnesium chloride hexahydrate 2.033g
Dosage Form: Dialysis solution
Buffer Solution
Active Ingredients: Potassium chloride 0.314g
Sodium bicarbonate 3.09g
Sodium chloride 6.45g
Dosage Form: Dialysis solution
New Zealand Sponsor: Gambro Pty Limited (NZ)
Manufacturer: Gambro Dasco SpA, Sondalo, Italy
Dated this 10th day of January 2011.
JANICE WILSON, Deputy Director-General, Population Health Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).