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: Abacavir
Active Ingredient: Abacavir sulfate 23.4mg/mL equivalent to 20mg/mL abacavir
Dosage Form: Oral solution
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India
Product: Alendronate
Active Ingredient: Alendronate sodium trihydrate 91.37mg equivalent to 70mg alendronic acid
Dosage Form: Tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Bachupally, India
Product: Ciclopirox
Active Ingredient: Ciclopirox 8%w/w
Dosage Form: Nail lacquer
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Taro Pharmaceutical Industries Limited, Haifa Bay, Israel
Product: Epirubicin
Active Ingredient: Epirubicin hydrochloride 2mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India
Product: Finasteride
Active Ingredient: Finasteride 1mg
Dosage Form: Film coated tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Bangalore, India
Product: Moduretic
Active Ingredients: Amiloride hydrochloride dihydrate 5mg
Hydrochlorothiazide 50mg
Dosage Form: Tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Frosst Iberica SA, Madrid, Spain
Product: Pamidronate
Active Ingredient: Disodium pamidronate, anhydrous 3mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India
Product: Pamidronate
Active Ingredient: Disodium pamidronate, anhydrous 6mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India
Product: Pamidronate
Active Ingredient: Disodium pamidronate, anhydrous 9mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India
Product: Paracetamol
Active Ingredient: Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Adcock Ingram Limited - A Medreich Group Company, Bangalore, India
Product: Sterile Dopamine concentrate BP
Active Ingredient: Dopamine hydrochloride 40mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Max Health Limited
Manufacturer: Macarthys Laboratories Limited t/a Martindale Pharmaceuticals, Romford, United Kingdom
Dated this 21st day of July 2010.
JANICE WILSON, Deputy Director-General, Population Health Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on the 6th day of July 2001).