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: Ceptolate
Active Ingredient: Mycophenolate mofetil 250mg
Dosage Form: Capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan LLC, Caguas, Puerto Rico
Product: Evoltra
Active Ingredient: Clofarabine 20mg
Dosage Form: Concentrate for injection
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Pharmachemie BV Haarlem, The Netherlands
Product: Fiorinal Tension Headache (Pharmacy Only)
Active Ingredients Caffeine 65mg
Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited (New Zealand)
Manufacturer: Novartis Consumer Health Inc., Nebraska, United States of America
Product: Fiorinal Tension Headache (General Sale)
Active Ingredients: Caffeine 65mg
Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited (New Zealand)
Manufacturer: Novartis Consumer Health Inc., Nebraska, United States of America
Product: Lincocin
Active Ingredient: Lincomycin hydrochloride monohydrate 340.26mg/mL equivalent to lincomycin 300mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Manufacturing Belgium NV, Puurs, Belgium
Pharmacia & Upjohn Company, Michigan, United States of America
Product: Midaccord
Active Ingredient: Midazolam 1mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Ahmedabad, India
Product: Midaccord
Active Ingredient: Midazolam 5mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Ahmedabad, India
Product: Your Pharmacy Dry Cough Syrup
Active Ingredient: Dextromethorphan hydrobromide, anhydrous 1mg
Dosage Form: Solution
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand
Dated this 10th day of February 2011.
BARBARA PHILLIPS, Acting Deputy Director-General, Population Health Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).