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: Caphosol
Caphosol A
Active Ingredients: Dibasic sodium phosphate dodecahydrate 0.159%w/v equivalent to Dibasic sodium phosphate 0.063%w/v
Monobasic sodium phosphate dihydrate 0.024%w/v equivalent to Monobasic sodium phosphate 0.017%w/v
Sodium chloride 0.569%w/v
Dosage Form: Mouthwash
Caphosol B
Active Ingredients: Calcium chloride dihydrate 0.139%w/v equivalent to Calcium chloride 0.105%w/v
Sodium chloride 0.569%w/v
Dosage Form: Mouthwash
New Zealand Sponsor: New Zealand Medical & Scientific Limited
Manufacturer: Holopack Verpackungstechnik GmbH, Abstgmund-Untergroningen, Germany
Product: DBL™ Pemetrexed (as disodium) powder for infusion
Active Ingredient: Pemetrexed disodium trihydrate 110.28mg equivalent to Pemetrexed 100mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Zydus Hospira Oncology Limited, Gujarat, India
Product: DBL™ Pemetrexed (as disodium) powder for infusion
Active Ingredient: Pemetrexed disodium trihydrate 551.4mg equivalent to Pemetrexed 500mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Zydus Hospira Oncology Limited, Gujarat, India
Product: Durex Performax Intense
Active Ingredient: Benzocaine 1.3%
Dosage Form: Medicated condom
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: SSL Manufacturing (Thailand) Limited, Chachoengsao, Thailand
Product: Edurant
Active Ingredient: Rilpivirine hydrochloride 27.5mg equivalent to Rilpivirine free base 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen-Cilag SpA, Latina, Italy
Dated this 22nd day of June 2012.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).