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: Bicillin L-A
Active Ingredient: Benzathine benzylpenicillin tetrahydrate 450mg/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: King Pharmaceuticals Inc, Michigan, United States of America
Product: DBL™ Sodium Nitroprusside Concentrated Injection
Active Ingredient: Sodium nitroprusside dihydrate 25mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Hospira Inc, Kansas, United States of America
Product: Tamiflu
Active Ingredient: Oseltamivir phosphate 39.4mg/g equivalent to Oseltamivir 6mg/mL when reconstituted with 55mL of water
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: Rottendorf Pharma GmbH, Ennigerloh, Germany
Dated this 25th day of October 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).