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: Ibuprofen for Children
Active Ingredient: Ibuprofen 20mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Drug Houses of Australia Private Limited, Singapore
Product: Pipetam
Active Ingredients: Piperacillin sodium 4.17g equivalent to piperacillin 4g
Tazobactam sodium 0.5366g equivalent to tazobactam 0.5g
Dosage Form: Powder for injection
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Istituto Biochimico Italiano Giovanni Lorenzini SpA, Latina, Italy
Product: Saizen
Active Ingredient: Somatropin 5.83mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Merck Serono SpA, Bari, Italy
Product: Saizen
Active Ingredient: Somatropin 8mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Merck Serono SpA, Bari, Italy
Dated this 7th day of March 2013.
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).