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: DBL Rocuronium Bromide Injection
Active Ingredient: Rocuronium bromide 50mg
Dosage Form: Solution for injection
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Hospira Inc, North Carolina, United States of America
Product: Full Marks Solution
Active Ingredient: Isopropyl myristate 50%w/w
Dosage Form: Solution
New Zealand Sponsor: SSL New Zealand Limited
Manufacturer: SSL International Plc, County Durham, United Kingdom
Product: Kuvan
Active Ingredient: Sapropterin dihydrochloride 100mg equivalent to sapropterin 77mg
Dosage Form: Soluble tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturers: Excella GmbH, Feucht, Germany, Lyne Laboratories Inc, Massachusetts, United States of America
Product: ParaCode
Active Ingredients: Codeine phosphate hemihydrate 8mg equivalent to codeine 5.92mg
Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Rusan Pharma Limited, Gujarat, India
Product: Privigen
Active Ingredient: Normal immunoglobulin 10%
Dosage Form: Solution for infusion
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturers: CSL Behring LLC, Illinois, United States of America, CSL Behring AG, Bern, Switzerland
Product: Ranbaxy-Gabapentin
Active Ingredient: Gabapentin 100mg
Dosage Form: Capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ranbaxy Laboratories Limited, Himachal Pradesh, India
Product: Ranbaxy-Gabapentin
Active Ingredient: Gabapentin 300mg
Dosage Form: Capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ranbaxy Laboratories Limited, Himachal Pradesh, India
Product: Ranbaxy-Gabapentin
Active Ingredient: Gabapentin 400mg
Dosage Form: Capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ranbaxy Laboratories Limited, Himachal Pradesh, India
Product: Ranbaxy-Gabapentin
Active Ingredient: Gabapentin 600mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ranbaxy Laboratories Limited, Himachal Pradesh, India
Product: Ranbaxy-Gabapentin
Active Ingredient: Gabapentin 800mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ranbaxy Laboratories Limited, Himachal Pradesh, India
Dated this 4th day of May 2011.
MARK JACOBS, Acting 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).