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: Apo-Valaciclovir
Active Ingredient: Valaciclovir hydrochloride monohydrate 584mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Valaciclovir
Active Ingredient: Valaciclovir hydrochloride monohydrate 1168mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Frusemide Pfizer
Active Ingredient: Furosemide 10mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Claris Life Sciences Limited, Gujarat, India
Product: Risperidone
Active Ingredient: Risperidone 1mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Wockhardt Limited, Himachal Pradesh, India
Product: Rocuronium
Active Ingredient: Rocuronium bromide 1%w/v
Dosage Form: Solution for injection
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Gland Pharma Limited, Hyderabad, India
Dated this 30th day of June 2011.
JOHN HOLMES, 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).