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: Amlodipine
Active Ingredient: Amlodipine besilate 6.94mg equivalent to 5.0mg amlodipine base
Dosage Form: Tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Goa, India
Product: Amlodipine
Active Ingredient: Amlodipine besilate 13.87mg equivalent to 10.0mg amlodipine base
Dosage Form: Tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Goa, India
Product: Drixine No Drip Formula Pump Mist Nasal Spray
Active Ingredient: Oxymetazoline hydrochloride 0.05%w/w
Dosage Form: Nasal spray solution
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Contract Pharmaceuticals Limited, Ontario, Canada
Product: Finasteride
Active Ingredient: Finasteride 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Bangalore, India
Product: Ondansetron
Active Ingredient: Ondansetron hydrochloride dihydrate 2.5mg/mL equivalent to Ondansetron 2mg
Dosage Form: Solution for injection
New Zealand Sponsor: REX Medical Limited
Manufacturer: Gland Pharma Limited, Hyderabad, India
Product: Zidovudine 300mg / Lamivudine 150mg
Active Ingredients: Zidovudine 300mg
Lamivudine 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Goa, India
Dated this 8th day of April 2010.
ANTHONY HILL, Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).