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: Anapen 500
Active Ingredient: Adrenaline 1.66mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Link Pharmaceuticals Limited
Manufacturer: Italfarmaco S.P.A, Milano, Italy
Product: Carisa
Active Ingredient: Aspirin 100mg
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Ethos Consulting Group
Manufacturer: S C Antibiotice SA, Iasi, Romania
Product: Imipenem+Cilastatin RBX
Active Ingredients: Cilastatin sodium 530.7mg equivalent to cilastatin 500mg
Imipenem monohydrate 530.1mg equivalent to imipenem 500mg
Dosage Form: Solution for injection
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ranbaxy Laboratories Limited, Madhya Pradesh, India
Product: Letrozole
Active Ingredient: Letrozole 2.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Ozlodip
Active Ingredient: Amlodipine besilate 13.868mg equivalent to Amlodipine 10mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ranbaxy Laboratories Limited, Himachal Pradesh, India
Product: Ozlodip
Active Ingredient: Amlodipine besilate 6.934mg equivalent to Amlodipine 5mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ranbaxy Laboratories Limited, Himachal Pradesh, India
Product: Rupatal
Active Ingredient: Rupatadine fumarate 12.8mg
Dosage Form: Tablet
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturer: J. Uriach i CIA, SA, Barcelona, Spain
Product: Tobrex LA 0.3% Eye Drops
Active Ingredient: Tobramycin 0.3%w/v
Dosage Form: Eye drops, solution
New Zealand Sponsor: Alcon New Zealand Limited
Manufacturer: Alcon Cusi SA, Barcelona, Spain
Dated this 19th day of August 2011.
DEBORAH KENT, Acting Deputy Director-General, Clinical Leadership, Protection and Regulation (pursuant to delegation given by the Minister of Health on 6 July 2001).