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 – Quinapril
Active Ingredient: Quinapril hydrochloride 10.832mg equivalent to 10mg quinapril
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Lupin Limited, Verna Industrial Area, Verna, Salcette, Goa, India
Product: Apo – Quinapril
Active Ingredient: Quinapril hydrochloride 21.664mg equivalent to 20mg quinapril
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Lupin Limited, Verna Industrial Area, Verna, Salcette, Goa, India
Product: Apo – Quinapril
Active Ingredient: Quinapril hydrochloride 5.416mg equivalent to 5mg quinapril
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Lupin Limited, Verna Industrial Area, Verna, Salcette, Goa, India
Product: Bicalox
Active Ingredient: Bicalutamide 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Manufacturing Limited, Lincoln, Auckland
Product: Cephalexin ABM
Active Ingredient: Cefalexin monohydrate equivalent to 250mg Cefalexin anhydrous
Dosage Form: Capsule
New Zealand Sponsor: ABM Pharma Limited
Manufacturer: Lupin Limited, Mandideep, District Raisen, Madhya Pradesh, India
Product: Cephalexin ABM
Active Ingredient: Cefalexin monohydrate equivalent to 500mg Cefalexin anhydrous
Dosage Form: Capsule
New Zealand Sponsor: ABM Pharma Limited
Manufacturer: Lupin Limited, Mandideep, District Raisen, Madhya Pradesh, India
Product: Fluorescein Novartis
Active Ingredient: Fluorescein sodium 500mg
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: B Braun Melsungen AG, Berlin, Germany
Product: Oraqix Periodontal Gel
Active Ingredients: Lidocaine 25mg/g
Prilocaine 25mg/g
Dosage Form: Oral gel
New Zealand Sponsor: Dentsply New Zealand
Manufacturer: Recipharm Karlskoga AB, Bjorkborn, Karlskoga, Sweden
Dated this 22nd day of April 2008.
JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).