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-Simvastatin
Active Ingredient: Simvastatin 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Lupin Limited, Verna, Salcette, Goa, India
Product: Apo-Simvastatin
Active Ingredient: Simvastatin 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Lupin Limited, Verna, Salcette, Goa, India
Product: Apo-Simvastatin
Active Ingredient: Simvastatin 40mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Lupin Limited, Verna, Salcette, Goa, India
Product: Apo-Simvastatin
Active Ingredient: Simvastatin 80mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Lupin Limited, Verna, Salcette, Goa, India
Product: Lamitor DT
Active Ingredient: Lamotrigine 25mg
Dosage Form: Dispersible tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Torrent Pharmaceuticals Limited, Taluka, Kadi, Gujarat, India
Product: Lamitor DT
Active Ingredient: Lamotrigine 100mg
Dosage Form: Dispersible tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Torrent Pharmaceuticals Limited, Taluka, Kadi, Gujarat, India
Product: Lamitor DT
Active Ingredient: Lamotrigine 200mg
Dosage Form: Dispersible tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Torrent Pharmaceuticals Limited, Taluka, Kadi, Gujarat, India
Product: Lamitor DT
Active Ingredient: Lamotrigine 50mg
Dosage Form: Dispersible tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Torrent Pharmaceuticals Limited, Taluka, Kadi, Gujarat, India
Product: Meloxicam
Active Ingredient: Meloxicam 15mg
Dosage Form: Tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Manufacturing Division, Kurkumbh Village, Taluka - Daund, District - Pune, Maharashtra State, India
Product: Meloxicam
Active Ingredient: Meloxicam 7.5mg
Dosage Form: Tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Manufacturing Division, Kurkumbh Village, Taluka - Daund, District - Pune, Maharashtra State, India
Product: Pantoprazole 20mg tablet
Active Ingredient: Pantoprazole sodium sesquihydrate 22.55mg equivalent to pantoprazole base 20mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Affordable Healthcare Limited
Manufacturer: Dr Reddy's Laboratories Limited, Generics, Bachepalli, Andhra Pradesh, India
Product: Pantoprazole 40mg tablet
Active Ingredient: Pantoprazole sodium sesquihydrate 45.1mg equivalent to pantoprazole base 40mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Affordable Healthcare Limited
Manufacturer: Dr Reddy's Laboratories Limited, Generics, Bachepalli, Andhra Pradesh, India
Dated this 8th day of November 2007.
MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).